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Investigating a new treatment for geographic atrophy in age-related macular degeneration

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

PHASE3 · Regeneron Pharmaceuticals · NCT06541704

This study is testing a new treatment using two drugs to see if they can slow down the worsening of geographic atrophy in adults with age-related macular degeneration.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment975 (estimated)
Ages50 Years to 85 Years
SexAll
SponsorRegeneron Pharmaceuticals (industry)
Drugs / interventionsprednisone, pozelimab
Locations216 sites (Chandler, Arizona and 215 other locations)
Trial IDNCT06541704 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of pozelimab and cemdisiran, either alone or in combination, on the progression of geographic atrophy (GA) in adults with age-related macular degeneration (AMD). Participants will receive either the study drugs or a placebo, and the study will monitor the progression of GA, side effects, drug levels in the blood, and the body's immune response to the drugs. The goal is to determine the efficacy and safety of these treatments in slowing down GA progression.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with geographic atrophy secondary to age-related macular degeneration, with specific visual acuity and GA area criteria.

Not a fit: Patients with geographic atrophy caused by conditions other than AMD or those with macular neovascularization may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that slows the progression of geographic atrophy in patients with AMD.

How similar studies have performed: Other studies have explored treatments for geographic atrophy, but the specific combination of pozelimab and cemdisiran is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
2. Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
3. BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol

Key Exclusion Criteria:

1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
2. History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol
3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization
4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization
5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study
6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol

   Systemic Exclusion criteria
7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
8. History of solid organ or bone marrow transplantation
9. Use of chronic (\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol
10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol
11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
12. Carrier of Neisseria meningitidis based on culture collected during screening
13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol

NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Where this trial is running

Chandler, Arizona and 215 other locations

+166 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Age-related Macular Degeneration, Geographic Atrophy, GA secondary to AMD

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.