Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

Age-Related Macular Degeneration Clinical Trial

Official title: 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).

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. Participants ≥50 years old diagnosed with GA secondary to dry AMD and who meet all inclusion criteria and none of the exclusion criteria will be included in the study. The study will randomize up to 246 participants in a 1:1 manner (123 participants per treatment group) to receive a single daily dose of either CT1812 (200 mg) or placebo across approximately 40-50 sites. Following a screening period of up to 28 days, the total expected duration of participant participation in the study will be 108 weeks (104-week treatment period followed by a 28-day [4-week] post treatment safety follow up period). ;

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

• NCT number: NCT05893537
• Study type: Interventional
• Source: Cognition Therapeutics
• Contact: Diana Executive Assistant
• Phone: 888-745-1050
• Email: clinicaltrials@cogrx.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 16, 2023
• Completion date: August 15, 2027