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

Age-Related Macular Degeneration Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05893537
• Other study ID #: COG2201
• Status: Recruiting
• Phase: Phase 2
• Start date: June 16, 2023
• Est. completion date: August 15, 2027

Study information

• Verified date: March 2024
• Source: Cognition Therapeutics
• Contact: Diana Executive Assistant
• Phone: 888-745-1050
• Email: clinicaltrials[@]cogrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 246
• Est. completion date: August 15, 2027
• Est. primary completion date: July 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Austin Clinical Research, LLC	Austin	Texas
United States	Retina Specialists	Baltimore	Maryland
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Star Vision Consultants	Burleson	Texas
United States	Advanced Research	Coral Springs	Florida
United States	Rand Eye Institute	Deerfield Beach	Florida
United States	NJ Retina	Edison	New Jersey
United States	Erie Retina Research, LLC	Erie	Pennsylvania
United States	Verum Research LLC	Eugene	Oregon
United States	Bay Area Retina Associates	Farmingdale	New York
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Texas Retina Associates	Fort Worth	Texas
United States	Long Island Vitreoretinal Consultants	Great Neck	New York
United States	Tennessee Retina, PC	Nashville	Tennessee
United States	Phoenix Retina Associates	Phoenix	Arizona
United States	Retinal Consultants Medical Group	Sacramento	California
United States	Retina Consultants of Texas	San Antonio	Texas
United States	North Carolina Retina Associates	Wake Forest	North Carolina
United States	Center for Retina and Macular Disease	Winter Haven	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Cognition Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Plasma concentration of CT1812	Measure pre-dose plasma concentration of CT1812.	Baseline through Week 104