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Recruiting Phase 3 NCT06541704

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

Trial Parameters

Condition Age-related Macular Degeneration (AMD)
Sponsor Regeneron Pharmaceuticals
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 975
Sex ALL
Min Age 50 Years
Max Age 85 Years
Start Date 2024-10-30
Completion 2027-11-29
Interventions
PozelimabCemdisiranPlacebo

Brief Summary

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). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead). The purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) are in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Eligibility 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 Neov

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