Age-Related Macular DegenerationPhase 2NCT05893537
Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
A Phase 2 study testing Active Comparator CT1812 in people with Age-Related Macular Degeneration, run by Cognition Therapeutics at 19 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Active Comparator CT1812
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 19 sitesUnited States
- Study dates
- 16 Jun 2023to 28 Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥50 years at time of informed consent.
- BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at screening.
- Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Austin Clinical Research, LLC
Austin, Texas, 78750
Retina Specialists
Baltimore, Maryland, 21204
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Star Vision Consultants
Burleson, Texas, 76028
Advanced Research
Deerfield Beach, Florida, 33064
Rand Eye Institute
Deerfield Beach, Florida, 33064
NJ Retina
Edison, New Jersey, 08820
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Verum Research LLC
Eugene, Oregon, 97401
National Ophthalmic Research Institute
Fort Myers, Florida, 11735
Texas Retina Associates
Fort Worth, Texas, 76104
Long Island Vitreoretinal Consultants
Great Neck, New York, 11021
Tennessee Retina, PC
Nashville, Tennessee, 37203
Phoenix Retina Associates
Phoenix, Arizona, 85050
Retinal Consultants Medical Group
Sacramento, California, 95825
Retina Consultants of Texas
San Antonio, Texas, 78240
North Carolina Retina Associates
Wake Forest, North Carolina, 27587
Bay Area Retina Associates
Walnut Creek, California, 94598
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
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).
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.
Read the 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).
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Active Comparator CT1812, Placebo Comparator
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Comparator CT1812Drug
123 participants will receive a single daily dose of CT1812 (200 mg)
Placebo ComparatorDrug
123 participants will receive a single daily dose of placebo
| Study group | Role | What they receive |
|---|---|---|
| CT1812 200 mg | Active comparator | Drug: CT1812 Active Study Drug Receives: Drug: Active Comparator CT1812 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline through Week 104
Secondary outcomes (2)
Safety and Tolerability of CT1812
Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.
Measured: Baseline through Week 104
Plasma concentration of CT1812
Measure pre-dose plasma concentration of CT1812.
Measured: Baseline through Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start16 Jun 2023
- Primary completion4 Mar 2025
- Study completion28 Mar 2025
Why it stopped: The trial was closed as part of a strategic business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cognition Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony Caggiano, Study director, Cognition Therapeutics Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893537
- Sponsor's protocol ID
- COG2201
- Status last verified
- Mar 2024
- First submitted
- 17 May 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lizama BN, Reaver A, Look G, Caggiano AO, Hamby ME. Sigma-2 receptor modulators alter low-density lipoprotein receptor-mediated lipid uptake in retinal pigment epithelial cells. Exp Eye Res. 2026 Jun;267:110944. doi: 10.1016/j.exer.2026.110944. Epub 2026 Feb 24.
PubMed 41747884
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05893537
- Acronym / sponsor ID
- COG2201
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was closed as part of a strategic business decision.
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cognition TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT1812 200 mg | Active comparator | Drug: Active Comparator CT1812Drug: CT1812 Active Study Drug |
| Placebo | Placebo comparator | Drug: Placebo ComparatorPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥50 years at time of informed consent.
- BCVA of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts at screening.
- Stable pharmacological treatment of any other chronic conditions for at least 30 days prior to screening.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Comparator CT1812123 participants will receive a single daily dose of CT1812 (200 mg) | Drug | CT1812 200 mg |
| Placebo Comparator123 participants will receive a single daily dose of placebo | Drug | Placebo |
Primary outcome
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).
2 secondary outcomes
Safety and Tolerability of CT1812
Time frame: Baseline through Week 104
Plasma concentration of CT1812
Time frame: Baseline through Week 104
Results and safety
The study was stopped early (reason given: The trial was closed as part of a strategic business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Derived from this study: PubMed 41747884Lizama BN, Reaver A, Look G, Caggiano AO, Hamby ME. Sigma-2 receptor modulators alter low-density lipoprotein receptor-mediated lipid uptake in retinal pigment epithelial cells. Exp Eye Res. 2026 Jun;267:110944. doi: 10.1016/j.exer.2026.110944. Epub 2026 Feb 24.
- Magnify StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Caggiano study director
Cognition Therapeutics Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Active Comparator CT1812 in people with Age-Related Macular Degeneration, run by Cognition Therapeutics at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The trial was closed as part of a strategic business decision.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Geographic Atrophy (GA) lesion area over 104 weeks in the study eye. (time frame: Baseline through Week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05893537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2025.