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OCU410-101

Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy

View on ClinicalTrials.gov

Quick Information

Age Group
Adult (18-64)
Older adult (65+)
Sex/Gender
All Genders
Accepts Health Volunteers
No
Phase
Phase 1Phase 2
Offered at
Gundersen Health System
Condition(s)
  • Geographic Atrophy
Protocol Number
NCT06018558

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 63 subjects.

Eligibility Criteria

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 or fellow eye

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.

View on ClinicalTrials.gov

1900 South Ave.
La Crosse, WI 54601

(608) 782-7300

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