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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).

Primary Purpose

Age-Related Macular Degeneration

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Active Comparator CT1812
Placebo Comparator
Sponsored by
Cognition Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Retina AssociatesRecruiting
  • Rand Eye InstituteRecruiting
  • National Ophthalmic Research InstituteRecruiting
  • Center for Retina and Macular DiseaseRecruiting
  • Retina SpecialistsRecruiting
  • Bay Area Retina AssociatesRecruiting
  • Verum Research LLCRecruiting
  • Erie Retina Research, LLCRecruiting
  • Tennessee Retina, PCRecruiting
  • Austin Clinical Research, LLCRecruiting
  • Star Vision ConsultantsRecruiting
  • Texas Retina AssociatesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CT1812 200 mg

Placebo

Arm Description

Drug: CT1812 Active Study Drug

Placebo

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Safety and Tolerability of CT1812
Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.
Plasma concentration of CT1812
Measure pre-dose plasma concentration of CT1812.

Full Information

First Posted
May 17, 2023
Last Updated
October 23, 2023
Sponsor
Cognition Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT05893537
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
July 15, 2027 (Anticipated)
Study Completion Date
August 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cognition Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
246 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CT1812 200 mg
Arm Type
Active Comparator
Arm Description
Drug: CT1812 Active Study Drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Active Comparator CT1812
Intervention Description
123 participants will receive a single daily dose of CT1812 (200 mg)
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
123 participants will receive a single daily dose of placebo
Primary Outcome Measure Information:
Title
Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye.
Description
Compare the mean rate of growth (slope) in GA lesion area in the study eye measured by fundus autofluorescence imaging (FAF).
Time Frame
Baseline through Week 104
Secondary Outcome Measure Information:
Title
Safety and Tolerability of CT1812
Description
Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.
Time Frame
Baseline through Week 104
Title
Plasma concentration of CT1812
Description
Measure pre-dose plasma concentration of CT1812.
Time Frame
Baseline through Week 104

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Executive Assistant
Phone
412-481-2210
Email
clinicaltrials@cogrx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Caggiano
Organizational Affiliation
Cognition Therapeutics Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Retina Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danesh Sharam, MD
Facility Name
Rand Eye Institute
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl J Danzig, MD
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
11735
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashish Sharma, MD
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suk Jin Moon, MD
Facility Name
Retina Specialists
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Thompson, MD
Facility Name
Bay Area Retina Associates
City
Farmingdale
State/Province
New York
ZIP/Postal Code
11735
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roger A. Goldberg, MD
Facility Name
Verum Research LLC
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert O. Edwards, PHD
Facility Name
Erie Retina Research, LLC
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
814-200-9152
Email
hello@erieretinaresearch.com
First Name & Middle Initial & Last Name & Degree
David Almeida, MD
Facility Name
Tennessee Retina, PC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric W Schneider, MD
Facility Name
Austin Clinical Research, LLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Berger
Facility Name
Star Vision Consultants
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Crawford, MD
Facility Name
Texas Retina Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Williams, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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