An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD
- Conditions
- Geographic Atrophy Secondary to Age-related Macular Degeneration
- Interventions
- Registration Number
- NCT04770545
- Lead Sponsor
- Apellis Pharmaceuticals, Inc.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1200
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.
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 yearsover 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months PEGCETACOPLAN (APL-2) Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered monthly intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or monthly sham will receive IVT pegcetacoplan (15 mg/100 μL) monthly for up to approximately 36 months. Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 months PEGCETACOPLAN (APL-2) Participants from Study APL2-103 (NCT03777332) or those who completed the treatment at Month 24 from either Study APL2-303 (Derby, NCT03525613) or Study APL2-304 (Oaks, NCT03525600) and were administered every other month (EOM) intravitreal (IVT) pegcetacoplan (15 mg/100 μL) or EOM sham will receive IVT pegcetacoplan (15 mg/100 μL) EOM for up to approximately 36 months.
- Primary Outcome Measures
Name Time Method Incidence and severity of ocular and systemic adverse events Up to 36 Months
- Secondary Outcome Measures
Name Time Method Change from baseline in LL-BCVA score (study eye) Up to 36 Months LL-BCVA score as assessed by ETDRS chart at Month 12, Month 24, and Month 36
Change from baseline in the total area of GA lesion(s) in the study eye (in mm2) Up to 36 Months The total area of GA lesion(s) in the study eye (in mm2) as assessed by FAF at Month 12, Month 24, and Month 36
Change from baseline in NL-BCVA score (study eye) Up to 36 Months NL-BCVA score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Month 12, Month 24, and Month 36
Trial Locations
- Locations (167)
Northwestern Feinberg School of Medicine
🇺🇸Chicago, Illinois, United States
The Ohio State University
🇺🇸Columbus, Ohio, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Retinal Diagnostic Center
🇺🇸Campbell, California, United States
California Retina Consultants
🇺🇸Santa Barbara, California, United States
Retina Consultants of Orange County
🇺🇸Fullerton, California, United States
National Opthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Elman Retina Group
🇺🇸Baltimore, Maryland, United States
New England Retina Consultants, PC
🇺🇸Springfield, Massachusetts, United States
Associated Retinal Consultants, PC
🇺🇸Traverse City, Michigan, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
Vision Research Center Eye Associates of NM
🇺🇸Albuquerque, New Mexico, United States
Graystone Eye
🇺🇸Hickory, North Carolina, United States
Retina Vitreous Center, PLLC
🇺🇸Edmond, Oklahoma, United States
Oregon Retina LLP
🇺🇸Eugene, Oregon, United States
Brown Retina Institute
🇺🇸Bellaire, Texas, United States
IPEPO Instituto Da Visao
🇧🇷São Paulo, Brazil
Centre ophtalmologique Saint-Exupery
🇫🇷Saint-Cyr-sur-Loire, Lyon, France
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Oxford Eye Hospital
🇬🇧Oxford, United Kingdom
Retina Consultants of Houston, PA
🇺🇸Houston, Texas, United States
Retina Associates of South Texas
🇺🇸San Antonio, Texas, United States
Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Georgia Retina, PC
🇺🇸Marietta, Georgia, United States
Charlotte Eye Ear Nose and Throat Associates, PS
🇺🇸Charlotte, North Carolina, United States
Western Carolina Retinal Associates
🇺🇸Asheville, North Carolina, United States
Cleveland Clinic Cole Eye Institute
🇺🇸Cleveland, Ohio, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Valley Retina Institute
🇺🇸McAllen, Texas, United States
Duke University, Duke Eye Center
🇺🇸Durham, North Carolina, United States
Tennessee Retina, PC
🇺🇸Nashville, Tennessee, United States
University of Utah - John A. Moran Center
🇺🇸Salt Lake City, Utah, United States
Vitreoretinal Surgery
🇺🇸Minneapolis, Minnesota, United States
Retinal Research Institue, LLC
🇺🇸Phoenix, Arizona, United States
Associated Retina Consultants, Ltd.
🇺🇸Phoenix, Arizona, United States
Retina Northwest, PC
🇺🇸Portland, Oregon, United States
Eye Health Northwest
🇺🇸Portland, Oregon, United States
Retina Associates of Florida
🇺🇸Tampa, Florida, United States
University of South Florida
🇺🇸Tampa, Florida, United States
The Retina Partners
🇺🇸Encino, California, United States
Doheny Eye Center UCLA
🇺🇸Los Angeles, California, United States
Jacobs Retina Center, UCSD
🇺🇸La Jolla, California, United States
Atlantis Eyecare
🇺🇸Huntington Beach, California, United States
Orange County Retina Medical Group
🇺🇸Santa Ana, California, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
Northern California Retina Vitreous Associates
🇺🇸Mountain View, California, United States
Retina Institute of California Medical Group
🇺🇸Palm Desert, California, United States
Bay Area Retina Associates
🇺🇸Walnut Creek, California, United States
Southwest Retina Research Center, LLC
🇺🇸Durango, Colorado, United States
Byers Eye Institute, Stanford University
🇺🇸Palo Alto, California, United States
Florida Eye Microsurgical Institute, Inc.
🇺🇸Boynton Beach, Florida, United States
Danbury Eye Physicians & Surgeons, PC
🇺🇸Danbury, Connecticut, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Palm Beach Gardens
🇺🇸Palm Beach Gardens, Florida, United States
Eye Associates of Pinellas
🇺🇸Pinellas Park, Florida, United States
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Southeast Retina Center, PC
🇺🇸Augusta, Georgia, United States
Gailey Eye Clinic Retina Center
🇺🇸Bloomington, Illinois, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
The Retina Care Center
🇺🇸Baltimore, Maryland, United States
The Retina Group of Washington
🇺🇸Fairfax, Virginia, United States
Cumberland Valley Retina Center
🇺🇸Hagerstown, Maryland, United States
Mid Atlantic Retina Specialist
🇺🇸Hagerstown, Maryland, United States
NJ Retina
🇺🇸Toms River, New Jersey, 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
Retina Associates of Cleveland, Inc.
🇺🇸Youngstown, Ohio, United States
Retina Associates of Cleveland
🇺🇸Cleveland, Ohio, United States
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
Retina Vitreous Consultants
🇺🇸Monroeville, 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
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Retina Research Center PLLC
🇺🇸Austin, Texas, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Retina Consultants of Houston
🇺🇸The Woodlands, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Vitreoretinal Associates of Washington
🇺🇸Bellevue, Washington, United States
Emerson Clinical Research Institute
🇺🇸Falls Church, Virginia, United States
Centro Oftalmologico Dr. Charles S.A.
🇦🇷Buenos Aires, Argentina
Spokane Eye Clinical Research
🇺🇸Spokane, Washington, United States
OFTAR
🇦🇷Mendoza, Argentina
Fundacion Zambrano
🇦🇷Buenos Aires, Argentina
Microcirujia Ocular Rosario
🇦🇷Rosario, Argentina
Marsden Eye Specialist
🇦🇺Parramatta, New South Wales, Australia
Oftalmologos Especialistas
🇦🇷Santa Fe, Argentina
The Ashley Centre
🇦🇺Westmead, New South Wales, Australia
Lions Eye Institute
🇦🇺Nedlands, Australia
Centre for Eye Research Australia
🇦🇺East Melbourne, Victoria, Australia
Sydney Retina
🇦🇺Sydney, New South Wales, Australia
Strathfield Retina Clinic
🇦🇺Strathfield, New South Wales, Australia
Retina and Eye Consultantss
🇦🇺Hurstville, Australia
Save Sight Institute
🇦🇺Westmead, Australia
Ivey Eye Institute
🇨🇦London, Ontario, Canada
University of Ottawa Eye Institute
🇨🇦Ottawa, Ontario, Canada
Fakultni Nemocnice Ostrava
🇨🇿Ostrava-Poruba, Czechia
Retina Centre of Ottawa
🇨🇦Ottawa, Ontario, Canada
University hospital Kralovske Vinohrady
🇨🇿Prague, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha, Czechia
Gemini Eye Clinic
🇨🇿Zlín, Czechia
Centre Hospitalier Intercommunal de Creteil
🇫🇷Créteil cedex, France
CHU de Bordeaux
🇫🇷Bordeaux, France
CHU Dijon
🇫🇷Dijon, France
CHU de Nantes - Hotel Dieu
🇫🇷Nantes Cedex, France
Hopital Lariboisiere
🇫🇷Paris, France
CHNO des Quinze-Vingts
🇫🇷Paris, France
Maison Rouge Ophthalmologic Center
🇫🇷Strasbourg, France
CHU de Strasbourg Hopital Civil
🇫🇷Strasbourg, France
Clinique du Val d'Ouest
🇫🇷Écully, France
University Opthalmology Clinic
🇩🇪Freiburg im Breisgau, Germany
Universitats-Augenklinik Bonn
🇩🇪Bonn, Germany
Uniklinik Koln
🇩🇪Cologne, Germany
Uni-medizin Gottingen Augenklinik 3.B1.261
🇩🇪Göttingen, Germany
Klinikum der Stadt Ludwigshafen gGmbH
🇩🇪Ludwigshafen, Germany
Universitatsklinikum Schleswig-Holstein
🇩🇪Lübeck, Germany
Klinikum rechts der Isar
🇩🇪München, Germany
Augenklinik der LMU Munchen
🇩🇪München, Germany
Augenzentrum am St. Franziskus-Hospital
🇩🇪Münster, Germany
Universitatsklinikum Regensburg
🇩🇪Münster, Germany
Universitatsklinikum Munster
🇩🇪Münster, Germany
Assaf ha Rofeh MC
🇮🇱Be'er Ya'akov, Israel
STZ Eyetrial
🇩🇪Tübingen, Germany
Rambam Health Care Campus
🇮🇱Haifa, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Israel
ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
🇮🇹Milano, Italy
IRCCS San Raffaele
🇮🇹Milano, Italy
Academisch Medisch Centrum
🇳🇱Amsterdam, Netherlands
Southern Eye Specialists
🇳🇿Christchurch, New Zealand
Eye Surgery Center Professor Zagorski
🇵🇱Bydgoszcz, Poland
UNO-MED Centrum Medyne
🇵🇱Tarnów, Poland
Huddersfield Royal Infirmary
🇬🇧Huddersfield, West Yorkshire, United Kingdom
Instituto Oftalmologico Gomez-Ulla
🇪🇸Santiago De Compostela, Spain
Grupo Laser Vision
🇵🇱Rzeszów, Poland
Oftalmika Eye Hospital
🇵🇱Bydgoszcz, Poland
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
St James's University Hospital
🇬🇧Leeds, West Yorkshire, United Kingdom
Bristol Eye Hospital
🇬🇧Bristol, United Kingdom
Kings College Hospital NHS Trust
🇬🇧London, United Kingdom
Sunderland Eye Infirmary
🇬🇧Sunderland, United Kingdom
London Vision Clinic
🇬🇧London, United Kingdom
AXON Clinical, s.r.o.
🇨🇿Prague, Czechia
Retina Center of NJ, LLC
🇺🇸Bloomfield, New Jersey, United States
Michigan Medicine Kellogg Eye Center
🇺🇸Ann Arbor, Michigan, United States
Pinnacle Research Insitute
🇺🇸Fort Lauderdale, Florida, United States
Retina Group of New England - New London
🇺🇸Waterford, Connecticut, United States
East Florida Eye Institute
🇺🇸Stuart, Florida, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Centre monticelli Paradis
🇫🇷Marseille, France
Retina-Vitreous Associates Medical Group
🇺🇸Madison, Wisconsin, United States
Retina Specialty Institute
🇺🇸Pensacola, Florida, United States
Retina Associates of Utah, PC
🇺🇸Murray, Utah, United States
Hopital de la Croix-Rousse
🇫🇷Lyon, France
Oculomedica Eye Centre
🇵🇱Tarnów, Poland
Centre Ophtalmol de l Odeon
🇫🇷Paris, France
Blue Ocean Clinical Research
🇺🇸Clearwater, Florida, United States
Radboud university medical center Oogheelkunde
🇳🇱Nijmegen, Netherlands
Diagnostico Ocular
🇦🇷Buenos Aires, Argentina
Retina Health Center
🇺🇸Madison, Wisconsin, United States
Organizacion Medica de Investigacion (OMI)
🇦🇷Buenos Aires, Argentina
Instituto Oftalmologico de Cordoba
🇦🇷Córdoba, Argentina
Hamilton Eye Clinic
🇳🇿Hamilton, New Zealand
Centre Ophtalmo. Image/Laser
🇫🇷Paris, France
Bascom Palmer Eye Institute at Naples
🇺🇸Naples, Florida, United States
Royal Liverpool University Hospital
🇬🇧Liverpool, United Kingdom