Status:
ACTIVE_NOT_RECRUITING
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Lead Sponsor:
Ocugen
Conditions:
Geographic Atrophy
Eligibility:
All Genders
50+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a Phase 1/2 Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (AMD). This is a multicenter study, which will be conduc...
Detailed Description
Name of Sponsor/Company: Ocugen, Inc. 11 Great Valley Parkway Malvern, PA 19355 Name of Investigational Product: OCU410 Name of Active Ingredient: Adeno-associated viral vector 5 human RORA (AAV5-...
Eligibility Criteria
Inclusion
- Subjects 50 years of age or older.
- BCVA of approximately 21 letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen equivalent).
- Fundus autofluorescence (FAF) imaging shows:
- Total GA area ≥2.0 and ≤20.5 mm2 (1 and 8 disk areas \[DA\], respectively)
- If GA is multifocal, at least one focal lesion must be ≥1.25 mm2 (0.5 DA), with the overall aggregate area of GA as specified above in 3.a
- The entire GA lesion must be completely visualized on the macula-centered image and must be able to be imaged in its entirety, and not contiguous with any areas of peripapillary atrophy
- Presence of any pattern of hyper-autofluorescence in the junctional zone of GA
- Subjects who had prior treatment with an approved drug for AMD, e.g. Izerway® (Avacincaptad pegol) or Syfovre® (Pegcetacoplan injection) can be included, after a washout period of at least 3 months in study eye. Subjects can receive an approved drug for AMD in the fellow eye, if required.
Exclusion
- Previous treatment with a gene-therapy or cell therapy product
- GA due to causes other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Plaquenil maculopathy. However, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., pavingstone degeneration).
- Spherical equivalent of the refractive error demonstrating \> 6 diopters of myopia or an axial length \>26 mm, inability to fixate, uncontrolled glaucoma, advanced cataract, corneal abnormalities, medium haze, and other retinal pathologies.
- Any history or current evidence of exudative ("wet") AMD including any evidence of retinal pigment epithelium rips, branch retinal artery or vein occlusion, corneal transplant, or evidence of neovascularization anywhere in the retina based on fluorescein angiogram.
Key Trial Info
Start Date :
February 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06018558
Start Date
February 23 2023
End Date
May 29 2026
Last Update
December 5 2025
Active Locations (12)
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1
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
2
Advanced Research, LLC
Coral Springs, Florida, United States, 33067
3
Miidwest Eye Institute
Carmel, Indiana, United States, 46290
4
Mississippi Retina Associates
Jackson, Mississippi, United States, 39202