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NCT04770545

PHASE3

An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD

Sponsor: Apellis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This is a phase 3, open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan (APL-2) in subjects with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) who participated in Study APL2-103 (NCT03777332) or completed the treatment at Month 24 of either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600).

Official title: A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

792

Start Date

2021-03-04

Completion Date

2025-09-05

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Geographic Atrophy Secondary to Age-related Macular Degeneration

Interventions

DRUG

PEGCETACOPLAN (APL-2)

Complement (C3) Inhibitor

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: Ocular-specific inclusion criteria apply to the study eye only. * Subjects must have participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600). * For subjects who participated in either the 303 or 304 studies, the condition listed below must also be met for participating in this study. * Subjects who did not fully stop study drug treatment, but missed the visit at Month 24, can also participate in the study. However, to participate, subjects must be seen within 60 days from the last day of the period allowed for the 24 months visit in the previous study. * The eyes of subjects must have transparency to permit visualization of parts inside the eye such as the retina and subjects must be able to look steadily at a provided target allowing the doctor to get good quality pictures from the eye. * Female subjects must be: * Women that cannot have children, or * Women who can have children must have a negative result of a blood pregnancy test on the first day of the study visit and agree to use ways to avoid pregnancy during the study and 90 days after the last dose of the study medication. * Males with female partners who can get pregnant must also agree to use ways to avoid pregnancy and agree not to donate sperm while in the study or until 90 days after administering the last dose of the study medication. * Agree to participate in the study by signing the consent document providing information about the study; and take part in all tests and assessments as required. Exclusion Criteria: Subjects cannot take part in the study if the eye that will be treated during the study currently meets any of the following conditions: * Participants in APL2 303/304 studies who fully stopped study drug treatment before the visit in month 24 but remain in the study to observe the study medication's safety. Those subjects who temporarily paused study drug treatment are still eligible to participate. * If, according to your doctor you currently have any disease affecting your eyes that could interfere with your vision, including diseases that affect your retina or macula (the center of the back of your eyes). And, if according to your doctor, the disease in your eyes is benign and does not interfere with the study (e.g. diseases that affects the periphery of the retina), you are also eligible to take part in the study. * If, according to your doctor you currently have any inflammation/infection in or around your eyes that could prohibit you from receiving an injection inside your eyes. * If, according to your doctor, any current disease that could directly interfere in your participation in the study or that could make it difficult for you to come to the scheduled visits during the next three years over the next 36 months. * If you have known allergies to fluorescein sodium, a solution that is injected into your body for eye testing; or to pegcetacoplan (the study drug) or any inactive substances in pegcetacoplan solution. * If you currently are pregnant, breastfeed or have a positive pregnancy test.

Locations (175)

Retinal Research Institute, LLC

Phoenix, Arizona, United States

Associated Retina Consultants, Ltd.

Phoenix, Arizona, United States

California Retina Consultants

Bakersfield, California, United States

Retinal Diagnostic Center

Campbell, California, United States

The Retina Partners

Encino, California, United States

Retina Consultants of Orange County

Fullerton, California, United States

Atlantis Eyecare

Huntington Beach, California, United States

Jacobs Retina Center, UCSD

La Jolla, California, United States

Doheny Eye Center UCLA

Los Angeles, California, United States

Northern California Retina Vitreous Associates

Mountain View, California, United States

Retina Institute of California Medical Group

Palm Desert, California, United States

Byers Eye Institute, Stanford University

Palo Alto, California, United States

Retina Consultants San Diego

Poway, California, United States

Orange County Retina Medical Group

Santa Ana, California, United States

California Retina Consultants

Santa Barbara, California, United States

Bay Area Retina Associates

Walnut Creek, California, United States

Southwest Retina Research Center, LLC

Durango, Colorado, United States

Danbury Eye Physicians & Surgeons, PC

Danbury, Connecticut, United States

Retina Group of New England - New London

Waterford, Connecticut, United States

Florida Eye Microsurgical Institute, Inc.

Boynton Beach, Florida, United States

Blue Ocean Clinical Research

Clearwater, Florida, United States

Pinnacle Research Institute

Fort Lauderdale, Florida, United States

Retina Health Center

Fort Myers, Florida, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Bascom Palmer Eye Institute

Miami, Florida, United States

Bascom Palmer Eye Institute at Naples

Naples, Florida, United States

Palm Beach Gardens

Palm Beach Gardens, Florida, United States

Retina Specialty Institute

Pensacola, Florida, United States

Eye Associates of Pinellas

Pinellas Park, Florida, United States

East Florida Eye Institute

Stuart, Florida, United States

Retina Associates of Florida

Tampa, Florida, United States

University of South Florida

Tampa, Florida, United States

Center for Retina and Macular Disease

Winter Haven, Florida, United States

Southeast Retina Center, PC

Augusta, Georgia, United States

Georgia Retina, PC

Marietta, Georgia, United States

Gailey Eye Clinic Retina Center

Bloomington, Illinois, United States

Northwestern Feinberg School of Medicine

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

Midwest Eye Institute

Indianapolis, Indiana, United States

Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky

Lexington, Kentucky, United States

The Retina Care Center

Baltimore, Maryland, United States

Elman Retina Group

Baltimore, Maryland, United States

The Retina Group of Washington

Chevy Chase, Maryland, United States

Cumberland Valley Retina Center

Hagerstown, Maryland, United States

Mid Atlantic Retina Specialist

Hagerstown, Maryland, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Tufts Medical Center

Boston, Massachusetts, United States

New England Retina Consultants, PC

Springfield, Massachusetts, United States

Michigan Medicine Kellogg Eye Center

Ann Arbor, Michigan, United States

Associated Retinal Consultants, PC

Grand Rapids, Michigan, United States

Associated Retinal Consultants, PC

Traverse City, Michigan, United States

Vitreoretinal Surgery

Minneapolis, Minnesota, United States

Sierra Eye Associates

Reno, Nevada, United States

Retina Center of NJ, LLC

Bloomfield, New Jersey, United States

NJ Retina

Teaneck, New Jersey, United States

NJ Retina

Toms River, New Jersey, United States

Vision Research Center Eye Associates of NM

Albuquerque, New Mexico, United States

Long Island Vitreoretinal Consultants

Great Neck, New York, United States

Vitreous Retina Macula Consultants of New York

New York, New York, United States

Ophthalmic Consultants of Long Island

Oceanside, New York, United States

Western Carolina Retinal Associates

Asheville, North Carolina, United States

Charlotte Eye Ear Nose and Throat Associates, PS

Charlotte, North Carolina, United States

Duke University, Duke Eye Center

Durham, North Carolina, United States

Graystone Eye

Hickory, North Carolina, United States

Retina Associates of Cleveland, Inc.

Cleveland, Ohio, United States

Retina Associates of Cleveland

Cleveland, Ohio, United States

Cleveland Clinic Cole Eye Institute

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Retina Associates of Cleveland, Inc.

Youngstown, Ohio, United States

Retina Vitreous Center, PLLC

Edmond, Oklahoma, United States

Oregon Retina LLP

Eugene, Oregon, United States

Retina Northwest, PC

Portland, Oregon, United States

Eye Health Northwest

Portland, Oregon, United States

Mid Atlantic Retina

Bethlehem, Pennsylvania, United States

Retina Vitreous Consultants

Monroeville, Pennsylvania, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

AIO Visionary Eye Care

West Mifflin, Pennsylvania, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Charles Retina Institute

Germantown, Tennessee, United States

Tennessee Retina, PC

Nashville, Tennessee, United States

Retina Research Center PLLC

Austin, Texas, United States

Brown Retina Institute

Bellaire, Texas, United States

Texas Retina Associates

Dallas, Texas, United States

Houston Eye Associates

Houston, Texas, United States

Retina Consultants of Houston, PA

Houston, Texas, United States

Valley Retina Institute

McAllen, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Retina Associates of South Texas

San Antonio, Texas, United States

Retina Consultants of Houston

The Woodlands, Texas, United States

Retina Associates of Utah, PC

Murray, Utah, United States

University of Utah - John A. Moran Center

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

The Retina Group of Washington

Fairfax, Virginia, United States

Emerson Clinical Research Institute

Falls Church, Virginia, United States

Vitreoretinal Associates of Washington

Bellevue, Washington, United States

Spokane Eye Clinical Research

Spokane, Washington, United States

Retina Health Center

Madison, Wisconsin, United States

Retina-Vitreous Associates Medical Group

Madison, Wisconsin, United States

Diagnostico Ocular

Buenos Aires, Argentina

And 75 more locations on ClinicalTrials.gov

Clinical Research Directory

An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (175)