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
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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TERMINATED
PHASE2
100 participants
INTERVENTIONAL
2023-06-16
2025-03-28
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CT1812 200 mg
Drug: CT1812 Active Study Drug
Active Comparator CT1812
123 participants will receive a single daily dose of CT1812 (200 mg)
Placebo
Placebo
Placebo Comparator
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)
Placebo Comparator
123 participants will receive a single daily dose of placebo
Eligibility Criteria
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Inclusion Criteria
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
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.
50 Years
ALL
No
Sponsors
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Cognition Therapeutics
INDUSTRY
Responsible Party
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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
Retinal Consultants Medical Group
Sacramento, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Advanced Research
Deerfield Beach, Florida, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Retina Specialists
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
NJ Retina
Edison, New Jersey, United States
Long Island Vitreoretinal Consultants
Great Neck, New York, United States
North Carolina Retina Associates
Wake Forest, North Carolina, United States
Verum Research LLC
Eugene, Oregon, United States
Erie Retina Research, LLC
Erie, Pennsylvania, United States
Tennessee Retina, PC
Nashville, Tennessee, United States
Austin Clinical Research, LLC
Austin, Texas, United States
Star Vision Consultants
Burleson, Texas, United States
Texas Retina Associates
Fort Worth, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
Countries
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Related Links
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Magnify Study
Other Identifiers
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COG2201
Identifier Type: -
Identifier Source: org_study_id
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