NCT05893537

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

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: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Cognition Therapeutics · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 60 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).

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Active Comparator CT1812	123 participants will receive a single daily dose of CT1812 (200 mg)
DRUG	Placebo Comparator	123 participants will receive a single daily dose of placebo

Timeline

• Start date: 2023-06-16
• Primary completion: 2025-03-04
• Completion: 2025-03-28
• First posted: 2023-06-08
• Last updated: 2025-04-16

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study