Viewing Study NCT02555306

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Ignite Creation Date: 2025-12-26 @ 2:43 PM
Ignite Modification Date: 2026-01-26 @ 11:15 AM
Study NCT ID: NCT02555306
Status: COMPLETED
Last Update Posted: 2020-01-14
First Post: 2015-09-13
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579557', 'term': 'carotuximab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'evelyn.chikere@santen.com', 'phone': '+1 415 268 9199', 'title': 'R&D Quality Manager', 'organization': 'Santen Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From Visit 1 (Day 1) to Study Exit (Day 90)]', 'eventGroups': [{'id': 'EG000', 'title': '0.5 mg of DE-122', 'description': 'Single intravitreal injection of Low Dose DE-122', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '1.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-Low Dose DE-122', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '2.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-High Dose DE-122', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '4.0 mg of DE-122', 'description': 'Single intravitreal injection of High Dose DE-122', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Deposit eye', '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': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Foreign body sensation in 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': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyphaema', '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': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lacrimation 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': 3, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Photophobia', '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': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retinal haemorrhage', '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': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vision blurred', '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': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neck 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': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'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': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mg of DE-122', 'description': 'Single intravitreal injection of Low Dose DE-122 Injectable Solution'}, {'id': 'OG001', 'title': '1.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution'}, {'id': 'OG002', 'title': '2.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution'}, {'id': 'OG003', 'title': '4.0 mg of DE-122', 'description': 'Single intravitreal injection of High Dose DE-122 Injectable Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.3', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '5.0', 'groupId': 'OG001'}, {'value': '1.0', 'spread': '7.9', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '4.5', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day1) and Day 90.', 'description': 'BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \\[0, 97\\] in ETDRS letters.\n\nAn increase in BCVA indicates an improvement in the best corrected vision.', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Central Subfield Thickness (CST) at Day 90.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '0.5 mg of DE-122', 'description': 'Single intravitreal injection of Low Dose DE-122 Injectable Solution'}, {'id': 'OG001', 'title': '1.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution'}, {'id': 'OG002', 'title': '2.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution'}, {'id': 'OG003', 'title': '4.0 mg of DE-122', 'description': 'Single intravitreal injection of High Dose DE-122 Injectable Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-116.3', 'spread': '194.9', 'groupId': 'OG000'}, {'value': '62.7', 'spread': '68.1', 'groupId': 'OG001'}, {'value': '-36.0', 'spread': '42.6', 'groupId': 'OG002'}, {'value': '-111.3', 'spread': '171.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day1) and Day 90.', 'description': 'Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '0.5 mg of DE-122', 'description': 'Single intravitreal injection of Low Dose DE-122 Injectable Solution'}, {'id': 'FG001', 'title': '1.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution'}, {'id': 'FG002', 'title': '2.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution'}, {'id': 'FG003', 'title': '4.0 mg of DE-122', 'description': 'Single intravitreal injection of High Dose DE-122 Injectable Solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '0.5 mg of DE-122', 'description': 'Single intravitreal injection of Low Dose DE-122 Injectable Solution'}, {'id': 'BG001', 'title': '1.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-Low Dose DE-122 Injectable Solution'}, {'id': 'BG002', 'title': '2.0 mg of DE-122', 'description': 'Single intravitreal injection of Medium-High Dose DE-122 Injectable Solution'}, {'id': 'BG003', 'title': '4.0 mg of DE-122', 'description': 'Single intravitreal injection of High Dose DE-122 Injectable Solution'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.7', 'spread': '4.2', 'groupId': 'BG000'}, {'value': '73.7', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '74.0', 'spread': '6.2', 'groupId': 'BG002'}, {'value': '84.0', 'spread': '7.2', 'groupId': 'BG003'}, {'value': '74.3', 'spread': '8.1', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-30', 'size': 2086976, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-09T16:39', 'hasProtocol': True}, {'date': '2017-08-09', 'size': 982312, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-09T16:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2015-09-13', 'resultsFirstSubmitDate': '2019-10-11', 'studyFirstSubmitQcDate': '2015-09-17', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-10', 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) at Day 90.', 'timeFrame': 'Baseline (Day1) and Day 90.', 'description': 'BCVA measures the acuteness or clearness of best-corrected vision in ETDRS (Early Treatment of Diabetic Retinopathy Study) letters, with a range of \\[0, 97\\] in ETDRS letters.\n\nAn increase in BCVA indicates an improvement in the best corrected vision.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Central Subfield Thickness (CST) at Day 90.', 'timeFrame': 'Baseline (Day1) and Day 90.', 'description': 'Bioactivity measures include CST (μm) measured by SD-OCT. Bioactivity will be considered evident if a considerable decrease in CST is observed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Macular Degeneration'], 'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the safety, tolerability, immunogenicity, and bioactivity of a single intravitreal (IVT) administration of DE-122 in subjects with refractory exudative age-related macular degeneration (AMD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide signed written informed consent\n* Diagnosis of subretinal or intraretinal fluid secondary to exudative age-related macular degeneration\n* Prior treatment in the study eye with any intravitreal anti-VEGF medication\n* At least one lesion in the study eye that meets minimal pathology criteria\n* Best corrected visual acuity of 65 to 20 ETDRS letters in the study eye\n* Best corrected visual acuity of 20/200 or better in the fellow eye\n* Reasonably clear media and some fixation in the study eye\n\nExclusion Criteria:\n\nOcular\n\n* Use or anticipated use of any intravitreal, periocular or photodynamic therapy in the study eye for the treatment of AMD within a specified timeframe prior to Visit 1\n* Uncontrolled or advanced glaucoma, chronic hypotony or vitrectomy in the study eye\n* Evidence of any other ocular disease other than exudative age-related macular degeneration in the study eye that may confound the outcome of the study\n* Need for ocular surgery in the study eye during the course of the study\n* Presence or history of certain ocular or periocular pathology or conditions that could limit the ability to perform required study assessments in either eye and/or confound study results\n\nNon-Ocular\n\n* Allergy or hypersensitivity to study drug product, fluorescein dye or other study-related procedures and medications\n* Current or history of certain systemic conditions, abnormalities or therapies that would render a subject a poor candidate for the study\n* Participation in other investigational drug or device clinical trials within 30 days prior to randomization or planning to participate in other investigational drug or device clinical trials for the duration of the study\n* Females who are pregnant or lactating and females of child-bearing potential who are not using adequate contraceptive precautions and men who do not agree to practice an acceptable method of contraception throughout the course of the study\n* Unable to comply with study procedures or follow-up visits'}, 'identificationModule': {'nctId': 'NCT02555306', 'acronym': 'PAVE', 'briefTitle': 'A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Santen Inc.'}, 'officialTitle': 'A Phase I/II, Open-label, Dose-escalating, Sequential-cohort Study Assessing the Safety, Tolerability, Immunogenicity, and Bioactivity of a Single Intravitreal Injection of DE-122 Injectable Solution for the Treatment of Refractory Exudative Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': '36-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose DE-122', 'description': 'Single intravitreal injection of DE-122 Low Dose Injectable Solution', 'interventionNames': ['Drug: 0.5 mg of DE-122']}, {'type': 'EXPERIMENTAL', 'label': 'Medium-Low Dose DE-122', 'description': 'Single intravitreal injection of DE-122 Medium-Low Dose Injectable Solution', 'interventionNames': ['Drug: 1.0 mg of DE-122']}, {'type': 'EXPERIMENTAL', 'label': 'Medium-High Dose DE-122', 'description': 'Single intravitreal injection of DE-122 Medium-High Dose Injectable Solution', 'interventionNames': ['Drug: 2.0 mg of DE-122']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose DE-122', 'description': 'Single intravitreal injection of DE-122 High Dose Injectable Solution', 'interventionNames': ['Drug: 4.0 mg of DE-122']}], 'interventions': [{'name': '0.5 mg of DE-122', 'type': 'DRUG', 'description': 'DE-122 Injectable Solution', 'armGroupLabels': ['Low Dose DE-122']}, {'name': '1.0 mg of DE-122', 'type': 'DRUG', 'description': 'DE-122 Injectable Solution', 'armGroupLabels': ['Medium-Low Dose DE-122']}, {'name': '2.0 mg of DE-122', 'type': 'DRUG', 'description': 'DE-122 Injectable Solution', 'armGroupLabels': ['Medium-High Dose DE-122']}, {'name': '4.0 mg of DE-122', 'type': 'DRUG', 'description': 'DE-122 Injectable Solution', 'armGroupLabels': ['High Dose DE-122']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '49202', 'city': 'Jackson', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.24587, 'lon': -84.40135}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Santen Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}