Recruiting

Phase 3

Pozelimab & CemdisiranA Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT06541704

Conditions

Age-related Macular Degeneration (AMD)

Geographic Atrophy (GA)

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Pozelimab

Cemdisiran

Placebo

Study Details

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)

Conditions

Age-related Macular Degeneration (AMD)

Geographic Atrophy (GA)

Study ID

NCT06541704

Start date

Oct 30, 2024

Status verified date

Aug, 2026

Completion date

Apr 9, 2033

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

975 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pozelimab + Cemdisiran treatment group

Randomized 1:1:1

experimental: Cemdisiran monotherapy treatment group

Randomized 1:1:1

placebo comparator: Placebo treatment group

Randomized 1:1:1

Interventions

Pozelimab

Subcutaneous (SC) injection

Cemdisiran

SC injection

Placebo

SC injection

Primary outcome measure

Growth rate (slope) of total GA lesion area (mm^2 /year) from baseline, measured by Fundus Autofluorescence (FAF) [ Time Frame: To week 52 ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643 clinicaltrials@regeneron.com

Locations

Barnet Dulaney Perkins Eye Center-Ophthamalogy

Recruiting

Chandler, Arizona, United States, 85224

Barnet Dulaney Perkins Eye Center

Recruiting

Phoenix, Arizona, United States, 85016

Associated Retina Consultants

Recruiting

Phoenix, Arizona, United States, 85020

Retinal Research Institute

Recruiting

Phoenix, Arizona, United States, 85053

Retina Macula Institute of Arizona

Recruiting

Scottsdale, Arizona, United States, 85255

Retina Associates of Tuscan

Recruiting

Tucson, Arizona, United States, 85712

Retina Partners of Northwest Arkansas, PLLC

Recruiting

Springdale, Arkansas, United States, 72764

Retina Vitreous Associates Medical Group

Recruiting

Beverly Hills, California, United States, 90211

Retina Specialists of Beverly Hills- Department of Ophthalmology

Recruiting

Beverly Hills, California, United States, 90212

Eye Medical Center of Fresno

Recruiting

Fresno, California, United States, 93720

Salehi Retina Institute dba Retina Associates of Southern California

Recruiting

Huntington Beach, California, United States, 92647

University of California Irvine

Recruiting

Irvine, California, United States, 92617

University of California San Diego, Jacobs Retina Center

Recruiting

La Jolla, California, United States, 92093

South Coast Retina Center

Recruiting

Long Beach, California, United States, 90807

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, United States, 90027

Jules Stein Eye Institute in David Geffen School of Medicine at UCLA

Recruiting

Los Angeles, California, United States, 90095

Retinal Consultants Medical Group Inc Modesto

Recruiting

Modesto, California, United States, 95356

Northern California Retina Vitreous Associates Medical Group, Inc.

Recruiting

Mountain View, California, United States, 94040

California Retina Consultants

Recruiting

Oxnard, California, United States, 93036

California Eye Specialists Medical Group Inc.

Recruiting

Pasadena, California, United States, 91107

Retina Consultants San Diego

Recruiting

Poway, California, United States, 92064

California Eye Specialists Medical Group, Inc.

Recruiting

Redlands, California, United States, 92373

Optic Eye Care

Recruiting

Rowland Heights, California, United States, 91748

UC Davis Health Eye Center

Recruiting

Sacramento, California, United States, 95817

Vrmg Inc

Recruiting

Sacramento, California, United States, 95825

Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center

Recruiting

Sacramento, California, United States, 95841

West Coast Retina Medical Group, Inc.

Recruiting

San Francisco, California, United States, 94109

Orange County Retina Medical Group

Recruiting

Santa Ana, California, United States, 92705

Macula Retina Vitreous Research Institute

Recruiting

Torrance, California, United States, 90503

University of Colorado

Recruiting

Aurora, Colorado, United States, 80045

Retina Consultants of Southern Colorado

Recruiting

Colorado Springs, Colorado, United States, 80909

Retina Specialists of Colorado - Denver

Recruiting

Denver, Colorado, United States, 80222

Southwest Retina Research Center

Recruiting

Durango, Colorado, United States, 81303

Colorado Retina - Lakewood

Recruiting

Lakewood, Colorado, United States, 80228

Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute

Recruiting

Longmont, Colorado, United States, 80503

Advanced Retina Institute-Ophthalmology

Recruiting

Bonita Springs, Florida, United States, 34134

Advanced Research

Recruiting

Coral Springs, Florida, United States, 33067

Retina Group of Florida

Recruiting

Fort Lauderdale, Florida, United States, 33308

ClearVista Clinical Research, Retina Center Tampa Bay

Recruiting

Hudson, Florida, United States, 34667

Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology

Recruiting

Jacksonville, Florida, United States, 32216

Florida Retina Consultants

Recruiting

Lakeland, Florida, United States, 33805

Bascom Palmer Eye Institute

Recruiting

Naples, Florida, United States, 34103

Florida Retina Institute - Orlando

Recruiting

Orlando, Florida, United States, 32806

Retina Care Specialists

Recruiting

Palm Beach Gardens, Florida, United States, 33410

Eye Associates of Pinellas

Recruiting

Pinellas Park, Florida, United States, 33782

Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology

Recruiting

Sarasota, Florida, United States, 34232

Retina Vitreous Associates of Florida Saint Petersburg

Recruiting

St. Petersburg, Florida, United States, 33711

University of South Florida Ophthalmology

Recruiting

Tampa, Florida, United States, 33612

Center for Retina and Macular Disease

Recruiting

Winter Haven, Florida, United States, 33880

Southeast Retina Center

Recruiting

Augusta, Georgia, United States, 30909

Georgia Retina - Marietta

Recruiting

Marietta, Georgia, United States, 30060

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Retinal Vitreal Consultants

Recruiting

Chicago, Illinois, United States, 60616

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

University Retina and Macula Associates PC - Lemont

Recruiting

Lemont, Illinois, United States, 60439

Illinois Retina Associates

Recruiting

Oak Park, Illinois, United States, 60304

Springfield Clinic Main Campus East

Recruiting

Springfield, Illinois, United States, 62703

Retina Associates, LLC

Recruiting

Lenexa, Kansas, United States, 66215

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Retina Associate New Orleans

Recruiting

Metairie, Louisiana, United States, 70001

Ross Davis Retina

Recruiting

Metairie, Louisiana, United States, 70001

Ochsner Health

Recruiting

New Orleans, Louisiana, United States, 70121

Eye Assoc. of NE LA dba Haik Humble Eye Ctr

Recruiting

West Monroe, Louisiana, United States, 71291

Eye Associates of Northeast Louisiana dba Haik Humble Eye Center

Recruiting

West Monroe, Louisiana, United States, 71291

The Retina Care Center

Recruiting

Baltimore, Maryland, United States, 21209

The Retina Group of Washington

Recruiting

Chevy Chase, Maryland, United States, 20815

Cumberland Valley Retina Consultants-Ophthalmology

Recruiting

Hagerstown, Maryland, United States, 21740

Mid Atlantic Retina Specialist

Recruiting

Hagerstown, Maryland, United States, 21740

Massachusetts Eye And Ear Infirmary

Recruiting

Boston, Massachusetts, United States, 02114

Opthalmic Consultants of Boston

Recruiting

Boston, Massachusetts, United States, 02114

New England Retina Consultants, PC

Recruiting

Springfield, Massachusetts, United States, 01107

Massachusetts Eye Research and Surgery Institution (MERSI)

Recruiting

Waltham, Massachusetts, United States, 02451

Vitreo-Retinal Associates PC

Recruiting

Worcester, Massachusetts, United States, 01605

Retina Associates of Michigan

Recruiting

Grand Blanc, Michigan, United States, 48439

Mississippi Retina Associates

Recruiting

Madison, Mississippi, United States, 39110

Deep Blue Retina Clinical Research PLLC

Recruiting

Southaven, Mississippi, United States, 38671

Retina Research Institute, LLC

Recruiting

St Louis, Missouri, United States, 63144

Mid Atlantic Retina - Cherry Hill

Recruiting

Cherry Hill, New Jersey, United States, 08034

New Jersey Retina

Recruiting

Teaneck, New Jersey, United States, 07666

New Jersey Retina

Recruiting

Toms River, New Jersey, United States, 08755

Vision Research Center at Eye Associates of New Mexico

Recruiting

Albuquerque, New Mexico, United States, 87109

Sight MD

Recruiting

Brentwood, New York, United States, 11717

Retina Vitreous Surgeons of Central New York, PC

Recruiting

Liverpool, New York, United States, 13088

New York Ear & Eye- East 85th

Recruiting

New York, New York, United States, 10028

Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology

Recruiting

New York, New York, United States, 10065

Retina Associates of New York, Upper East Side

Recruiting

New York, New York, United States, 10075

Seeta Eye center

Recruiting

Poughkeepsie, New York, United States, 12603

NC Retina Associates

Recruiting

Cary, North Carolina, United States, 27511

Graystone Eye

Recruiting

Hickory, North Carolina, United States, 28602

North Carolina Retina Associates

Recruiting

Wake Forest, North Carolina, United States, 27587

Piedmont Retina Specialist

Recruiting

Winston-Salem, North Carolina, United States, 27103

Cincinnati Eye Institute

Recruiting

Cincinnati, Ohio, United States, 45242

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43212

Midwest Retina, Inc

Recruiting

Dublin, Ohio, United States, 43016

Retina Vitreous Center - Edmond

Recruiting

Edmond, Oklahoma, United States, 73013

Tulsa Retina Consultants

Recruiting

Tulsa, Oklahoma, United States, 74114

Verum Research LLC

Recruiting

Eugene, Oregon, United States, 97401

Retina Northwest, The Highlands Building

Recruiting

Portland, Oregon, United States, 97221

EyeHealth Northwest

Recruiting

Portland, Oregon, United States, 97225

OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology

Recruiting

Portland, Oregon, United States, 97239

Cascade Medical Research Institute LLC

Recruiting

Springfield, Oregon, United States, 97477

Mid Atlantic Retina

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Erie Retinal Surgery & Erie Retina Research

Recruiting

Erie, Pennsylvania, United States, 16507

Mid Atlantic Retina, Wills Eye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Vision Research Solutions - the Eye Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19141

Sewickley Eye Group

Recruiting

Sewickley, Pennsylvania, United States, 15143

Retina Consultants of Carolina

Recruiting

Greenville, South Carolina, United States, 29605

Charleston Neuroscience Institute LLC

Recruiting

Ladson, South Carolina, United States, 29456

Charleston Neuroscience Institute, LLC

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Palmetto Retina Center

Recruiting

West Columbia, South Carolina, United States, 29169

Black Hills Regional Eye Institute

Recruiting

Rapid City, South Dakota, United States, 57701

Tennessee Retina, PC

Recruiting

Nashville, Tennessee, United States, 37203

Vanderbilt Eye Institute

Recruiting

Nashville, Tennessee, United States, 37232

Retina Research Institute of Texas

Recruiting

Abilene, Texas, United States, 79606

Austin Research Center for Retina

Recruiting

Austin, Texas, United States, 78705

Austin Retina Associates

Recruiting

Austin, Texas, United States, 78705

Retina Consultants Texas

Recruiting

Bellaire, Texas, United States, 77401

Star Retina PLLC

Recruiting

Burleson, Texas, United States, 76028

Retina Foundation of the Southwest

Recruiting

Dallas, Texas, United States, 75231

Texas Retina Associates

Recruiting

Dallas, Texas, United States, 75231

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Retina Consultants of Texas

Recruiting

Katy, Texas, United States, 77494

Valley Retina Institute, P.A.

Recruiting

McAllen, Texas, United States, 78503

Austin Retina Associates

Recruiting

Round Rock, Texas, United States, 78681

Medical Center Ophthalmology Associates

Recruiting

San Antonio, Texas, United States, 78240

Retina Associates of South Texas

Recruiting

San Antonio, Texas, United States, 78240

Retina Consultants of Texas

Recruiting

San Antonio, Texas, United States, 78240

Retina Consultants of Texas Brown Retina Institute

Recruiting

San Antonio, Texas, United States, 78251

Retina Center of Texas

Recruiting

Southlake, Texas, United States, 76092

Retina Consultants Texas

Recruiting

The Woodlands, Texas, United States, 77384

Tyler Retina Research Institute- Ophthalmology

Recruiting

Tyler, Texas, United States, 75703

Retina Associates Of Utah Retina Specialist

Recruiting

Salt Lake City, Utah, United States, 84107

Rocky Mountain Retina Consultants

Recruiting

Salt Lake City, Utah, United States, 84107

Salt Lake Retina- Ophthalmology

Recruiting

West Jordan, Utah, United States, 84088

University of Vermont

Recruiting

Burlington, Vermont, United States, 05401

Southeastern Retina Associates

Recruiting

Bristol, Virginia, United States, 24201

Retina Group of Washington

Recruiting

Fairfax, Virginia, United States, 22031

Piedmont Eye Center

Recruiting

Lynchburg, Virginia, United States, 24502

Virginia Eye Institute

Recruiting

Richmond, Virginia, United States, 23226

Spokane Eye Clinical Research

Recruiting

Spokane, Washington, United States, 99204

Retina Centre of Ottawa

Recruiting

Ottawa, Ontario, Canada, K2B 7E9

Centre Hospitalier Universitaire de Quebec Universite Laval

Recruiting

Québec, Canada, G1S 4L8

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

GA secondary to AMD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-08-25.