Status:
RECRUITING
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Age-related Macular Degeneration (AMD)
Geographic Atrophy (GA)
Eligibility:
All Genders
50-85 years
Phase:
PHASE3
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 (...
Eligibility Criteria
Inclusion
- Key
- Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol
- Total GA area in the study eye measuring between ≥2.5 mm\^2 and ≤17.5 mm\^2 as described in the protocol
- BCVA of 55 letters or better using ETDRS charts (20/80 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
- 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 (MNV) and/or exudation or Peripapillary Choroidal Neovascularization (PPCNV) 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 or anti-VEGF therapy, as long as last dose was ≥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 ≥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 (\>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
- 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
- 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 ≥ 8.0% during screening as described in the protocol
- NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Key Trial Info
Start Date :
October 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 21 2032
Estimated Enrollment :
975 Patients enrolled
Trial Details
Trial ID
NCT06541704
Start Date
October 30 2024
End Date
May 21 2032
Last Update
January 9 2026
Active Locations (139)
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1
Barnet Dulaney Perkins Eye Center
Phoenix, Arizona, United States, 85016
2
Associated Retina Consultants
Phoenix, Arizona, United States, 85020
3
Retinal Research Institute
Phoenix, Arizona, United States, 85053
4
Retina Associates of Tuscan
Tucson, Arizona, United States, 85712