Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2026-03-09 @ 7:41 AM
Study NCT ID:
NCT05160805
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2021-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-26', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2021-12-06', 'lastUpdatePostDateStruct': {'date': '2024-10-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Tolerability of ONL1204 as assessed by AE reporting and clinical evaluations', 'timeFrame': 'up to 39 weeks', 'description': 'Adverse event reporting, ophthalmic examination to evaluate the anterior and posterior segments of the eye, best-corrected visual acuity, intraocular pressure, electroretinogram, vital signs, clinical laboratory evaluations, and ophthalmic imaging results'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Progressing', 'Glaucoma'], 'conditions': ['Open Angle Glaucoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.onltherapeutics.com/clinical-trials/', 'label': 'ONL Therapeutics corporate website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the safety and tolerability of ONL1204 Ophthalmic Solution in patients with progressing open angle glaucoma.\n\nONL1204 Ophthalmic Solution is a first-in-class inhibitor of fragment apoptosis stimulator (Fas) receptor-mediated cell death that has demonstrated protection of multiple retinal cell types in numerous preclinical models of retinal disease. Apoptosis of retinal ganglion cells is associated with progressive glaucoma. Nonclinical data on ONL1204 Ophthalmic Solution suggest that ONL1204 Ophthalmic Solution may inhibit the cell death pathways in these cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females aged ≥18 years old\n2. Able and willing to give informed consent and attend study visits\n3. Controlled intraocular pressure (IOP) (≤21 mmHg) in both eyes for all previous 3 visits before Screening and at Screening in both eyes\n4. Prior to screening, 3 or more Humphrey Visual Field (HVF) tests (with acceptable reliability standards) or 3 or more Optical Coherence Tomography (OCT) studies of the study eye on record\n5. Open angle glaucoma that is progressing in the study eye\n6. HVF 24-2 at Screening with acceptable reliability standards and MD scores\n\nExclusion Criteria:\n\nConsiderations for either eye\n\n1. Best Corrected Visual Acuity (BCVA) at Screening of ≤64 letters (Snellen equivalent of worse than 20/50)\n2. Severe open angle glaucoma\n3. Glaucoma due to non-open angle causes\n4. Worse than mild non-proliferative diabetic retinopathy\n\n Considerations for study eye:\n5. Visual field results suggestive of another disease (eg, altitudinal field defect)\n6. Evidence of macular edema based on OCT imaging and Investigator's judgement\n7. Previous intravitreal (IVT) injections, history of retinal surgery, history of retinal laser\n8. Cataract surgery within 3 months of Screening or yttrium-aluminum-garnet capsulotomy (YAG) within 4 weeks of Screening\n9. Anticipated need for surgical or procedural intervention for glaucoma, cataract, posterior capsular opacity, refractive error, or retinal conditions during the study\n\n Other general exclusion criteria:\n10. The requirement for oral carbonic anhydrase inhibitors to control intraocular pressure\n11. Severe, unstable, or uncontrolled cardiovascular, diabetic, renal, or pulmonary disease, based on Investigator's judgement\n12. Systolic blood pressure \\>180 mmHg or diastolic blood pressure \\>110 mmHg\n13. Women who are pregnant, breastfeeding, or contemplating pregnancy during the study period and men who are contemplating contributing sperm for a biologic child during the study period\n14. Participation in other ophthalmic clinical trials or use of any other investigational drugs or devices in either eye or systemically for 3 months before Screening (Visit 1)"}, 'identificationModule': {'nctId': 'NCT05160805', 'briefTitle': 'A Phase 1b Study of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'ONL Therapeutics'}, 'officialTitle': 'A Phase 1b Multicenter, Randomized, Single-Masked, Sham-Controlled Study of the Safety and Tolerability of ONL1204 Ophthalmic Solution in Patients with Progressing Open Angle Glaucoma', 'orgStudyIdInfo': {'id': 'ONL1204-OAG-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group A', 'description': 'ONL1204 Ophthalmic solution (Dose A) administered by intravitreal injection', 'interventionNames': ['Drug: ONL1204 Ophthalmic solution (Dose A)']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group B', 'description': 'ONL1204 Ophthalmic solution (Dose B) administered by intravitreal injection', 'interventionNames': ['Drug: ONL1204 Ophthalmic solution (Dose B)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Treatment Group C', 'description': 'Sham procedure without penetrating the eye', 'interventionNames': ['Procedure: Sham procedure']}], 'interventions': [{'name': 'ONL1204 Ophthalmic solution (Dose A)', 'type': 'DRUG', 'description': 'Liquid formulation administered by intravitreal (IVT) injection', 'armGroupLabels': ['Treatment Group A']}, {'name': 'ONL1204 Ophthalmic solution (Dose B)', 'type': 'DRUG', 'description': 'Liquid formulation administered by intravitreal (IVT) injection', 'armGroupLabels': ['Treatment Group B']}, {'name': 'Sham procedure', 'type': 'PROCEDURE', 'description': 'A sham procedure looks like a real injection into the eye but does not penetrate the eye and it does not have any study drug. The procedure is done by touching the eye surface with a syringe without a needle.', 'armGroupLabels': ['Treatment Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2640', 'city': 'Albury', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Albury Eye Clinic Wodonga', 'geoPoint': {'lat': -36.07482, 'lon': 146.92401}}, {'zip': '2220', 'city': 'Hurstville', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Sydney Eye Surgeons', 'geoPoint': {'lat': -33.9677, 'lon': 151.10149}}, {'zip': '2150', 'city': 'Parramatta', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'PersonalEYES', 'geoPoint': {'lat': -33.8178, 'lon': 151.00348}}, {'zip': '2000', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Eye Associates', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'zip': '3143', 'city': 'Armadale', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Armadale Eye Clinic', 'geoPoint': {'lat': -37.85544, 'lon': 145.02052}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Melbourne Eye Specialists', 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3403', 'city': 'Gladstone Park', 'state': 'Victoria', 'country': 'Australia', 'facility': 'North West Eye Specialists', 'geoPoint': {'lat': -37.68742, 'lon': 144.88675}}, {'zip': '3002', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Centre for Eye Research Australia (CERA)', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3150', 'city': 'Waverley', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Waverely Eye Clinic'}, {'zip': '1050', 'city': 'Remuera', 'state': 'Auckland', 'country': 'New Zealand', 'facility': 'Eye Institute Limited', 'geoPoint': {'lat': -36.88041, 'lon': 174.79819}}, {'zip': '6011', 'city': 'Wellington', 'state': 'Wellington Region', 'country': 'New Zealand', 'facility': 'Capital Eye Specialists', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ONL Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}