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

NCT ID: NCT05893537

Last Updated: 2025-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-16

Study Completion Date

2025-03-28

Brief Summary

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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

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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

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT1812 200 mg

Drug: CT1812 Active Study Drug

Group Type ACTIVE_COMPARATOR

Active Comparator CT1812

Intervention Type DRUG

123 participants will receive a single daily dose of CT1812 (200 mg)

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

123 participants will receive a single daily dose of placebo

Interventions

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Active Comparator CT1812

123 participants will receive a single daily dose of CT1812 (200 mg)

Intervention Type DRUG

Placebo Comparator

123 participants will receive a single daily dose of placebo

Intervention Type DRUG

Eligibility Criteria

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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 at screening.
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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cognition Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Caggiano

Role: STUDY_DIRECTOR

Cognition Therapeutics Inc.

Locations

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Phoenix Retina Associates

Phoenix, Arizona, United States

Site Status

Retinal Consultants Medical Group

Sacramento, California, United States

Site Status

Bay Area Retina Associates

Walnut Creek, California, United States

Site Status

Advanced Research

Deerfield Beach, Florida, United States

Site Status

Rand Eye Institute

Deerfield Beach, Florida, United States

Site Status

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Site Status

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Site Status

Retina Specialists

Baltimore, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

NJ Retina

Edison, New Jersey, United States

Site Status

Long Island Vitreoretinal Consultants

Great Neck, New York, United States

Site Status

North Carolina Retina Associates

Wake Forest, North Carolina, United States

Site Status

Verum Research LLC

Eugene, Oregon, United States

Site Status

Erie Retina Research, LLC

Erie, Pennsylvania, United States

Site Status

Tennessee Retina, PC

Nashville, Tennessee, United States

Site Status

Austin Clinical Research, LLC

Austin, Texas, United States

Site Status

Star Vision Consultants

Burleson, Texas, United States

Site Status

Texas Retina Associates

Fort Worth, Texas, United States

Site Status

Retina Consultants of Texas

San Antonio, Texas, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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COG2201

Identifier Type: -

Identifier Source: org_study_id

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