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

March 12, 2024 updated by: Cognition Therapeutics

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

Recruiting

Conditions

Intervention / Treatment

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 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).

Study Type

Interventional

Enrollment (Estimated)

246

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
        • Recruiting
        • Phoenix Retina Associates
        • Principal Investigator:
          • Danesh Sharam, MD
    • California
      • Sacramento, California, United States, 95825
        • Recruiting
        • Retinal Consultants Medical Group
        • Principal Investigator:
          • Joel Pearlman, PhD
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Recruiting
        • Advanced Research
        • Principal Investigator:
          • Shailesh Gupta, MD
      • Deerfield Beach, Florida, United States, 33064
        • Recruiting
        • Rand Eye Institute
        • Principal Investigator:
          • Carl J Danzig, MD
      • Fort Myers, Florida, United States, 11735
        • Recruiting
        • National Ophthalmic Research Institute
        • Principal Investigator:
          • Ashish Sharma, MD
      • Winter Haven, Florida, United States, 33880
        • Recruiting
        • Center for Retina and Macular Disease
        • Principal Investigator:
          • Suk Jin Moon, MD
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Recruiting
        • Retina Specialists
        • Principal Investigator:
          • John Thompson, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Ophthalmic Consultants of Boston
        • Principal Investigator:
          • Jeffrey S. Heier, MD
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • Recruiting
        • NJ Retina
        • Principal Investigator:
          • Howard Fine, MD
    • New York
      • Farmingdale, New York, United States, 11735
        • Recruiting
        • Bay Area Retina Associates
        • Principal Investigator:
          • Roger A. Goldberg, MD
      • Great Neck, New York, United States, 11021
        • Recruiting
        • Long Island Vitreoretinal Consultants
        • Principal Investigator:
          • Philip J Ferrone, MD
    • North Carolina
      • Wake Forest, North Carolina, United States, 27587
        • Recruiting
        • North Carolina Retina Associates
        • Principal Investigator:
          • John E. Thordsen, MD
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Verum Research LLC
        • Principal Investigator:
          • Albert O. Edwards, PHD
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Recruiting
        • Erie Retina Research, LLC
        • Contact:
        • Principal Investigator:
          • David Almeida, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Tennessee Retina, PC
        • Principal Investigator:
          • Eric W Schneider, MD
    • Texas
      • Austin, Texas, United States, 78750
        • Recruiting
        • Austin Clinical Research, LLC
        • Principal Investigator:
          • Brian Berger
      • Burleson, Texas, United States, 76028
        • Recruiting
        • Star Vision Consultants
        • Principal Investigator:
          • Courtney Crawford, MD
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Texas Retina Associates
        • Principal Investigator:
          • Patrick Williams, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Retina Consultants of Texas
        • Principal Investigator:
          • Sarah E Holy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: Baseline through Week 104
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
Time Frame: Baseline through Week 104
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
Time Frame: Baseline through Week 104
Measure pre-dose plasma concentration of CT1812.
Baseline through Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cognition Therapeutics

Investigators

  • Study Director: Anthony Caggiano, Cognition Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2023

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

August 15, 2027

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)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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