RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Pozelimab for Age-related Macular Degeneration (AMD)

This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD).

Official registry: https://clinicaltrials.gov/study/NCT06541704 · Regeneron Pharmaceuticals · enrollment listed as 975

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Pozelimab, Cemdisiran, or Placebo. The registry lists allocation as randomized. This study is researching experimental (study) drugs called pozelimab and cemdisiran.

They plan to enroll about 975 people at 233 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Pozelimab, Cemdisiran, Placebo

Primary outcome (registry wording): Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF)

Who it is for (from inclusion criteria)

Ages 50 Years to 85 Years
Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
BCVA of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye as described in the protocol
Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol
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

Who the registry excludes

GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy
History or current evidence of Macular Neovascularization (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol
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
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
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
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

Public study contact (from the registry)

Clinical Trials Administrator

844-734-6643

clinicaltrials@regeneron.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

233 listed

Barnet Dulaney Perkins Eye Center-Ophthamalogy — Chandler, Arizona (recruiting)
Barnet Dulaney Perkins Eye Center — Phoenix, Arizona (recruiting)
Associated Retina Consultants — Phoenix, Arizona (recruiting)
Retinal Research Institute — Phoenix, Arizona (recruiting)
Retina Macula Institute of Arizona — Scottsdale, Arizona (recruiting)
Retina Associates of Tuscan — Tucson, Arizona (recruiting)
Retina Partners of Northwest Arkansas, PLLC — Springdale, Arkansas (recruiting)
Retina Vitreous Associates Medical Group — Beverly Hills, California (recruiting)
Retina Specialists of Beverly Hills- Department of Ophthalmology — Beverly Hills, California (recruiting)
The Retina Partners — Encino, California (completed)
Eye Medical Center of Fresno — Fresno, California (recruiting)
Retina Consultants of Orange County — Fullerton, California (completed)

+ 73 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06541704 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06541704?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06541704?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary