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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration
• Intervention / Treatment: Drug: PEGCETACOPLAN (APL-2)

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1425
    • Diagnostico Ocular
  • Buenos Aires, Argentina, C1015 ABO
    • Organizacion Medica de Investigacion (OMI)
  • Buenos Aires, Argentina, C1023 AAQ
    • Fundacion Zambrano
  • Buenos Aires, Argentina, C1116ABA
    • Centro Oftalmológico Dr. Charles S.A.
  • Córdoba, Argentina, 5000
    • Instituto Oftalmológico de Córdoba
  • Mendoza, Argentina, 5500
    • Oftar
  • Rosario, Argentina, 2000
    • Microcirujia Ocular Rosario
  • Santa Fe, Argentina, S2000
    • Oftalmólogos Especialistas
• Australia
  • Hurstville, Australia, 2220
    • Retina and Eye Consultantss
  • Nedlands, Australia, 6009
    • Lions Eye Institute
  • Westmead, Australia, 2145
    • Save Sight Institute
  • New South Wales
    • Parramatta, New South Wales, Australia, 2150
      • Marsden Eye Specialist
    • Strathfield, New South Wales, Australia, 2135
      • Strathfield Retina Clinic
    • Sydney, New South Wales, Australia, 2000
      • Sydney Retina
    • Westmead, New South Wales, Australia, 2145
      • The Ashley Centre
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Centre For Eye Research Australia
• Brazil
  • São Paulo, Brazil, 04038-032
    • IPEPO Instituto Da Visao
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Ivey Eye Institute
    • Ottawa, Ontario, Canada, K1H 8L6
      • University of Ottawa Eye Institute
    • Ottawa, Ontario, Canada, K2B 7E9
      • Retina Centre of Ottawa
• Czechia
  • Ostrava-Poruba, Czechia, 708 52
    • Fakultní nemocnice Ostrava
  • Prague, Czechia, 10034
    • University Hospital Kralovske Vinohrady
  • Prague, Czechia, 150 00
    • Axon Clinical, s.r.o.
  • Praha, Czechia, 2128 08
    • Vseobecna fakultni nemocnice v Praze
  • Zlín, Czechia, 760 01
    • Gemini Eye Clinic
• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux
  • Créteil cedex, France, 94010
    • Centre Hospitalier Intercommunal de Créteil
  • Dijon, France, 21 079
    • CHU Dijon
  • Lyon, France, 69004
    • Hopital de la Croix-Rousse
  • Marseille, France, 13008
    • Centre monticelli Paradis
  • Nantes Cedex, France, 44093
    • CHU de Nantes - Hotel Dieu
  • Paris, France, 75010
    • Hopital Lariboisiere
  • Paris, France, 75012
    • CHNO des Quinze-Vingts
  • Paris, France, 75006
    • Centre Ophtalmol de l Odeon
  • Paris, France, 75015
    • Centre Ophtalmo. Image/Laser
  • Strasbourg, France, 67000
    • Maison Rouge Ophthalmologic Center
  • Strasbourg, France, 67091
    • CHU de Strasbourg Hopital Civil
  • Écully, France, 69130
    • Clinique du Val d'Ouest
  • Lyon
    • Saint-Cyr-sur-Loire, Lyon, France, 37540
      • Centre ophtalmologique Saint-Exupéry
• Germany
  • Bonn, Germany, 53127
    • Universitats-Augenklinik Bonn
  • Cologne, Germany, 50937
    • Uniklinik Koln
  • Freiburg im Breisgau, Germany, 79106
    • University Opthalmology Clinic
  • Göttingen, Germany, 37075
    • Uni-medizin Gottingen Augenklinik 3.B1.261
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen gGmbH
  • Lübeck, Germany, 23538
    • Universitatsklinikum Schleswig-Holstein
  • München, Germany, 81675
    • Klinikum rechts der Isar
  • München, Germany, 80336
    • Augenklinik der LMU München
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
  • Münster, Germany, 48145
    • Augenzentrum am St. Franziskus-Hospital
  • Münster, Germany, 48145
    • Universitätsklinikum Regensburg
  • Tübingen, Germany, 72076
    • STZ Eyetrial
• Israel
  • Be'er Ya'akov, Israel, 7030000
    • Assaf ha Rofeh MC
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus
  • Jerusalem, Israel, 91120
    • Hadassah Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Milano, Italy, 20132
    • IRCCS San Raffaele
  • Milano, Italy, 20157
    • ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academisch Medisch Centrum
  • Nijmegen, Netherlands, 6525 EX
    • Radboud university medical center Oogheelkunde
• New Zealand
  • Christchurch, New Zealand, 8013
    • Southern Eye Specialists
  • Hamilton, New Zealand, 3204
    • Hamilton Eye Clinic
• Poland
  • Bydgoszcz, Poland, 85-316
    • Eye Surgery Center Professor Zagorski
  • Bydgoszcz, Poland, 85-631
    • Oftalmika Eye Hospital
  • Rzeszów, Poland, 35-017
    • Grupo Laser Vision
  • Tarnów, Poland, 33-100
    • Oculomedica Eye Centre
  • Tarnów, Poland, 33-100
    • UNO-MED Centrum Medyne
• Spain
  • Madrid, Spain, 28222
    • Hospital Universitario Puerta de Hierro
  • Santiago De Compostela, Spain, 15706
    • Instituto Oftalmológico Gómez-Ulla
• United Kingdom
  • Bristol, United Kingdom, BS1 2LX
    • Bristol Eye Hospital
  • Liverpool, United Kingdom, L7 8XP
    • Royal Liverpool University Hospital
  • London, United Kingdom, W1G 7LA
    • London Vision Clinic
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital NHS Trust
  • Oxford, United Kingdom, OX3 9DU
    • Oxford Eye Hospital
  • Sunderland, United Kingdom, SR2 9HP
    • Sunderland Eye Infirmary
  • West Yorkshire
    • Huddersfield, West Yorkshire, United Kingdom, HD3 3EA
      • Huddersfield Royal Infirmary
    • Leeds, West Yorkshire, United Kingdom, LS9 7TF
      • St James's University Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Associated Retina Consultants, Ltd.
    • Phoenix, Arizona, United States, 85014
      • Retinal Research Institue, LLC
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
    • Campbell, California, United States, 95508
      • Retinal Diagnostic Center
    • Encino, California, United States, 91436
      • The Retina Partners
    • Fullerton, California, United States, 92835
      • Retina Consultants of Orange County
    • Huntington Beach, California, United States, 92647
      • Atlantis Eyecare
    • La Jolla, California, United States, 92093
      • Jacobs Retina Center, UCSD
    • Los Angeles, California, United States, 90033
      • Doheny Eye Center UCLA
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates
    • Palm Desert, California, United States, 92260
      • Retina Institute of California Medical Group
    • Palo Alto, California, United States, 94303
      • Byers Eye Institute, Stanford University
    • Poway, California, United States, 92064
      • Retina Consultants San Diego
    • Santa Ana, California, United States, 92705
      • Orange County Retina Medical Group
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants
    • Walnut Creek, California, United States, 94598
      • Bay Area Retina Associates
  • Colorado
    • Durango, Colorado, United States, 81301
      • Southwest Retina Research Center, LLC
  • Connecticut
    • Danbury, Connecticut, United States, 06810
      • Danbury Eye Physicians & Surgeons, PC
    • Waterford, Connecticut, United States, 06835
      • Retina Group of New England - New London
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Florida Eye Microsurgical Institute, Inc.
    • Clearwater, Florida, United States, 33761
      • Blue Ocean Clinical Research
    • Fort Lauderdale, Florida, United States, 33309
      • Pinnacle Research Insitute
    • Fort Myers, Florida, United States, 33907
      • Retina Health Center
    • Fort Myers, Florida, United States, 33912
      • National Opthalmic Research Institute
    • Miami, Florida, United States, 33136
      • Bascom Palmer Eye Institute
    • Naples, Florida, United States, 34103
      • Bascom Palmer Eye Institute at Naples
    • Palm Beach Gardens, Florida, United States, 33418
      • Palm Beach Gardens
    • Pensacola, Florida, United States, 32503
      • Retina Specialty Institute
    • Pinellas Park, Florida, United States, 33782
      • Eye Associates of Pinellas
    • Stuart, Florida, United States, 34994
      • East Florida Eye Institute
    • Tampa, Florida, United States, 33612
      • University of South Florida
    • Tampa, Florida, United States, 33609
      • Retina Associates of Florida
    • Winter Haven, Florida, United States, 33880
      • Center for Retina and Macular Disease
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center, PC
    • Marietta, Georgia, United States, 30060
      • Georgia Retina, PC
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Gailey Eye Clinic Retina Center
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60611
      • Northwestern Feinberg School of Medicine
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • MidWest Eye Institute
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • The Retina Care Center
    • Baltimore, Maryland, United States, 21236
      • Elman Retina Group
    • Chevy Chase, Maryland, United States, 92705
      • The Retina Group of Washington
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Center
    • Hagerstown, Maryland, United States, 21740
      • Mid Atlantic Retina Specialist
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Boston, Massachusetts, United States, 02116
      • Tufts Medical Center
    • Springfield, Massachusetts, United States, 01107
      • New England Retina Consultants, PC
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Michigan Medicine Kellogg Eye Center
    • Grand Rapids, Michigan, United States, 49546
      • Associated Retinal Consultants, PC
    • Traverse City, Michigan, United States, 49686
      • Associated Retinal Consultants, PC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55435
      • VitreoRetinal Surgery
  • Nevada
    • Reno, Nevada, United States, 89503
      • Sierra Eye Associates
  • New Hampshire
    • Manchester, New Hampshire, United States, 03244
      • Sara Gater
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • Retina Center of NJ, LLC
    • Teaneck, New Jersey, United States, 07666
      • NJ Retina
    • Toms River, New Jersey, United States, 08755
      • NJ Retina
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Vision Research Center Eye Associates of NM
  • New York
    • Great Neck, New York, United States, 11021
      • Long Island Vitreoretinal Consultants
    • New York, New York, United States, 10022
      • Vitreous Retina Macula Consultants of New York
    • Oceanside, New York, United States, 11572
      • Ophthalmic Consultants of Long Island
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Western Carolina Retinal Associates
    • Charlotte, North Carolina, United States, 28210
      • Charlotte Eye Ear Nose and Throat Associates, PS
    • Durham, North Carolina, United States, 27710
      • Duke University, Duke Eye Center
    • Hickory, North Carolina, United States, 28602
      • Graystone Eye
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Cole Eye Institute
    • Cleveland, Ohio, United States, 44122
      • Retina Associates of Cleveland, Inc.
    • Cleveland, Ohio, United States, 44130
      • Retina Associates of Cleveland
    • Columbus, Ohio, United States, 43212
      • The Ohio State University
    • Youngstown, Ohio, United States, 44505
      • Retina Associates of Cleveland, Inc.
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Retina Vitreous Center, PLLC
  • Oregon
    • Eugene, Oregon, United States, 97405
      • Oregon Retina LLP
    • Portland, Oregon, United States, 97221
      • Retina Northwest, PC
    • Portland, Oregon, United States, 97225
      • Eye Health Northwest
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18107
      • Mid Atlantic Retina
    • Monroeville, Pennsylvania, United States, 15146
      • Retina Vitreous Consultants
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina
    • Philadelphia, Pennsylvania, United States, 19006
      • Mid Atlantic Retina
    • West Mifflin, Pennsylvania, United States, 15122
      • AIO Visionary Eye Care
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Regional Eye Institute
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institute
    • Nashville, Tennessee, United States, 78503
      • Tennessee Retina, PC
  • Texas
    • Austin, Texas, United States, 78750
      • Retina Research Center PLLC
    • Bellaire, Texas, United States, 77401
      • Brown Retina Institute
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston, PA
    • Houston, Texas, United States, 77025
      • Houston Eye Associates
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute
    • San Antonio, Texas, United States, 78240
      • Medical Center Ophthalmology Associates
    • San Antonio, Texas, United States, 78240
      • Retina Associates of South Texas
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
  • Utah
    • Murray, Utah, United States, 84107
      • Retina Associates of Utah, PC
    • Salt Lake City, Utah, United States, 84312
      • University of Utah - John A. Moran Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
    • Fairfax, Virginia, United States, 22031
      • The Retina Group of Washington
    • Falls Church, Virginia, United States, 22046
      • Emerson Clinical Research Institute
  • Washington
    • Bellevue, Washington, United States, 98004
      • Vitreoretinal Associates of Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinical Research
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Retina Health Center
    • Madison, Wisconsin, United States, 53705
      • Retina-Vitreous Associates Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months; 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.	Drug: PEGCETACOPLAN (APL-2); Complement (C3) Inhibitor
Experimental: Pegcetacoplan, 15 mg/100 μL, every other month (EOM) for up to 36 months; 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.	Drug: PEGCETACOPLAN (APL-2); Complement (C3) Inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of ocular and systemic adverse events	Up to 36 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in the total area of GA lesion(s) in the study eye (in mm2)	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	Up to 36 Months
Change from baseline in NL-BCVA score (study eye)	NL-BCVA score as assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Month 12, Month 24, and Month 36	Up to 36 Months
Change from baseline in LL-BCVA score (study eye)	LL-BCVA score as assessed by ETDRS chart at Month 12, Month 24, and Month 36	Up to 36 Months

Collaborators and Investigators

• Sponsor: Apellis Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2021
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Eye Diseases; Retinal Degeneration; Retinal Diseases; Pathological Conditions, Anatomical; Neoplastic Processes; Macular Degeneration; Neoplasm Metastasis; Geographic Atrophy; Atrophy
• Other Study ID Numbers: APL2-GA-305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No