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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

Sponsor: Regeneron Pharmaceuticals · Participants: 975 · Started: Oct 30, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06541704

Locations in the U.S.

ArizonaBarnet 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
ArkansasRetina Partners of Northwest Arkansas, PLLC, Springdale
CaliforniaRetina 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
ColoradoUniversity 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
FloridaAdvanced 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
GeorgiaSoutheast Retina Center, Augusta
Georgia Retina - Marietta, Marietta
IllinoisRetinal 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
KansasRetina Associates, LLC, Lenexa
KentuckyUniversity of Louisville, Louisville
LouisianaRetina 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
MarylandThe Retina Care Center, Baltimore
The Retina Group of Washington, Chevy Chase
Cumberland Valley Retina Consultants-Ophthalmology, Hagerstown
Mid Atlantic Retina Specialist, Hagerstown
MassachusettsMassachusetts 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
MichiganRetina Associates of Michigan, Grand Blanc
MississippiMississippi Retina Associates, Madison
Deep Blue Retina Clinical Research PLLC, Southaven
MissouriRetina Research Institute, LLC, St Louis
New JerseyMid Atlantic Retina - Cherry Hill, Cherry Hill
New Jersey Retina, Teaneck
New Jersey Retina, Toms River
New MexicoVision Research Center at Eye Associates of New Mexico, Albuquerque
New YorkSight 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 CarolinaNC Retina Associates, Cary
Graystone Eye, Hickory
North Carolina Retina Associates, Wake Forest
Piedmont Retina Specialist, Winston-Salem
OhioCincinnati Eye Institute, Cincinnati
University Hospitals Cleveland Medical Center, Cleveland
The Ohio State University, Columbus
Midwest Retina, Inc, Dublin
OklahomaRetina Vitreous Center - Edmond, Edmond
Tulsa Retina Consultants, Tulsa
OregonVerum 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
PennsylvaniaMid 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 CarolinaRetina Consultants of Carolina, Greenville
Charleston Neuroscience Institute LLC, Ladson
Charleston Neuroscience Institute, LLC, Mt. Pleasant
Palmetto Retina Center, West Columbia
South DakotaBlack Hills Regional Eye Institute, Rapid City
TennesseeTennessee Retina, PC, Nashville
Vanderbilt Eye Institute, Nashville
TexasRetina 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
UtahRetina Associates Of Utah Retina Specialist, Salt Lake City
Rocky Mountain Retina Consultants, Salt Lake City
Salt Lake Retina- Ophthalmology, West Jordan
VermontUniversity of Vermont, Burlington
VirginiaSoutheastern Retina Associates, Bristol
Retina Group of Washington, Fairfax
Piedmont Eye Center, Lynchburg
Virginia Eye Institute, Richmond
WashingtonSpokane 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.