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

Purpose

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)

Eligibility

Eligible Ages
Between 50 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pozelimab + Cemdisiran treatment group 		Randomized 1:1:1
  • Drug: Pozelimab
    Subcutaneous (SC) injection
    Other names:
    • REGN3918
  • Drug: Cemdisiran
    SC injection
    Other names:
    • ALN-CC5
Experimental
Cemdisiran monotherapy treatment group 		Randomized 1:1:1
  • Drug: Cemdisiran
    SC injection
    Other names:
    • ALN-CC5
Placebo Comparator
Placebo treatment group 		Randomized 1:1:1
  • Drug: Placebo
    SC injection

Recruiting Locations

Barnet Dulaney Perkins Eye Center-Ophthamalogy
Chandler, Arizona 85224

Barnet Dulaney Perkins Eye Center
Phoenix, Arizona 85016

Associated Retina Consultants
Phoenix, Arizona 85020

Retinal Research Institute
Phoenix, Arizona 85053

Retina Macula Institute of Arizona
Scottsdale, Arizona 85255

Retina Associates of Tuscan
Tucson, Arizona 85712

Retina Partners of Northwest Arkansas, PLLC
Springdale, Arkansas 72764

Retina Vitreous Associates Medical Group
Beverly Hills, California 90211

Retina Specialists of Beverly Hills- Department of Ophthalmology
Beverly Hills, California 90212

Eye Medical Center of Fresno
Fresno, California 93720

Salehi Retina Institute dba Retina Associates of Southern California
Huntington Beach, California 92647

University of California Irvine
Irvine, California 92617

University of California San Diego, Jacobs Retina Center
La Jolla, California 92093

South Coast Retina Center
Long Beach, California 90807

Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027

Jules Stein Eye Institute in David Geffen School of Medicine at Ucla
Los Angeles, California 90095

Retinal Consultants Medical Group Inc Modesto
Modesto, California 95356

Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California 94040

California Retina Consultants
Oxnard, California 93036

California Eye Specialists Medical Group Inc.
Pasadena, California 91107

Retina Consultants San Diego
Poway, California 92064

California Eye Specialists Medical Group, Inc.
Redlands, California 92373

Optic Eye Care
Rowland Heights, California 91748

UC Davis Health Eye Center
Sacramento, California 95817

Vrmg Inc
Sacramento, California 95825

Retinal Consultants Medical Group (RCMG) - Greenback Lane Retina Center
Sacramento, California 95841

West Coast Retina Medical Group, Inc.
San Francisco, California 94109

Orange County Retina Medical Group
Santa Ana, California 92705

Macula Retina Vitreous Research Institute
Torrance, California 90503

University of Colorado
Aurora, Colorado 80045

Retina Consultants of Southern Colorado
Colorado Springs, Colorado 80909

Retina Specialists of Colorado - Denver
Denver, Colorado 80222

Southwest Retina Research Center
Durango, Colorado 81303

Colorado Retina - Lakewood
Lakewood, Colorado 80228

Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
Longmont, Colorado 80503

Advanced Retina Institute-Ophthalmology
Bonita Springs, Florida 34134

Advanced Research
Coral Springs, Florida 33067

Retina Group of Florida
Fort Lauderdale, Florida 33308

ClearVista Clinical Research, Retina Center Tampa Bay
Hudson, Florida 34667

Florida Retina Institute, Jacksonville Perimeter Park- Ophthalmology
Jacksonville, Florida 32216

Florida Retina Consultants
Lakeland, Florida 33805

Bascom Palmer Eye Institute
Naples, Florida 34103

Florida Retina Institute - Orlando
Orlando, Florida 32806

Retina Care Specialists
Palm Beach Gardens, Florida 33410

Eye Associates of Pinellas
Pinellas Park, Florida 33782

Retina Group of Florida, RAS-Sarasota Retina Center-Ophthalmology
Sarasota, Florida 34232

Retina Vitreous Associates of Florida Saint Petersburg
St. Petersburg, Florida 33711

University of South Florida Ophthalmology
Tampa, Florida 33612

Center for Retina and Macular Disease
Winter Haven, Florida 33880

Southeast Retina Center
Augusta, Georgia 30909

Georgia Retina - Marietta
Marietta, Georgia 30060

University of Illinois at Chicago
Chicago, Illinois 60612

Retinal Vitreal Consultants
Chicago, Illinois 60616

The University of Chicago
Chicago, Illinois 60637

University Retina and Macula Associates PC - Lemont
Lemont, Illinois 60439

Illinois Retina Associates
Oak Park, Illinois 60304

Springfield Clinic Main Campus East
Springfield, Illinois 62703

Retina Associates, LLC
Lenexa, Kansas 66215

University of Louisville
Louisville, Kentucky 40202

Retina Associate New Orleans
Metairie, Louisiana 70001

Ross Davis Retina
Metairie, Louisiana 70006

Ochsner Health
New Orleans, Louisiana 70121

Eye Assoc. of NE LA dba Haik Humble Eye Ctr
West Monroe, Louisiana 71291

Eye Associates of Northeast Louisiana dba Haik Humble Eye Center
West Monroe, Louisiana 71291

The Retina Care Center
Baltimore, Maryland 21209

The Retina Group of Washington
Chevy Chase, Maryland 20815

Cumberland Valley Retina Consultants-Ophthalmology
Hagerstown, Maryland 21740

Mid Atlantic Retina Specialist
Hagerstown, Maryland 21740

Massachusetts Eye And Ear Infirmary
Boston, Massachusetts 02114

Opthalmic Consultants of Boston
Boston, Massachusetts 02114

New England Retina Consultants, PC
Springfield, Massachusetts 01107

Vitreo-Retinal Associates PC
Worcester, Massachusetts 01605

Retina Associates of Michigan
Grand Blanc, Michigan 48439

Mississippi Retina Associates
Madison, Mississippi 39110

Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi 38671

Retina Research Institute, LLC
St Louis, Missouri 63144

Mid Atlantic Retina - Cherry Hill
Cherry Hill, New Jersey 08034

New Jersey Retina
Teaneck, New Jersey 07666

New Jersey Retina
Toms River, New Jersey 08755

Vision Research Center at Eye Associates of New Mexico
Albuquerque, New Mexico 87109

Sight MD
Brentwood, New York 11717

Retina Vitreous Surgeons of Central New York, PC
Liverpool, New York 13088

New York Ear & Eye- East 85th
New York, New York 10028

Northwell Health- Manhattan, Ear, Eye and Throat Hospital- Ophthalmology
New York, New York 10065

Retina Associates of New York, Upper East Side
New York, New York 10075

Seeta Eye center
Poughkeepsie, New York 12603

NC Retina Associates
Cary, North Carolina 27511

Graystone Eye
Hickory, North Carolina 28602

North Carolina Retina Associates
Wake Forest, North Carolina 27587

Piedmont Retina Specialist
Winston-Salem, North Carolina 27103

Cincinnati Eye Institute
Cincinnati, Ohio 45242

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

The Ohio State University
Columbus, Ohio 43212

Midwest Retina, Inc
Dublin, Ohio 43016

Retina Vitreous Center - Edmond
Edmond, Oklahoma 73013

Tulsa Retina Consultants
Tulsa, Oklahoma 74114

Verum Research LLC
Eugene, Oregon 97401

Retina Northwest, The Highlands Building
Portland, Oregon 97221

EyeHealth Northwest
Portland, Oregon 97225

OHSU-Casey Eye Institute, Marquam Hill-Ophthalmology
Portland, Oregon 97239

Cascade Medical Research Institute LLC
Springfield, Oregon 97477

Mid Atlantic Retina
Bethlehem, Pennsylvania 18017

Erie Retinal Surgery & Erie Retina Research
Erie, Pennsylvania 16507

Mid Atlantic Retina, Wills Eye Hospital
Philadelphia, Pennsylvania 19107

Vision Research Solutions - the Eye Institute
Philadelphia, Pennsylvania 19141

Sewickley Eye Group
Sewickley, Pennsylvania 15143

Retina Consultants of Carolina
Greenville, South Carolina 29605

Charleston Neuroscience Institute LLC
Ladson, South Carolina 29456

Charleston Neuroscience Institute, LLC
Mt. Pleasant, South Carolina 29464

Palmetto Retina Center
West Columbia, South Carolina 29169

Black Hills Regional Eye Institute
Rapid City, South Dakota 57701

Tennessee Retina, PC
Nashville, Tennessee 37203

Vanderbilt Eye Institute
Nashville, Tennessee 37232

Retina Research Institute of Texas
Abilene, Texas 79606

Austin Research Center for Retina
Austin, Texas 78705

Austin Retina Associates
Austin, Texas 78705

Retina Consultants Texas
Bellaire, Texas 77401

Star Retina PLLC
Burleson, Texas 76028

Retina Foundation of the Southwest
Dallas, Texas 75231

Texas Retina Associates
Dallas, Texas 75231

University of Texas Southwestern Medical Center
Dallas, Texas 75390

Retina Consultants of Texas
Katy, Texas 77494

Valley Retina Institute, P.A.
McAllen, Texas 78503

Austin Retina Associates
Round Rock, Texas 78681

Medical Center Ophthalmology Associates
San Antonio, Texas 78240

Retina Associates of South Texas
San Antonio, Texas 78240

Retina Consultants of Texas
San Antonio, Texas 78240

Retina Consultants of Texas Brown Retina Institute
San Antonio, Texas 78251

Retina Center of Texas
Southlake, Texas 76092

Retina Consultants Texas
The Woodlands, Texas 77384

Tyler Retina Research Institute- Ophthalmology
Tyler, Texas 75703

Retina Associates Of Utah Retina Specialist
Salt Lake City, Utah 84107

Rocky Mountain Retina Consultants
Salt Lake City, Utah 84107

Salt Lake Retina- Ophthalmology
West Jordan, Utah 84088

University of Vermont
Burlington, Vermont 05401

Southeastern Retina Associates
Bristol, Virginia 24201

Retina Group of Washington
Fairfax, Virginia 22031

Piedmont Eye Center
Lynchburg, Virginia 24502

Virginia Eye Institute
Richmond, Virginia 23226

Spokane Eye Clinical Research
Spokane, Washington 99204

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com