A Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Phase 2 Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

COG2201

This is a Phase 2, prospective, multicenter, randomized, double-masked, placebo-controlled 104-week study to assess the efficacy, safety, and tolerability of orally delivered CT1812 compared to placebo in participants with GA associated with dry AMD.

2023-06-16

2027-07-15

2027-08-15

Recruiting

Early phase I

246

Inclusion Criteria: 1. Age ≥50 years at time of informed consent. 2. BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. 3. Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening. EXCLUSION CRITERIA: 1. GA due to causes other than dry AMD. 2. Any history or current evidence of exudative ("wet") AMD. 3. Retinal disease other than dry AMD. 4. Any ophthalmologic condition that prevents adequate imaging of the retina as judged by the study site or central reading center. 5. Intraocular surgery (including intraocular lens implantation surgery) within 3 months prior to randomization. 6. Any ophthalmic condition that will or is likely to require surgery during the study period. 7. Hypersensitivity to fluorescein. 8. Suspected or known allergy to any components of the study treatments. 9. History of vitrectomy surgery, submacular surgery or any other surgical intervention for dry AMD. 10. History of glaucoma filtering surgery or corneal transplant in the study eye. 11. History of central serous retinopathy in either eye.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 246, 'type': 'ESTIMATED'}}

2024-03-13