Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-02-21 @ 9:44 AM
Study NCT ID:
NCT04565756
Status:
COMPLETED
Last Update Posted:
2025-05-09
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Tolerability of EXN407
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'loic.lhuillier@exonate.com', 'phone': '+44 (0)1223 734716', 'title': 'Loic Lhuillier', 'organization': 'Exonate'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Each subject in the Dose Escalation cohorts (numbered Cohorts 1, 2, 3, etc.) received EXN407 or vehicle BID over a 7-day period Each subject in the Dose Expansion received EXN407 or vehicle BID over an 84-day period', 'description': 'Assessed starting from Day 1 of treatment to Day 36 in Dose Expansion phase. Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase. Arms/Groups are combined (not separated into study eye and fellow eye) as both ocular and non-ocular adverse events are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Dose Escalation EXN407 Cohort 1', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose Escalation EXN407 Cohort 2', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose Escalation EXN407 Cohort 3', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Dose Escalation Pooled Placebo Cohort', 'description': 'Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Dose Expansion EXN407 Cohort', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 11, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Dose Expansion Placebo Cohort', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 9, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Blepharitis', 'notes': '1 subject in the 0.5 mg/mL EXN407 cohort (#108-001) had 1 event of mild seborrheic blepharitis (bilateral affecting both eyes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Posterior capsule opacification', 'notes': '1 subject in the 1.0 mg/mL group (#109-004) had 1 event of right posterior capsule opacification (bilateral affecting both eyes).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Vision blurred', 'notes': '1 subject in the 0.5 mg/mL EXN407 cohort (#106-006) had 1 event of blurred vision in mornings (bilateral affecting both eyes).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Eye pruritus', 'notes': '2 subjects in the EXN407 group (#103-009 and #108-018) had 2 events (1 event each in study eye) of eye pruritis (left itchy eye and right itchy eye, respectively).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Episcleritis', 'notes': 'Episcleritis. 1 subject in the placebo group (#112-006) had 1 event of episcleritis right eye (study eye).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Dizziness', 'notes': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Visual field defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Blood phosphorus decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Electrocardiogram ST segment elevation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Punctate keratiis', 'notes': '1 subject in the placebo group (#108-024) had 1 event of punctate epithelial erosions right eye (study eye).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Foreign body sensation in eyes', 'notes': '1 subject in the placebo group (#112-002) had 1 event of foreign body sensation right eye (study eye).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Cataract cortical', 'notes': '1 subject in the placebo group (#108-015) had 1 event of increase in degree of cortical cataract (bilateral affecting both eyes).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Eye irritation', 'notes': '1 subject in the placebo group (#112-002) had 1 event of irritation - right eye (study eye).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Sinus bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'Acrochordon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'seriousEvents': [{'term': 'Angina pectoris', 'notes': 'single instance of moderate angina pectoris (atypical chest pain) that was assessed as unlikely related to the study drug. The study drug was interrupted, and the event resolved within 23 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'non-ST elevation acute coronary syndrome', 'notes': 'single instance of severe acute coronary syndrome (non-ST elevation acute coronary syndrome) that was assessed as unlikely related to the study drug. The study drug was interrupted, and the event resolved within 10 days.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}, {'term': 'severe hypoglycaemia', 'notes': 'single instance of severe hypoglycaemia (severe hypoglycaemia) that was assessed as unlikely related to the study drug. The study drug was not changed, and the event resolved within 1 day without treatment.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Primary Objective of the Study is to Evaluate the Ocular Safety and Tolerability (by Incidence of Ocular Adverse Events) of EXN407 Ophthalmic Solution in Dose Escalation Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '4', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation EXN407 Cohort 1 Study Eye', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG001', 'title': 'Dose Escalation EXN407 Cohort 1 Contralateral Eye', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG002', 'title': 'Dose Escalation EXN407 Cohort 1, Bilateral Eye', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG003', 'title': 'Dose Escalation EXN407 Cohort 2 Study Eye', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG004', 'title': 'Dose Escalation EXN407 Cohort 2 Contralateral Eye', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG005', 'title': 'Dose Escalation EXN407 Cohort 2 Bilateral Eye', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG006', 'title': 'Dose Escalation EXN407 Cohort 3 Study Eye', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG007', 'title': 'Dose Escalation EXN407 Cohort 3 Contralateral Eye', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG008', 'title': 'Dose Escalation EXN407 Cohort 3 Bilateral Eye', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG009', 'title': 'Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye', 'description': 'Data from the placebo subjects was pooled (as appropriate).'}, {'id': 'OG010', 'title': 'Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye', 'description': 'Data from the placebo subjects was pooled (as appropriate).'}, {'id': 'OG011', 'title': 'Pooled Placebo (Cohort 1, Cohort 2, Cohort) Bilateral Eye', 'description': 'Data from the placebo subjects was pooled (as appropriate).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003', 'OG006', 'OG009'], 'groupDescription': 'Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables. All statistical analyses were descriptive in nature and any statistical inferences were carried out according to the analysis plan and interpreted in view of the exploratory nature of the study.', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'Since the primary objective of the study was to evaluate ocular safety and tolerability, no formal hypothesis testing was performed for any continuous or categorical variables.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed starting from Day 1 of treatment to Day 36 in Dose Escalation.', 'description': 'Number of Participants with Ocular Treatment Emergent Adverse Events (TEAEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population comprised all randomised subjects who received any amount of study drug. Summaries, listings, and analyses were based on the treatment actually received. Screen failures and randomised subjects who did not receive any medication were excluded from the safety analysis set.\n\nThe Safety population was used for the summaries of all safety assessments.'}, {'type': 'PRIMARY', 'title': 'The Primary Objective of the Study is to Evaluate the Ocular Safety and Tolerability (by Incidence of Ocular Adverse Events) of EXN407 Ophthalmic Solution in Dose Expansion Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Expansion EXN407 Cohort Study Eye', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG001', 'title': 'Dose Expansion EXN407 Cohort Contralateral Eye', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG002', 'title': 'Dose Expansion EXN407 Cohort Bilateral Eye', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG003', 'title': 'Dose Expansion Placebo Cohort Study Eye', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}, {'id': 'OG004', 'title': 'Dose Expansion Placebo Cohort Contralateral Eye', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}, {'id': 'OG005', 'title': 'Dose Expansion Placebo Cohort Bilateral Eye', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase.', 'description': 'Number of Participants with Ocular Treatment Emergent Adverse Events (TEAEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population comprised all randomised subjects who received any amount of study drug. Summaries, listings, and analyses were based on the treatment actually received. Screen failures and randomised subjects who did not receive any medication were excluded from the safety analysis set.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by Tmax.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Cohort 1 (0.5 mg/mL) Day 3', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG001', 'title': 'Dose Escalation: Cohort 2 (1.0 mg/mL) Day 3', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG002', 'title': 'Dose Escalation: Cohort 3 (1.5 mg/mL) Day 3', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG003', 'title': 'Dose Expansion Cohort (1.5 mg/mL) Day 8', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Below the level of detection', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.000000000123', 'groupId': 'OG002'}, {'value': '0.494', 'spread': '0.276', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.', 'description': 'Measured by characterizing the PK profile by estimating the time of the maximum plasma drug concentration (Tmax) of EXN407 in plasma.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with detectable values were analyzed. Limited quantifiable concentration-time data was available for this study, as such the plasma PK characteristics of EXN407, in particular the dose dependency, could not be comprehensively characterised. In the low dose group (0.5 mg/mL), PK parameters could not be determined due to a lack of quantifiable concentration-time data.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Cohort 1 (0.5 mg/mL) Day 3', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG001', 'title': 'Dose Escalation: Cohort 2 (1.0 mg/mL) Day 3', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG002', 'title': 'Dose Escalation: Cohort 3 (1.5 mg/mL) Day 3', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG003', 'title': 'Dose Expansion Cohort (1.5 mg/mL) Day 8', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Below the level of detection', 'groupId': 'OG000'}, {'value': '0.0571', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.0831', 'spread': '0.0253', 'groupId': 'OG002'}, {'value': '0.0883', 'spread': '0.0410', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.', 'description': 'Measured by characterizing the PK profile by estimating the maximum observed drug plasma concentration (Cmax) of EXN407 in plasma.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with detectable values were analyzed. Limited quantifiable concentration-time data was available for this study, as such the plasma PK characteristics of EXN407, in particular the dose dependency, could not be comprehensively characterised. In the low dose group (0.5 mg/mL), PK parameters could not be determined due to a lack of quantifiable concentration-time data.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by AUC.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Cohort 1 (0.5 mg/mL) Day 3', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG001', 'title': 'Dose Escalation: Cohort 2 (1.0 mg/mL) Day 3', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG002', 'title': 'Dose Escalation: Cohort 3 (1.5 mg/mL) Day 3', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG003', 'title': 'Dose Expansion Cohort (1.5 mg/mL) Day 8', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Below the level of detection', 'groupId': 'OG000'}, {'value': '0.0368', 'spread': '0', 'groupId': 'OG001'}, {'value': '0.153', 'spread': '0.205', 'groupId': 'OG002'}, {'value': '0.0845', 'spread': '0.112', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.', 'description': 'Measured by characterizing the PK profile by estimating the area under the curve (AUC) of EXN407 in plasma.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with detectable values were analyzed. Limited quantifiable concentration-time data was available for this study, as such the plasma PK characteristics of EXN407, in particular the dose dependency, could not be comprehensively characterised. In the low dose group (0.5 mg/mL), PK parameters could not be determined due to a lack of quantifiable concentration-time data.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by t½.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Cohort 1 (0.5 mg/mL) Day 3', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG001', 'title': 'Dose Escalation: Cohort 2 (1.0 mg/mL) Day 3', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG002', 'title': 'Dose Escalation: Cohort 3 (1.5 mg/mL) Day 3', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG003', 'title': 'Dose Expansion Cohort (1.5 mg/mL) Day 8', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Below the level of detection', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.', 'description': 'Measured by characterizing the PK profile by estimating the apparent elimination half-life (t½) of EXN407 in plasma.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants with detectable values were analyzed. Limited quantifiable concentration-time data was available for this study, as such the plasma PK characteristics of EXN407, in particular the dose dependency, could not be comprehensively characterised. In the low dose group (0.5 mg/mL), PK parameters could not be determined due to a lack of quantifiable concentration-time data.'}, {'type': 'SECONDARY', 'title': 'To Evaluate Changes in Ocular Functional Measures as Assessed Using Ophthalmoscopy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Cohort 1 (0.5 mg/mL) Study Eye', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG001', 'title': 'Dose Escalation: Cohort 1 (0.5 mg/mL) Contralateral Eye', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG002', 'title': 'Dose Escalation: Cohort 2 (1.0 mg/mL) Study Eye', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG003', 'title': 'Dose Escalation: Cohort 2 (1.0 mg/mL) Contralateral Eye', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG004', 'title': 'Dose Escalation: Cohort 3 (1.5 mg/mL) Study Eye', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG005', 'title': 'Dose Escalation: Cohort 3 (1.5 mg/mL) Contralateral Eye', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG006', 'title': 'Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye', 'description': 'Data from the placebo subjects was pooled (as appropriate).'}, {'id': 'OG007', 'title': 'Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye', 'description': 'Data from the placebo subjects was pooled (as appropriate).'}, {'id': 'OG008', 'title': 'Dose Expansion Cohort (1.5 mg/mL) Study Eye', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG009', 'title': 'Dose Expansion Cohort (1.5 mg/mL) Contralateral Eye', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG010', 'title': 'Dose Expansion Placebo Cohort Study Eye', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}, {'id': 'OG011', 'title': 'Dose Expansion Placebo Cohort Contralateral Eye', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'spread': '8.72', 'groupId': 'OG000'}, {'value': '-5.0', 'spread': '9.54', 'groupId': 'OG001'}, {'value': '-2.0', 'spread': '2.65', 'groupId': 'OG002'}, {'value': '-1.0', 'spread': '3.61', 'groupId': 'OG003'}, {'value': '3.0', 'spread': '2.0', 'groupId': 'OG004'}, {'value': '-4.0', 'spread': '7.94', 'groupId': 'OG005'}, {'value': '-1.3', 'spread': '3.3', 'groupId': 'OG006'}, {'value': '-3.0', 'spread': '5.35', 'groupId': 'OG007'}, {'value': '-0.1', 'spread': '3.54', 'groupId': 'OG008'}, {'value': '-1.7', 'spread': '6.06', 'groupId': 'OG009'}, {'value': '1.3', 'spread': '5.14', 'groupId': 'OG010'}, {'value': '1.3', 'spread': '5.31', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 of Treatment to End of Treatment i.e. assessed upto 36 Days/EOS in Dose Escalation and upto 4 months(113 days/EOS) in Dose Expansion.', 'description': 'Measured by the changes from baseline in ophthalmic examination finding through ophthalmoscopy (BCVA (Letters))', 'unitOfMeasure': 'BCVA (Letters)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'To Evaluate Changes in Ocular Structural Measures as Assessed Using Ophthalmoscopy.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '23', 'groupId': 'OG008'}, {'value': '23', 'groupId': 'OG009'}, {'value': '12', 'groupId': 'OG010'}, {'value': '12', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose Escalation: Cohort 1 (0.5 mg/mL) Study Eye', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG001', 'title': 'Dose Escalation: Cohort 1 (0.5 mg/mL) Contralateral Eye', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG002', 'title': 'Dose Escalation: Cohort 2 (1.0 mg/mL) Study Eye', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG003', 'title': 'Dose Escalation: Cohort 2 (1.0 mg/mL) Contralateral Eye', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG004', 'title': 'Dose Escalation: Cohort 3 (1.5 mg/mL) Study Eye', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG005', 'title': 'Dose Escalation: Cohort 3 (1.5 mg/mL) Contralateral Eye', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG006', 'title': 'Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Study Eye', 'description': 'Data from the placebo subjects was pooled (as appropriate).'}, {'id': 'OG007', 'title': 'Pooled Placebo (Cohort 1, Cohort 2, Cohort 3) Contralateral Eye', 'description': 'Data from the placebo subjects was pooled (as appropriate).'}, {'id': 'OG008', 'title': 'Dose Expansion Cohort (1.5 mg/mL) Study Eye', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG009', 'title': 'Dose Expansion Cohort (1.5 mg/mL) Contralateral Eye', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'OG010', 'title': 'Dose Expansion Placebo Cohort Study Eye', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}, {'id': 'OG011', 'title': 'Dose Expansion Placebo Cohort Contralateral Eye', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.0', 'spread': '6.93', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '8.33', 'groupId': 'OG001'}, {'value': '15.3', 'spread': '7.02', 'groupId': 'OG002'}, {'value': '11.0', 'spread': '19.08', 'groupId': 'OG003'}, {'value': '-3.0', 'spread': '4.00', 'groupId': 'OG004'}, {'value': '-10.3', 'spread': '18.93', 'groupId': 'OG005'}, {'value': '-0.8', 'spread': '3.77', 'groupId': 'OG006'}, {'value': '1.3', 'spread': '4.50', 'groupId': 'OG007'}, {'value': '0.2', 'spread': '8.61', 'groupId': 'OG008'}, {'value': '0.1', 'spread': '10.52', 'groupId': 'OG009'}, {'value': '2.4', 'spread': '11.27', 'groupId': 'OG010'}, {'value': '0.5', 'spread': '11.35', 'groupId': 'OG011'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 of Treatment to End of Treatment i.e. assessed upto 36 Days/EOS in Dose Escalation and up to 4 months(113 days) in Dose Expansion.', 'description': 'Measured by the changes from baseline in ophthalmic examination finding through ophthalmoscopy (corneal thickness).', 'unitOfMeasure': 'corneal thickness (microns)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose Escalation EXN407 Cohort 1', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'FG001', 'title': 'Dose Escalation EXN407 Cohort 2', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'FG002', 'title': 'Dose Escalation EXN407 Cohort 3', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'FG003', 'title': 'Dose Escalation Pooled Placebo Cohort', 'description': 'Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4'}, {'id': 'FG004', 'title': 'Dose Expansion EXN407 Cohort', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'FG005', 'title': 'Dose Expansion Placebo Cohort', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '23'}, {'groupId': 'FG005', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose Escalation EXN407 Cohort 1', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'BG001', 'title': 'Dose Escalation EXN407 Cohort 2', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'BG002', 'title': 'Dose Escalation EXN407 Cohort 3', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'BG003', 'title': 'Dose Escalation Pooled Placebo Cohort', 'description': 'Data from the placebo subjects in the 3 dose escalation groups was pooled giving a total of n=4'}, {'id': 'BG004', 'title': 'Dose Expansion EXN407 Cohort', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses\n\nEXN407: EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.'}, {'id': 'BG005', 'title': 'Dose Expansion Placebo Cohort', 'description': 'Dose expansion cohort consisted of subjects randomised to receive EXN407 at the selected dose or placebo (vehicle) at a 2:1 drug: placebo ratio.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '76'}, {'value': '60', 'groupId': 'BG001', 'lowerLimit': '57', 'upperLimit': '73'}, {'value': '67', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '75'}, {'value': '59', 'groupId': 'BG003', 'lowerLimit': '49', 'upperLimit': '73'}, {'value': '63', 'groupId': 'BG004', 'lowerLimit': '40', 'upperLimit': '78'}, {'value': '59', 'groupId': 'BG005', 'lowerLimit': '47', 'upperLimit': '81'}, {'value': '61', 'groupId': 'BG006', 'lowerLimit': '40', 'upperLimit': '81'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '14', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '37', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BCVA', 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'spread': '3.51', 'groupId': 'BG000'}, {'value': '83.0', 'spread': '1.00', 'groupId': 'BG001'}, {'value': '71.3', 'spread': '1.53', 'groupId': 'BG002'}, {'value': '86.3', 'spread': '5.56', 'groupId': 'BG003'}, {'value': '81.3', 'spread': '6.04', 'groupId': 'BG004'}, {'value': '83.6', 'spread': '7.44', 'groupId': 'BG005'}, {'value': '82.1', 'spread': '6.54', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'BCVA (Letters)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Corneal thickness', 'classes': [{'categories': [{'measurements': [{'value': '561.3', 'spread': '62.80', 'groupId': 'BG000'}, {'value': '526.3', 'spread': '10.02', 'groupId': 'BG001'}, {'value': '581.7', 'spread': '53.31', 'groupId': 'BG002'}, {'value': '565.8', 'spread': '25.86', 'groupId': 'BG003'}, {'value': '555.6', 'spread': '33.75', 'groupId': 'BG004'}, {'value': '548.5', 'spread': '38.35', 'groupId': 'BG005'}, {'value': '553.2', 'spread': '34.99', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'microns', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-28', 'size': 3252843, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-15T08:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2020-08-26', 'resultsFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2020-09-24', 'lastUpdatePostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-04-23', 'studyFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary Objective of the Study is to Evaluate the Ocular Safety and Tolerability (by Incidence of Ocular Adverse Events) of EXN407 Ophthalmic Solution in Dose Escalation Phase.', 'timeFrame': 'Assessed starting from Day 1 of treatment to Day 36 in Dose Escalation.', 'description': 'Number of Participants with Ocular Treatment Emergent Adverse Events (TEAEs)'}, {'measure': 'The Primary Objective of the Study is to Evaluate the Ocular Safety and Tolerability (by Incidence of Ocular Adverse Events) of EXN407 Ophthalmic Solution in Dose Expansion Phase.', 'timeFrame': 'Assessed starting from Day 1 of treatment to Day 113 in Dose Expansion phase.', 'description': 'Number of Participants with Ocular Treatment Emergent Adverse Events (TEAEs)'}], 'secondaryOutcomes': [{'measure': 'To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by Tmax.', 'timeFrame': 'Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.', 'description': 'Measured by characterizing the PK profile by estimating the time of the maximum plasma drug concentration (Tmax) of EXN407 in plasma.'}, {'measure': 'To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by Cmax', 'timeFrame': 'Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.', 'description': 'Measured by characterizing the PK profile by estimating the maximum observed drug plasma concentration (Cmax) of EXN407 in plasma.'}, {'measure': 'To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by AUC.', 'timeFrame': 'Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.', 'description': 'Measured by characterizing the PK profile by estimating the area under the curve (AUC) of EXN407 in plasma.'}, {'measure': 'To Evaluate the Systemic Pharmacokinetics of EXN407 Ophthalmic Solution in Subjects With DMO Secondary to Diabetes Mellitus by t½.', 'timeFrame': 'Blood draws for PK will be collected only on Day 3(Dose Escalation) and Day 8(Dose Expansion) at the following timepoints: pre-dose and 15 mins, 30 mins, 1, 2, 3,and 4 hours post-dose.', 'description': 'Measured by characterizing the PK profile by estimating the apparent elimination half-life (t½) of EXN407 in plasma.'}, {'measure': 'To Evaluate Changes in Ocular Functional Measures as Assessed Using Ophthalmoscopy.', 'timeFrame': 'From Day 1 of Treatment to End of Treatment i.e. assessed upto 36 Days/EOS in Dose Escalation and upto 4 months(113 days/EOS) in Dose Expansion.', 'description': 'Measured by the changes from baseline in ophthalmic examination finding through ophthalmoscopy (BCVA (Letters))'}, {'measure': 'To Evaluate Changes in Ocular Structural Measures as Assessed Using Ophthalmoscopy.', 'timeFrame': 'From Day 1 of Treatment to End of Treatment i.e. assessed upto 36 Days/EOS in Dose Escalation and up to 4 months(113 days) in Dose Expansion.', 'description': 'Measured by the changes from baseline in ophthalmic examination finding through ophthalmoscopy (corneal thickness).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'This first in human (FIH), Phase Ib/II study of EXN407 is a randomised, double-masked, vehicle-controlled, multiple dose, dose-escalating study to evaluate the safety and tolerability of EXN407 in subjects with centre involved Diabetic Macular Oedema (DMO), with Centre-subfield macular thickness (CMT) between 280-420 µm and Best corrected visual acuity (BCVA) better than or equal to 69 ETDRS score (approximate Snellen equivalent 20/40 (6/12 letters) in the study eye, which is considered secondary to diabetes mellitus.\n\nThis study will provide a basis for further clinical development of EXN407 ophthalmic solution.', 'detailedDescription': 'EXN407 or vehicle-control solution administered unilaterally to the study eye only. To select the study eye the Investigator examines the subjects and identifies which eye exhibits centre involved DMO with a CMT between 280-420 μm (as determined by SD-OCT). Further, all other inclusion/exclusion criteria required to be met.\n\nDose Escalation Cohorts The study assesses the safety and tolerability of EXN407 in eligible subjects with center involved Diabetic Macular Oedema (DMO) at up to 3 escalating dose (concentration) levels and placebo (vehicle) consisting of an excipient formulation adjusted for osmolality. EXN407 or vehicle-control administered as a single 30 μL drop by unilateral eye drop administration to the study eye only, and the drops dosed BID for 7 days. Subjects assessed throughout the treatment period for safety, tolerability, and efficacy at Follow-up visits. Each of the ascending dose subject cohorts consists of 4 subjects (3 subjects randomised to receive EXN407 and 1 subject randomised to receive placebo).\n\nDose Expansion Cohort The highest well tolerated dose of EXN407 (as recommended by the DEC) is evaluated in a subject expansion cohort in eligible subjects with center involved Diabetic Macular Oedema (DMO) which consists of up to a maximum of 40 subjects (randomised to receive EXN407 at the selected dose or vehicle at a 2:1 drug: placebo ratio). Each eligible subject in the expansion cohort to receive study drug for up to 84 days, resulting in a total of 168 doses (168 single drops of 30 μL volume) of EXN407 or vehicle.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is at least 18 years of age inclusive, at the time of signing the informed consent.\n2. BCVA better than or equal to 69 ETDRS score (approximate Snellen equivalent 20/40 or 6/12) in the study eye using the ETDRS visual acuity scale at Screening or BCVA less than 69 ETDRS score (approximate Snellen equivalent 20/50 or 6/15) but who, in the Investigator's opinion, is unsuitable for treatment with anti-VEGF by intravitreal injection or refuses it. Subjects should have no more than a 7-letter difference in BCVA at Screening and baseline visit.\n3. Ocular media is consistent with SD-OCT imaging and cataracts are not expected in the subject for the duration of the study.\n4. The subject has no other retinal disease.\n5. Subject or the subject's partner successfully demonstrates their ability to self-administer/administer eye drops at Screening, with multiple attempts allowed at the discretion of the Investigator.\n\nExclusion Criteria:\n\n1. Any other retinal disease in the study eye, other than centre involved DMO or diabetic retinopathy.\n2. Poor vision (VA 6/60 or worse) in the contralateral eye.\n3. Intraocular inflammation (including trace or greater) in the study eye. History of idiopathic or autoimmune uveitis in either eye.\n4. Use of intravitreal anti-VEGF drugs including ranibizumab, bevacizumab, aflibercept in the study eye within 6 months of the Screening Visit, or in the fellow (non study) eye within 3 months of the Screening Visit. Use of topical corticosteroids or topical non-steroidal anti-inflammatory agents in the study eye within 28 days of the Screening Visit. Use of intravitreal corticosteroids in either eye or systemic steroids within 12 months of the Screening Visit. Prior use of Iluvien (without time limitation).\n5. Within 180 days prior to the Screening visit, use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol).\n6. History of (within 90 days of Screening date) cerebral vascular accident (stroke) or MI.\n7. Significant renal impairment including subjects on chronic renal dialysis and subjects with a history of nephrectomy or kidney transplant (regardless of renal function).\n8. History of anaphylaxis, anaphylactoid (resembling anaphylaxis) reactions, or severe allergic responses.\n9. Positive pregnancy test (all female subjects of childbearing potential must have a urine β-human chorionic gonadotropin \\[hCG\\] pregnancy test performed at Screening and within 7 days prior to randomisation) or is known to be pregnant or lactating.\n10. Known to have, or history of a positive test result for, hepatitis B or C, HIV, syphilis, tuberculosis, or COVID-19."}, 'identificationModule': {'nctId': 'NCT04565756', 'briefTitle': 'A Study to Evaluate the Safety and Tolerability of EXN407', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exonate Limited'}, 'officialTitle': 'A Randomised, Double-Masked Vehicle-Controlled, Multiple Dose, Dose Escalation Study To Evaluate The Safety and Tolerability of EXN407 in Subjects With Centre Involved Diabetic Macular Oedema Secondary to Diabetes Mellitus', 'orgStudyIdInfo': {'id': 'PQ-110-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Cohort 1', 'description': 'Each subject will receive a low-dose 0.5 mg/mL (0.05%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.', 'interventionNames': ['Drug: EXN407']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Cohort 2', 'description': 'Each subject will receive a mid-dose 1 mg/mL (0.1%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.', 'interventionNames': ['Drug: EXN407']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Escalation Cohort 3', 'description': 'Each subject will receive a high-dose 1.5 mg/mL (0.15%) of EXN407 or placebo twice a day in 14 doses over a 7 day period.', 'interventionNames': ['Drug: EXN407']}, {'type': 'EXPERIMENTAL', 'label': 'Dose Expansion Cohort', 'description': 'The highest well-tolerated dose of EXN407 will be evaluated where subjects will receive EXN407 at the selected dose or placebo twice a day for up to 84 days resulting in a total of 168 doses', 'interventionNames': ['Drug: EXN407']}], 'interventions': [{'name': 'EXN407', 'type': 'DRUG', 'description': 'EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.', 'armGroupLabels': ['Dose Escalation Cohort 1', 'Dose Escalation Cohort 2', 'Dose Escalation Cohort 3', 'Dose Expansion Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2109', 'city': 'Macquarie', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Macquarie University'}, {'zip': '2150', 'city': 'Parramatta', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Marsden Eye Specialists', 'geoPoint': {'lat': -33.8178, 'lon': 151.00348}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Eye Hospital/Save Sight Institution', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2135', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Strathfield Retina Clinic', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '2298', 'city': 'Waratah', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Newcastle Eye Hospital Foundation', 'geoPoint': {'lat': -32.90667, 'lon': 151.72647}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Adelaide Eye and Retina Centre', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Centre for Eye Research Australia (CERA)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3146', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Retinology Institute', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Lions Eye Institute', 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'city': 'Sydney', 'country': 'Australia', 'facility': 'Sydney Retina Clinic & Day Surgery', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'overallOfficials': [{'name': 'Mark Gillies, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sydney Eye Hospital/Save Sight Institution'}, {'name': 'Andrew Chang, A/Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sydney Retina Clinic & Day Surgery'}, {'name': 'Sanjeewa Wickremasinghe,, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Eye Research Australia (CERA)'}, {'name': 'Fred Chen, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lions Eye Institute'}, {'name': 'Jolly Gilhotra, A/Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Adelaide Eye and Retina Centre'}, {'name': 'Wilson Heriot, A/Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZAVe Clinical Research Management - Retinology Institute'}, {'name': 'Hemal Mehta, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Strathfield Retina Clinic'}, {'name': 'Peter Davies, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Newcastle Eye Hospital Foundation'}, {'name': 'Rohan Merani, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Macquarie University'}, {'name': 'Helene Cass, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Marsden Eye Specialists'}, {'name': 'Lily Ooi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Alexandra Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exonate Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novotech (Australia) Pty Limited', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}