A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
- Conditions
- Age-related Macular Degeneration (AMD)Geographic Atrophy (GA)
- Interventions
- Registration Number
- NCT06541704
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
- 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 ≥2.5 mm2 and ≤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
-
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 ≥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 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 ≥ 8.0% during screening as described in the protocol
NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pozelimab + Cemdisiran treatment group Pozelimab Randomized 1:1:1 Pozelimab + Cemdisiran treatment group Cemdisiran Randomized 1:1:1 Cemdisiran monotherapy treatment group Cemdisiran Randomized 1:1:1 Placebo treatment group Placebo Randomized 1:1:1
- Primary Outcome Measures
Name Time Method Growth rate (slope) of total GA lesion area (mm2 /year) measured by Fundus autofluorescence (FAF) From baseline to week 52
- Secondary Outcome Measures
Name Time Method Change in Quantitative contrast sensitivity function (qCSF) From baseline to week 52 and week 104 Growth rate (slope) of total GA lesion area (mm2 /year) measured by FAF From baseline to week 104 Concentrations of total pozelimab in serum Through week 52 and week 104 Change in concentration of total Complement component 5 (C5) From baseline to week 52 and week 104 Incidence of Antidrug antibody (ADA) to pozelimab Through week 52 and week 104 Incidence of ADA to cemdisiran Through week 52 and week 104 Occurrence of Treatment-emergent adverse events (TEAEs) Through week 52, 104 and week 284 Severity of TEAEs Through week 52, 104 and week 284 Change in Low-contrast quantitative visual acuity (LC-qVA) From baseline to week 52 and week 104 Loss of Best corrected visual acuity (BCVA) ≥15 Early treatment diabetic retinopathy study (ETDRS) letters at any 2 consecutive study visits From baseline through week 52 and week 104 Change in Low-luminance low-contrast quantitative visual acuity (LL-LC-qVA) From baseline to week 52 and week 104 Concentrations of total cemdisiran in plasma Through week 52 and week 104 Titer of ADA to pozelimab Through week 52 and week 104 Titer of ADA to cemdisiran Through week 52 and week 104 Incidence of Neutralizing antibody (NAb) to pozelimab Through week 52 and week 104
Trial Locations
- Locations (65)
Associated Retina Consultants
🇺🇸Phoenix, Arizona, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
Salehi Retina Institute dba Retina Associates of Southern California
🇺🇸Huntington Beach, California, United States
South Coast Retina Center
🇺🇸Long Beach, California, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
Retinal Consultants Medical Group Inc Modesto
🇺🇸Modesto, California, United States
California Retina Consultants
🇺🇸Oxnard, California, United States
California Eye Specialists Medical Group Inc.
🇺🇸Pasadena, California, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
Vrmg Inc
🇺🇸Sacramento, California, United States
Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
🇺🇸Sacramento, California, United States
Macula Retina Vitreous Research Institute
🇺🇸Torrance, California, United States
Retina Consultants of Southern Colorado
🇺🇸Colorado Springs, Colorado, United States
Southwest Retina Research Center
🇺🇸Durango, Colorado, United States
Colorado Retina - Lakewood
🇺🇸Lakewood, Colorado, United States
Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
🇺🇸Longmont, Colorado, United States
Retina Group of New England
🇺🇸Waterford, Connecticut, United States
Advanced Research
🇺🇸Coral Springs, Florida, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
🇺🇸Jacksonville, Florida, United States
Florida Retina Institute - Orlando
🇺🇸Orlando, Florida, United States
Retina Vitreous Associates of Florida Saint Petersburg
🇺🇸Saint Petersburg, Florida, United States
Southeast Retina Center
🇺🇸Augusta, Georgia, United States
Georgia Retina - Marietta
🇺🇸Marietta, Georgia, United States
The University of Chicago
🇺🇸Chicago, Illinois, United States
University Retina and Macula Associates PC - Lemont
🇺🇸Lemont, Illinois, United States
Illinois Retina Associates
🇺🇸Oak Park, Illinois, United States
Ross Davis Retina
🇺🇸Metairie, Louisiana, United States
Eye Assoc. of NE LA dba Haik Humble Eye Ctr
🇺🇸West Monroe, Louisiana, United States
Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
🇺🇸West Monroe, Louisiana, United States
Mid Atlantic Retina Specialist
🇺🇸Hagerstown, Maryland, United States
Cumberland Valley Retina Consultants-Ophthalmology
🇺🇸Hagerstown, Maryland, United States
Opthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Mississippi Retina Associates
🇺🇸Madison, Mississippi, United States
Retina Research Institute, LLC
🇺🇸Saint Louis, Missouri, United States
Retina Center of Texas
🇺🇸Southlake, Texas, United States
Retina Vitreous Surgeons of Central New York, PC
🇺🇸Liverpool, New York, United States
Western Carolina Retinal Associates
🇺🇸Asheville, North Carolina, United States
Graystone Eye
🇺🇸Hickory, North Carolina, United States
Piedmont Retina Specialist
🇺🇸Winston-Salem, North Carolina, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Retina Vitreous Center - Edmond
🇺🇸Edmond, Oklahoma, United States
Tulsa Retina Consultants
🇺🇸Tulsa, Oklahoma, United States
Verum Research LLC
🇺🇸Eugene, Oregon, United States
EyeHealth Northwest
🇺🇸Portland, Oregon, United States
Cascade Medical Research Institute LLC
🇺🇸Springfield, Oregon, United States
Erie Retinal Surgery & Erie Retina Research
🇺🇸Erie, Pennsylvania, United States
Sewickley Eye Group
🇺🇸Sewickley, Pennsylvania, United States
Retina Consultants of Carolina
🇺🇸Greenville, South Carolina, United States
Charleston Neuroscience Institute LLC
🇺🇸Ladson, South Carolina, United States
Charleston Neuroscience Institute, LLC
🇺🇸Mount Pleasant, South Carolina, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Tennessee Retina, PC
🇺🇸Nashville, Tennessee, United States
Austin Research Center for Retina
🇺🇸Austin, Texas, United States
Austin Retina Associates
🇺🇸Round Rock, Texas, United States
Retina Consultants Texas
🇺🇸The Woodlands, Texas, United States
Star Retina PLLC
🇺🇸Burleson, Texas, United States
Retina Consultants of Texas
🇺🇸San Antonio, Texas, United States
Valley Retina Institute, P.A.
🇺🇸McAllen, Texas, United States
Retina Consultants of Texas Brown Retina Institute
🇺🇸San Antonio, Texas, United States
Retina Associates Of Utah Retina Specialist
🇺🇸Salt Lake City, Utah, United States
Piedmont Eye Center
🇺🇸Lynchburg, Virginia, United States
Retina Centre of Ottawa - Department of Ophthalmology
🇨🇦Ottawa, Ontario, Canada