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 |
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Recruitment Status :
Recruiting
First Posted : June 8, 2023
Last Update Posted : March 13, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Age-Related Macular Degeneration | Drug: Active Comparator CT1812 Drug: Placebo Comparator | Phase 2 |
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 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: CT1812 200 mg
Drug: CT1812 Active Study Drug
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Drug: Active Comparator CT1812
123 participants will receive a single daily dose of CT1812 (200 mg) |
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Placebo Comparator: Placebo
Placebo
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Drug: Placebo Comparator
123 participants will receive a single daily dose of placebo |
- 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).
- 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.
- Plasma concentration of CT1812 [ Time Frame: Baseline through Week 104 ]Measure pre-dose plasma concentration of CT1812.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Contact: Diana Executive Assistant | 888-745-1050 | clinicaltrials@cogrx.com |
Show 19 study locations
| Study Director: | Anthony Caggiano | Cognition Therapeutics Inc. |
| Responsible Party: | Cognition Therapeutics |
| ClinicalTrials.gov Identifier: | NCT05893537 |
| Other Study ID Numbers: |
COG2201 |
| First Posted: | June 8, 2023 Key Record Dates |
| Last Update Posted: | March 13, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Macular Degeneration Geographic Atrophy Atrophy Retinal Degeneration |
Retinal Diseases Eye Diseases Pathological Conditions, Anatomical |