Home › Macular Degeneration › NCT06541704
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
RecruitingPhase 3
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
Who can join
Ages 50 to 85 · All sexes
Full 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
About the study
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)
What is being tested
- Pozelimab (drug)
- Cemdisiran (drug)
- Placebo (drug)
Sponsor: Regeneron Pharmaceuticals · Participants: 975 · Started: Oct 30, 2024
Contact the study team
Official record on ClinicalTrials.gov — NCT06541704
Locations in the U.S.
| Arizona | Barnet Dulaney Perkins Eye Center-Ophthamalogy, Chandler Associated Retina Consultants, Phoenix Barnet Dulaney Perkins Eye Center, Phoenix Retinal Research Institute, Phoenix Retina Macula Institute of Arizona, Scottsdale Retina Associates of Tuscan, Tucson |
| Arkansas | Retina Partners of Northwest Arkansas, PLLC, Springdale |
| California | Retina Specialists of Beverly Hills- Department of Ophthalmology, Beverly Hills Retina Vitreous Associates Medical Group, Beverly Hills Eye Medical Center of Fresno, Fresno Salehi Retina Institute dba Retina Associates of Southern California, Huntington Beach University of California Irvine, Irvine University of California San Diego, Jacobs Retina Center, La Jolla South Coast Retina Center, Long Beach Jules Stein Eye Institute in David Geffen School of Medicine at UCLA, Los Angeles Kaiser Permanente Los Angeles Medical Center, Los Angeles Retinal Consultants Medical Group Inc Modesto, Modesto Northern California Retina Vitreous Associates Medical Group, Inc., Mountain View California Retina Consultants, Oxnard California Eye Specialists Medical Group Inc., Pasadena Retina Consultants San Diego, Poway California Eye Specialists Medical Group, Inc., Redlands Optic Eye Care, Rowland Heights Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center, Sacramento UC Davis Health Eye Center, Sacramento Vrmg Inc, Sacramento West Coast Retina Medical Group, Inc., San Francisco Orange County Retina Medical Group, Santa Ana Macula Retina Vitreous Research Institute, Torrance |
| Colorado | University of Colorado, Aurora Retina Consultants of Southern Colorado, Colorado Springs Retina Specialists of Colorado - Denver, Denver Southwest Retina Research Center, Durango Colorado Retina - Lakewood, Lakewood Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute, Longmont |
| Florida | Advanced Retina Institute-Ophthalmology, Bonita Springs Advanced Research, Coral Springs Retina Group of Florida, Fort Lauderdale ClearVista Clinical Research, Retina Center Tampa Bay, Hudson Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology, Jacksonville Florida Retina Consultants, Lakeland Bascom Palmer Eye Institute, Naples Florida Retina Institute - Orlando, Orlando Retina Care Specialists, Palm Beach Gardens Eye Associates of Pinellas, Pinellas Park Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology, Sarasota Retina Vitreous Associates of Florida Saint Petersburg, St. Petersburg University of South Florida Ophthalmology, Tampa Center for Retina and Macular Disease, Winter Haven |
| Georgia | Southeast Retina Center, Augusta Georgia Retina - Marietta, Marietta |
| Illinois | Retinal Vitreal Consultants, Chicago The University of Chicago, Chicago University of Illinois at Chicago, Chicago University Retina and Macula Associates PC - Lemont, Lemont Illinois Retina Associates, Oak Park Springfield Clinic Main Campus East, Springfield |
| Kansas | Retina Associates, LLC, Lenexa |
| Kentucky | University of Louisville, Louisville |
| Louisiana | Retina Associate New Orleans, Metairie Ross Davis Retina, Metairie Ochsner Health, New Orleans Eye Assoc. of NE LA dba Haik Humble Eye Ctr, West Monroe Eye Associates of Northeast Louisiana dba Haik Humble Eye Center, West Monroe |
| Maryland | The Retina Care Center, Baltimore The Retina Group of Washington, Chevy Chase Cumberland Valley Retina Consultants-Ophthalmology, Hagerstown Mid Atlantic Retina Specialist, Hagerstown |
| Massachusetts | Massachusetts Eye And Ear Infirmary, Boston Opthalmic Consultants of Boston, Boston New England Retina Consultants, PC, Springfield Massachusetts Eye Research and Surgery Institution (MERSI), Waltham Vitreo-Retinal Associates PC, Worcester |
| Michigan | Retina Associates of Michigan, Grand Blanc |
| Mississippi | Mississippi Retina Associates, Madison Deep Blue Retina Clinical Research PLLC, Southaven |
| Missouri | Retina Research Institute, LLC, St Louis |
| New Jersey | Mid Atlantic Retina - Cherry Hill, Cherry Hill New Jersey Retina, Teaneck New Jersey Retina, Toms River |
| New Mexico | Vision Research Center at Eye Associates of New Mexico, Albuquerque |
| New York | Sight MD, Brentwood Retina Vitreous Surgeons of Central New York, PC, Liverpool New York Ear & Eye- East 85th, New York Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology, New York Retina Associates of New York, Upper East Side, New York Seeta Eye center, Poughkeepsie |
| North Carolina | NC Retina Associates, Cary Graystone Eye, Hickory North Carolina Retina Associates, Wake Forest Piedmont Retina Specialist, Winston-Salem |
| Ohio | Cincinnati Eye Institute, Cincinnati University Hospitals Cleveland Medical Center, Cleveland The Ohio State University, Columbus Midwest Retina, Inc, Dublin |
| Oklahoma | Retina Vitreous Center - Edmond, Edmond Tulsa Retina Consultants, Tulsa |
| Oregon | Verum Research LLC, Eugene EyeHealth Northwest, Portland OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology, Portland Retina Northwest, The Highlands Building, Portland Cascade Medical Research Institute LLC, Springfield |
| Pennsylvania | Mid Atlantic Retina, Bethlehem Erie Retinal Surgery & Erie Retina Research, Erie Mid Atlantic Retina, Wills Eye Hospital, Philadelphia Vision Research Solutions - the Eye Institute, Philadelphia Sewickley Eye Group, Sewickley |
| South Carolina | Retina Consultants of Carolina, Greenville Charleston Neuroscience Institute LLC, Ladson Charleston Neuroscience Institute, LLC, Mt. Pleasant Palmetto Retina Center, West Columbia |
| South Dakota | Black Hills Regional Eye Institute, Rapid City |
| Tennessee | Tennessee Retina, PC, Nashville Vanderbilt Eye Institute, Nashville |
| Texas | Retina Research Institute of Texas, Abilene Austin Research Center for Retina, Austin Austin Retina Associates, Austin Retina Consultants Texas, Bellaire Star Retina PLLC, Burleson Retina Foundation of the Southwest, Dallas Texas Retina Associates, Dallas University of Texas Southwestern Medical Center, Dallas Retina Consultants of Texas, Katy Valley Retina Institute, P.A., McAllen Austin Retina Associates, Round Rock Medical Center Ophthalmology Associates, San Antonio Retina Associates of South Texas, San Antonio Retina Consultants of Texas, San Antonio Retina Consultants of Texas Brown Retina Institute, San Antonio Retina Center of Texas, Southlake Retina Consultants Texas, The Woodlands Tyler Retina Research Institute- Ophthalmology, Tyler |
| Utah | Retina Associates Of Utah Retina Specialist, Salt Lake City Rocky Mountain Retina Consultants, Salt Lake City Salt Lake Retina- Ophthalmology, West Jordan |
| Vermont | University of Vermont, Burlington |
| Virginia | Southeastern Retina Associates, Bristol Retina Group of Washington, Fairfax Piedmont Eye Center, Lynchburg Virginia Eye Institute, Richmond |
| Washington | Spokane Eye Clinical Research, Spokane |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.