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

Last updated: April 11, 2025
Sponsor: Cognition Therapeutics
Overall Status: Terminated

Phase

2

Condition

Macular Degeneration

Myopic Macular Degeneration

Aging

Treatment

Placebo Comparator

Active Comparator CT1812

Clinical Study ID

NCT05893537
COG2201
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 30days prior to screening.

Exclusion

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 judgedby the study site or central reading center.

  5. Intraocular surgery (including intraocular lens implantation surgery) within 3months prior to randomization.

  6. Any ophthalmic condition that will or is likely to require surgery during the studyperiod.

  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 interventionfor dry AMD.

  10. History of glaucoma filtering surgery or corneal transplant in the study eye.

  11. History of central serous retinopathy in either eye.

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo Comparator
Phase: 2
Study Start date:
June 16, 2023
Estimated Completion Date:
March 28, 2025

Study 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).

Connect with a study center

  • Phoenix Retina Associates

    Phoenix, Arizona 85050
    United States

    Site Not Available

  • Retinal Consultants Medical Group

    Sacramento, California 95825
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Advanced Research

    Coral Springs, Florida 33067
    United States

    Site Not Available

  • Advanced Research

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • National Ophthalmic Research Institute

    Fort Myers, Florida 11735
    United States

    Site Not Available

  • Center for Retina and Macular Disease

    Winter Haven, Florida 33880
    United States

    Site Not Available

  • Retina Specialists

    Baltimore, Maryland 21204
    United States

    Site Not Available

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • NJ Retina

    Edison, New Jersey 08820
    United States

    Site Not Available

  • Bay Area Retina Associates

    Farmingdale, New York 11735
    United States

    Site Not Available

  • Long Island Vitreoretinal Consultants

    Great Neck, New York 11021
    United States

    Site Not Available

  • North Carolina Retina Associates

    Wake Forest, North Carolina 27587
    United States

    Site Not Available

  • Verum Research LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Erie Retina Research, LLC

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Tennessee Retina, PC

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Austin Clinical Research, LLC

    Austin, Texas 78750
    United States

    Site Not Available

  • Star Vision Consultants

    Burleson, Texas 76028
    United States

    Site Not Available

  • Texas Retina Associates

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Retina Consultants of Texas

    San Antonio, Texas 78240
    United States

    Site Not Available

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