ClinicalTrials.gg
TerminatedNCT05893537Updated Apr 16, 2025

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 interventional study of Active Comparator CT1812 and Placebo Comparator in Age-Related Macular Degeneration, sponsored by Cognition Therapeutics. Terminated at 19 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-04-16.

Sponsored by Cognition Therapeutics · Phase 2, Interventional, and Treatment

Why this study was terminated
The trial was closed as part of a strategic business decision.

From the registry’s dates

  • Primary completion was Mar 2025, 1 year 8 months ago, and no results have been posted to the registry.

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Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 645 studies in Macular Degeneration with a site in United States — 84 open to participants now, 128 under way, 24 of them phase 3. Macular Degeneration · United States.

Enrollment
176th of 491
100 · median 55
Started
2023
with 23 others
Phase 2
138 of 645
14 open now
Registered
543rd of 645
by date

Among the 645 studies in Macular Degeneration with a site in United States, this one is the 176th largest by enrollment of the 491 interventional ones that give a count, is one of 24 that started in 2023, is one of 138 in phase 2, and was the 543rd registered.

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 236 are open to participants now.

Browse Macular Degeneration studies →

Open to participants now

84 of the 645 studies in Macular Degeneration with a site in United States are open now. Recruiting first, the newest first:

79 more — sign in →

All 84 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 165 Macular Degeneration studies recruiting now, 116 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.

This study: 50 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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).

03

Conditions studied

  • Age-Related Macular Degeneration
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥50 years at time of .
  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

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. 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Active comparator
    CT1812 200 mg

    Drug: CT1812 Active Study Drug

    Drug: Active Comparator CT1812

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo Comparator

Interventions

  • DrugActive Comparator CT1812

    123 participants will receive a single daily dose of CT1812 (200 mg)

  • DrugPlacebo Comparator

    123 participants will receive a single daily dose of placebo

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline through Week 104

Secondary outcomes

  1. Safety and Tolerability of CT1812

    Incidence and Severity of Adverse Events compared to placebo in participants with GA secondary to dry AMD.

    Time frame: Baseline through Week 104

  2. Plasma concentration of CT1812

    Measure pre-dose plasma concentration of CT1812.

    Time frame: Baseline through Week 104

07

Study locations

19 sites
  • Phoenix Retina Associates
    Phoenix, Arizona 85050, United States
  • Retinal Consultants Medical Group
    Sacramento, California 95825, United States
  • Bay Area Retina Associates
    Walnut Creek, California 94598, United States
  • Advanced Research
    Deerfield Beach, Florida 33064, United States
  • Rand Eye Institute
    Deerfield Beach, Florida 33064, United States
  • National Ophthalmic Research Institute
    Fort Myers, Florida 11735, United States
  • Center for Retina and Macular Disease
    Winter Haven, Florida 33880, United States
  • Retina Specialists
    Baltimore, Maryland 21204, United States
  • Ophthalmic Consultants of Boston
    Boston, Massachusetts 02114, United States
  • NJ Retina
    Edison, New Jersey 08820, United States
  • Long Island Vitreoretinal Consultants
    Great Neck, New York 11021, United States
  • North Carolina Retina Associates
    Wake Forest, North Carolina 27587, United States
  • Verum Research LLC
    Eugene, Oregon 97401, United States
  • Erie Retina Research, LLC
    Erie, Pennsylvania 16507, United States
  • Tennessee Retina, PC
    Nashville, Tennessee 37203, United States
  • Austin Clinical Research, LLC
    Austin, Texas 78750, United States
  • Star Vision Consultants
    Burleson, Texas 76028, United States
  • Texas Retina Associates
    Fort Worth, Texas 76104, United States
  • Retina Consultants of Texas
    San Antonio, Texas 78240, United States
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2023 to primary completion in Mar 2025, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 17, 2023
First posted
Jun 8, 2023
StartActual
Jun 16, 2023
Primary completionActual
Mar 4, 2025
CompletionActual
Mar 28, 2025
Last update
Apr 16, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05893537
Lead sponsor
Cognition Therapeutics
Responsible party
Sponsor
First posted
Jun 8, 2023
Start date
Jun 16, 2023
Primary completion
Mar 4, 2025
Completion
Mar 28, 2025
Last update
Apr 16, 2025

Study contacts

Anthony Caggiano
study director · Cognition Therapeutics Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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