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
Regeneron Pharmaceuticals
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
- Age range
- 50–85 years
- Sex
- All
- Healthy volunteers
- No
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 comp…
Interventions
- DrugPozelimab
Subcutaneous (SC) injection
- DrugCemdisiran
SC injection
- DrugPlacebo
SC injection
Locations (216)
- Barnet Dulaney Perkins Eye Center-OphthamalogyChandler, Arizona
- Barnet Dulaney Perkins Eye CenterPhoenix, Arizona
- Associated Retina ConsultantsPhoenix, Arizona
- Retinal Research InstitutePhoenix, Arizona
- Retina Macula Institute of ArizonaScottsdale, Arizona
- Retina Associates of TuscanTucson, Arizona