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).

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.

Study Overview

• Status: Terminated
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Drug: Active Comparator CT1812; Drug: Placebo Comparator

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85050
      • Phoenix Retina Associates
  • California
    • Sacramento, California, United States, 95825
      • Retinal Consultants Medical Group
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
  • Florida
    • Deerfield Beach, Florida, United States, 33064
      • Rand Eye Institute
    • Deerfield Beach, Florida, United States, 33064
      • Advanced Research
    • Fort Myers, Florida, United States, 11735
      • National Ophthalmic Research Institute
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Retina Specialists
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
  • New Jersey
    • Edison, New Jersey, United States, 08820
      • NJ Retina
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Vitreoretinal Consultants
  • North Carolina
    • Wake Forest, North Carolina, United States, 27587
      • North Carolina Retina Associates
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Verum Research LLC
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Erie Retina Research, LLC
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina, PC
  • Texas
    • Austin, Texas, United States, 78750
      • Austin Clinical Research, LLC
    • Burleson, Texas, United States, 76028
      • Star Vision Consultants
    • Fort Worth, Texas, United States, 76104
      • Texas Retina Associates
    • San Antonio, Texas, United States, 78240
      • Retina Consultants of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo Comparator; 123 participants will receive a single daily dose of placebo
Active Comparator: CT1812 200 mg; Drug: CT1812 Active Study Drug	Drug: Active Comparator CT1812; 123 participants will receive a single daily dose of CT1812 (200 mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye.	Compare the mean rate of growth (slope) in GA lesion area in the study eye measured by fundus autofluorescence imaging (FAF).	Baseline through Week 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and Tolerability of CT1812	Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.	Baseline through Week 104
Plasma concentration of CT1812	Measure pre-dose plasma concentration of CT1812.	Baseline through Week 104

Collaborators and Investigators

• Sponsor: Cognition Therapeutics
• Investigators: Study Director: Anthony Caggiano, Cognition Therapeutics Inc.

Publications and helpful links

Helpful Links

• Magnify Study

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Actual): March 4, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Eye Diseases; Retinal Diseases; Retinal Degeneration; Atrophy; Macular Degeneration; Geographic Atrophy
• Other Study ID Numbers: COG2201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No