Study Stopped
The trial was closed as part of a strategic business decision.
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).
1 other identifier
interventional
100
1 country
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2023
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2023
CompletedFirst Posted
Study publicly available on registry
June 8, 2023
CompletedStudy Start
First participant enrolled
June 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2025
CompletedApril 16, 2025
March 1, 2024
1.7 years
May 17, 2023
April 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Safety and Tolerability of CT1812
Baseline through Week 104
Plasma concentration of CT1812
Baseline through Week 104
Study Arms (2)
CT1812 200 mg
ACTIVE COMPARATORDrug: CT1812 Active Study Drug
Placebo
PLACEBO COMPARATORPlacebo
Interventions
123 participants will receive a single daily dose of CT1812 (200 mg)
Eligibility Criteria
You may qualify if:
- Age ≥50 years at time of informed consent.
- BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at screening.
- Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
You may not qualify if:
- GA due to causes other than dry AMD.
- Any history or current evidence of exudative ("wet") AMD.
- Retinal disease other than dry AMD.
- Any ophthalmologic condition that prevents adequate imaging of the retina as judged by the study site or central reading center.
- Intraocular surgery (including intraocular lens implantation surgery) within 3 months prior to randomization.
- Any ophthalmic condition that will or is likely to require surgery during the study period.
- Hypersensitivity to fluorescein.
- Suspected or known allergy to any components of the study treatments.
- History of vitrectomy surgery, submacular surgery or any other surgical intervention for dry AMD.
- History of glaucoma filtering surgery or corneal transplant in the study eye.
- History of central serous retinopathy in either eye.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Phoenix Retina Associates
Phoenix, Arizona, 85050, United States
Retinal Consultants Medical Group
Sacramento, California, 95825, United States
Bay Area Retina Associates
Walnut Creek, California, 94598, United States
Advanced Research
Deerfield Beach, Florida, 33064, United States
Rand Eye Institute
Deerfield Beach, Florida, 33064, United States
National Ophthalmic Research Institute
Fort Myers, Florida, 11735, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Retina Specialists
Baltimore, Maryland, 21204, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
NJ Retina
Edison, New Jersey, 08820, United States
Long Island Vitreoretinal Consultants
Great Neck, New York, 11021, United States
North Carolina Retina Associates
Wake Forest, North Carolina, 27587, United States
Verum Research LLC
Eugene, Oregon, 97401, United States
Erie Retina Research, LLC
Erie, Pennsylvania, 16507, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Austin Clinical Research, LLC
Austin, Texas, 78750, United States
Star Vision Consultants
Burleson, Texas, 76028, United States
Texas Retina Associates
Fort Worth, Texas, 76104, United States
Retina Consultants of Texas
San Antonio, Texas, 78240, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anthony Caggiano
Cognition Therapeutics Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2023
First Posted
June 8, 2023
Study Start
June 16, 2023
Primary Completion
March 4, 2025
Study Completion
March 28, 2025
Last Updated
April 16, 2025
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share