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

Cognition Therapeutics

Status and phase: Enrolling; Phase 2

Conditions: Age-Related Macular Degeneration

Treatments: Drug: Active Comparator CT1812; Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT05893537

COG2201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 246 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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246 participants in 2 patient groups, including a placebo group

CT1812 200 mg

Active Comparator group

Description:

Drug: CT1812 Active Study Drug

Treatment:

Drug: Active Comparator CT1812

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo Comparator