Age-Related Macular Degeneration
Conditions
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).
Interventions
DRUGActive Comparator CT1812
123 participants will receive a single daily dose of CT1812 (200 mg)
DRUGPlacebo Comparator
123 participants will receive a single daily dose of placebo
Sponsors
Cognition Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed