Clinical Trials in the USA / NCT06018558
Active, not recruiting
Phase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
NCT06018558 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Geographic Atrophy
Investigational drug(s) / intervention(s)
OCU410
OCU410: Subretinal administration of OCU410
Study 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 conducted in two phases and will enroll up to a total of 60 subjects.
Eligibility
Inclusion Criteria:
1. Subjects 50 years of age or older.
2. BCVA of approximately 21 letters or more using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (20/320 Snellen equivalent).
3. Fundus autofluorescence (FAF) imaging shows:
1. Total GA area ≥2.0 and ≤20.5 mm2 (1 and 8 disk areas \[DA\], respectively)
2. 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
3. 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
4. Presence of any pattern of hyper-autofluorescence in the junctional zone of GA
4. 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 Criteria:
1. Previous treatment with a gene-therapy or cell therapy product
2. 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).
3. 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.
4. 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.
Primary outcome measure(s)
- Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events)) — 12 months (Screening to 12 months post OCU410 administration)
The primary endpoint is safety, determined by the number of ocular and non-ocular Study Drug-related adverse events (SDAE), treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). - Change in anatomy of ocular structures using Slit Lamp Biomicroscopy — 12 months (Screening to 12 months post OCU410 administration)
We will use Slit-lamp Biomicroscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits. - Change in anatomy of ocular structures using Indirect ophthalmoscopy — 12 months (Screening to 12 months post OCU410 administration)
We will use Indirect ophthalmoscopy to visualize the anatomy of ocular structures before and after sub-retinal injections and follow-up visits. - Change from baseline in BCVA (Best Corrected Visual Acuity) — 12 months (Screening to 12 months post OCU410 administration)
Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. A higher score represents better vision. - Change in Low Luminance Visual Acuity — 12 months (Screening to 12 months post OCU410 administration)
Measured by letter score. A higher score represents better vision - Change in the Intraocular Pressure (mmHg) — 12 months (Screening to 12 months post OCU410 administration)
Measured by applanation or rebound tonometry with confirmation with Goldmann tonometer if IOP is outside normal range (8-21mmHg).
Trial sites (12)
| Facility | City | Region | Status |
|---|---|---|---|
| Associated Retina Consultants | Phoenix | Arizona | |
| Advanced Research, LLC | Coral Springs | Florida | |
| Miidwest Eye Institute | Carmel | Indiana | |
| Mississippi Retina Associates | Jackson | Mississippi | |
| The Retina Institute | St Louis | Missouri | |
| Mid Atlantic Retina | Cherry Hill | New Jersey | |
| Duke Eye Center | Durham | North Carolina | |
| The University of Pittsburgh | Pittsburgh | Pennsylvania | |
| B) Retina Consultants of Texas | Bellaire | Texas | |
| A) Retina Foundation of the Southwest | Dallas | Texas | |
| Valley retina Institute | McAllen | Texas | |
| Gundersen Health System | La Crosse | Wisconsin |
More Ocugen trials in the USA
A Phase 3 Study Of OCU400 Gene Therapy for the Treatment Of Retinitis Pigmentosa
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Study to Assess the Safety and Efficacy of OCU400 for Retinitis Pigmentosa and Leber Congenital Amaurosis
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A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease
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Other trials for the same condition
Phase 3, Randomized, Placebo-Controlled Study of Tinlarebant to Explore Safety and Efficacy in Geographic Atrophy
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06018558 on ClinicalTrials.gov ↗ ← All trials in the USA