What is this study of pozelimab and cemdisiran trying to find out about Geographic Atrophy?

This study is evaluating how these experimental drugs affect the progression of Geographic Atrophy caused by Age-related Macular Degeneration. Researchers also want to understand potential side effects, drug levels in the blood, and whether the body produces antibodies that might influence treatment. Regeneron Pharmaceuticals is leading this research to explore new options for managing this eye condition.

Who may be eligible for this Geographic Atrophy clinical trial?

Adults aged 50 to 85 years with a diagnosis of Geographic Atrophy due to Age-related Macular Degeneration may be eligible. Participants must have a certain range of lesion size and good vision in the study eye. They also need to complete specific vaccinations and have no recent eye treatments that would conflict. Please review eligibility criteria for more details.

Is there any cost to participate in this Geographic Atrophy clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants should consider their own travel arrangements when joining the trial.

Actively Recruiting

Phase 3

Age: 50Years - 85Years

All Genders

ID06541704

A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of Subcutaneously Administered Pozelimab With or Without Cemdisiran in Adults With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Led by Regeneron Pharmaceuticals · Updated on 2026-05-27

975

Participants Needed

216

Research Sites

233 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of experimental drugs called pozelimab and cemdisiran on people with Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The trial aims to compare the rate at which GA progresses in patients receiving cemdisiran alone, pozelimab combined with cemdisiran, or a placebo. The study also explores possible side effects, how much of the drugs remain in the blood over time, and whether the body develops antibodies that might impact treatment. Participants are randomly assigned to one of three groups one receiving both pozelimab and cemdisiran, one receiving cemdisiran alone, and one receiving a placebo. All treatments are given by subcutaneous injection. The study is conducted in a double-masked manner to ensure unbiased results. Vaccinations against meningococcal and pneumococcal infections are required before participation. During the study, participants will attend regular clinic visits where eye imaging and vision tests will be performed to monitor the size of GA lesions and changes in visual acuity. Blood samples will be taken to measure drug levels and antibody development. The primary outcome is the growth rate of GA lesion area over 52 weeks. Safety will be monitored throughout and up to nearly six years. The overall study duration allows detailed assessment of treatment effects and tolerability.

CONDITIONS

Brief Title

A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy

Who Can Participate

Age: 50Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Study eye diagnosed with Geographic Atrophy secondary to Age-related Macular Degeneration
Total Geographic Atrophy area in study eye between 2.5 mm² and 17.5 mm²
Best Corrected Visual Acuity (BCVA) of 55 letters or better using ETDRS charts (20/80 Snellen equivalent) in the study eye
Clear ocular media, adequate pupil dilation, and fixation for quality fundus imaging in the study eye
Willing and able to comply with clinic visits and study procedures, including completing required meningococcal and pneumococcal vaccinations

You will not qualify if you...

Geographic Atrophy caused by conditions other than Age-related Macular Degeneration (e.g., Stargardt disease, cone rod dystrophy, hydroxychloroquine maculopathy)
History or current evidence of Macular Neovascularization or Peripapillary Choroidal Neovascularization in either eye
Prior or current intravitreal treatment in either eye within 6 months before randomization, except approved or investigational complement inhibitor or anti-VEGF therapies
Prior intraocular surgery in study eye within 3 months before randomization, except cataract extraction or minimally invasive glaucoma surgery
Progressive eye conditions affecting central vision in study eye (e.g., diabetic retinopathy, macular edema, uncontrolled glaucoma, macular hole)
Ophthalmologic conditions reducing media clarity that interfere with eye examination (e.g., advanced cataract, corneal abnormalities)
Use of systemic complement inhibitor therapy within 6 months before randomization
History of solid organ or bone marrow transplantation
Use of chronic systemic corticosteroids (>14 days, ≥20 mg prednisone or equivalent) within 30 days prior to screening
Use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or planned during study
Not meeting meningococcal or pneumococcal vaccination requirements
Carrier of Neisseria meningitidis based on screening culture
Hemoglobin A1C of 8.0% or higher during screening

Research Team

Clinical Trials Administrator

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