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
Eligibility
You can join if...
Key Inclusion Criteria:
Study eye with diagnosis of GA of the macula secondary to AMD not involving the foveal center point as described in the protocol
Total GA area in the study eye measuring between greater than or equal to 2.5 mm2 and less than or equal to 17.5 mm2 as described in the protocol
BCVA of 35 letters or better using ETDRS charts (20/200 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
Key Exclusion Criteria:
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 and/or exudation 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 as long as last dose was greater than or equal to 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 greater than or equal to 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
Systemic Exclusion criteria
History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol
History of solid organ or bone marrow transplantation
Use of chronic (greater than 14 days) systemic corticosteroids (oral or parenteral, greater than or equal to 20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol
Current or prior use of systemic immunosuppressive therapy other than corticosteroids or the likelihood of treatment with any such agent during the study inclusive of the screening period
Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol
Carrier of Neisseria meningitidis based on culture collected during screening
Has a hemoglobin A1C greater than or equal to 8.0% during screening as described in the protocol
NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply