Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
- Conditions
- Age-Related Macular Degeneration
- Interventions
- Drug: Placebo ComparatorDrug: Active Comparator CT1812
- Registration Number
- NCT05893537
- Lead Sponsor
- Cognition Therapeutics
- 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.
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
- 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.
EXCLUSION CRITERIA:
- 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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Comparator Placebo CT1812 200 mg Active Comparator CT1812 Drug: CT1812 Active Study Drug
- Primary Outcome Measures
Name Time Method Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye. 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).
- Secondary Outcome Measures
Name Time Method Safety and Tolerability of CT1812 Baseline through Week 104 Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.
Plasma concentration of CT1812 Baseline through Week 104 Measure pre-dose plasma concentration of CT1812.
Trial Locations
- Locations (19)
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