Clinical trial NCT05893537: Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
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).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Lead sponsor: Cognition Therapeutics
Sponsor class: INDUSTRY
First posted: 2023-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye.
timeFrame: Baseline through Week 104
Secondary outcomes:
measure: Safety and Tolerability of CT1812
timeFrame: Baseline through Week 104
measure: Plasma concentration of CT1812
timeFrame: Baseline through Week 104
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Retina Associates
state: Arizona
city: Sacramento
country: United States
facility: Retinal Consultants Medical Group
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Deerfield Beach
country: United States
facility: Advanced Research
state: Florida
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Fort Myers
country: United States
facility: National Ophthalmic Research Institute
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Baltimore
country: United States
facility: Retina Specialists
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Edison
country: United States
facility: NJ Retina
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: Wake Forest
country: United States
facility: North Carolina Retina Associates
state: North Carolina
city: Eugene
country: United States
facility: Verum Research LLC
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research, LLC
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Austin
country: United States
facility: Austin Clinical Research, LLC
state: Texas
city: Burleson
country: United States
facility: Star Vision Consultants
state: Texas
city: Fort Worth
country: United States
facility: Texas Retina Associates
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
affiliation: Cognition Therapeutics Inc.
name: Anthony Caggiano
role: STUDY_DIRECTOR
References: