Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy (NCT06018558) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
United States60 participantsStarted 2023-02-23
Plain-language 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.
Who can participate
Age range50 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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).
What they're measuring
1
Safety (Participants With Ocular and Non-ocular AEs (Adverse Events) and SAEs (Serious Adverse Events))
Timeframe: 12 months (Screening to 12 months post OCU410 administration)
2
Change in anatomy of ocular structures using Slit Lamp Biomicroscopy
Timeframe: 12 months (Screening to 12 months post OCU410 administration)
3
Change in anatomy of ocular structures using Indirect ophthalmoscopy
Timeframe: 12 months (Screening to 12 months post OCU410 administration)
4
Change from baseline in BCVA (Best Corrected Visual Acuity)
Timeframe: 12 months (Screening to 12 months post OCU410 administration)
5
Change in Low Luminance Visual Acuity
Timeframe: 12 months (Screening to 12 months post OCU410 administration)
6
Change in the Intraocular Pressure (mmHg)
Timeframe: 12 months (Screening to 12 months post OCU410 administration)
. 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.