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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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).

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: Active Comparator CT1812
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥50 years at time of informed consent. BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT1812 200 mg<br>Drug: CT1812 Active Study Drug | Drug: Active Comparator CT1812<br>* 123 participants will receive a single daily dose of CT1812 (200 mg)<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo Comparator<br>* 123 participants will receive a single daily dose of placebo<br>|

What is the study measuring?
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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. | 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 | 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 | Measure pre-dose plasma concentration of CT1812. | Baseline through Week 104 |