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

Launched by REGENERON PHARMACEUTICALS · Aug 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two study drugs, pozelimab and cemdisiran, to see how well they can slow down the progression of geographic atrophy (GA), a serious eye condition caused by age-related macular degeneration (AMD). Participants in the study will be adults who have GA affecting their central vision, and they will receive either cemdisiran alone, a combination of both drugs, or a placebo (a harmless substance with no active ingredients). The study aims to understand how these treatments affect the growth of GA, any possible side effects, and how the body responds to the drugs.

To join the study, participants must be adults with a specific type of GA in one eye and meet certain health criteria, like having a clear view of the eye during exams. Throughout the trial, participants will have regular clinic visits to monitor their health and the effects of the treatments. It's important to note that those with other eye conditions or certain medical histories may not be eligible. Overall, this study hopes to provide valuable information that could help in treating GA in the future.

Gender

ALL

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 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