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Trial record 1 of 1 for:    COG2201
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Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).

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ClinicalTrials.gov Identifier: NCT05893537
Recruitment Status : Recruiting
First Posted : June 8, 2023
Last Update Posted : September 6, 2023
Sponsor:
Information provided by (Responsible Party):
Cognition Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Active Comparator CT1812 Drug: Placebo Comparator Phase 2

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 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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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).
Actual Study Start Date : June 16, 2023
Estimated Primary Completion Date : July 15, 2027
Estimated Study Completion Date : August 15, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CT1812 200 mg
Drug: CT1812 Active Study Drug
 Drug: Active Comparator CT1812
123 participants will receive a single daily dose of CT1812 (200 mg)
Placebo Comparator: Placebo
Placebo
 Drug: Placebo Comparator
123 participants will receive a single daily dose of placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye. [ Time Frame: 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 :
  1. Safety and Tolerability of CT1812 [ Time Frame: Baseline through Week 104 ]
    Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.

  2. Plasma concentration of CT1812 [ Time Frame: Baseline through Week 104 ]
    Measure pre-dose plasma concentration of CT1812.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05893537


Contacts
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Contact: Diana Executive Assistant 412-481-2210 clinicaltrials@cogrx.com

Locations
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United States, Florida
Rand Eye Institute Not yet recruiting
Deerfield Beach, Florida, United States, 33064
Principal Investigator: Carl J Danzig, MD         
United States, Pennsylvania
Erie Retina Research, LLC Recruiting
Erie, Pennsylvania, United States, 16507
Contact    814-200-9152    hello@erieretinaresearch.com   
Principal Investigator: David Almeida, MD         
United States, Texas
Austin Clinical Research, LLC Recruiting
Austin, Texas, United States, 78750
Principal Investigator: Brian Berger         
Star Vision Consultants Recruiting
Burleson, Texas, United States, 76028
Principal Investigator: Courtney Crawford, MD         
Texas Retina Associates Recruiting
Fort Worth, Texas, United States, 76104
Principal Investigator: Patrick Williams, MD         
Sponsors and Collaborators
Cognition Therapeutics
Investigators
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Study Director: Anthony Caggiano Cognition Therapeutics Inc.
More Information
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Responsible Party: Cognition Therapeutics
ClinicalTrials.gov Identifier: NCT05893537    
Other Study ID Numbers: COG2201
First Posted: June 8, 2023    Key Record Dates
Last Update Posted: September 6, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Atrophy
Retinal Degeneration
 Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical