Clinical trial NCT04770545: An Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan (APL-2) in Subjects With Geographic Atrophy Secondary to AMD
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Geographic Atrophy Secondary to Age-related Macular Degeneration
Lead sponsor: Apellis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-25
Enrollment: 1200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence and severity of ocular and systemic adverse events
timeFrame: Up to 36 Months
Secondary outcomes:
measure: Change from baseline in the total area of GA lesion(s) in the study eye (in mm2)
timeFrame: Up to 36 Months
measure: Change from baseline in NL-BCVA score (study eye)
timeFrame: Up to 36 Months
measure: Change from baseline in LL-BCVA score (study eye)
timeFrame: Up to 36 Months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institue, LLC
state: Arizona
city: Phoenix
country: United States
facility: Associated Retina Consultants, Ltd.
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Campbell
country: United States
facility: Retinal Diagnostic Center
state: California
city: Encino
country: United States
facility: The Retina Partners
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Huntington Beach
country: United States
facility: Atlantis Eyecare
state: California
city: La Jolla
country: United States
facility: Jacobs Retina Center, UCSD
state: California
city: Los Angeles
country: United States
facility: Doheny Eye Center UCLA
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates
state: California
city: Palm Desert
country: United States
facility: Retina Institute of California Medical Group
state: California
city: Palo Alto
country: United States
facility: Byers Eye Institute, Stanford University
state: California
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Durango
country: United States
facility: Southwest Retina Research Center, LLC
state: Colorado
city: Danbury
country: United States
facility: Danbury Eye Physicians & Surgeons, PC
state: Connecticut
city: Waterford
country: United States
facility: Retina Group of New England - New London
state: Connecticut
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc.
state: Florida
city: Clearwater
country: United States
facility: Blue Ocean Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Pinnacle Research Insitute
state: Florida
city: Fort Myers
country: United States
facility: Retina Health Center
state: Florida
city: Fort Myers
country: United States
facility: National Opthalmic Research Institute
state: Florida
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Naples
country: United States
facility: Bascom Palmer Eye Institute at Naples
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Gardens
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Pinellas Park
country: United States
facility: Eye Associates of Pinellas
state: Florida
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
city: Tampa
country: United States
facility: Retina Associates of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Winter Haven
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center, PC
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina, PC
state: Georgia
city: Bloomington
country: United States
facility: Gailey Eye Clinic Retina Center
state: Illinois
city: Chicago
country: United States
facility: Northwestern Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Lexington
country: United States
facility: Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: The Retina Care Center
state: Maryland
city: Baltimore
country: United States
facility: Elman Retina Group
state: Maryland
city: Chevy Chase
country: United States
facility: The Retina Group of Washington
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Center
state: Maryland
city: Hagerstown
country: United States
facility: Mid Atlantic Retina Specialist
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: New England Retina Consultants, PC
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine Kellogg Eye Center
state: Michigan
city: Grand Rapids
country: United States
facility: Associated Retinal Consultants, PC
state: Michigan
city: Traverse City
country: United States
facility: Associated Retinal Consultants, PC
state: Michigan
city: Minneapolis
country: United States
facility: Vitreoretinal Surgery
state: Minnesota
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Retina Center of NJ, LLC
state: New Jersey
city: Teaneck
country: United States
facility: NJ Retina
state: New Jersey
city: Toms River
country: United States
facility: NJ Retina
state: New Jersey
city: Albuquerque
country: United States
facility: Vision Research Center Eye Associates of NM
state: New Mexico
city: Great Neck
country: United States
facility: Long Island Vitreoretinal Consultants
state: New York
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York
state: New York
city: Oceanside
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Asheville
country: United States
facility: Western Carolina Retinal Associates
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates, PS
state: North Carolina
city: Durham
country: United States
facility: Duke University, Duke Eye Center
state: North Carolina
city: Hickory
country: United States
facility: Graystone Eye
state: North Carolina
city: Cleveland
country: United States
facility: Retina Associates of Cleveland, Inc.
state: Ohio
city: Cleveland
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Cole Eye Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Youngstown
country: United States
facility: Retina Associates of Cleveland, Inc.
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center, PLLC
state: Oklahoma
city: Eugene
country: United States
facility: Oregon Retina LLP
state: Oregon
city: Portland
country: United States
facility: Retina Northwest, PC
state: Oregon
city: Portland
country: United States
facility: Eye Health Northwest
state: Oregon
city: Bethlehem
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Monroeville
country: United States
facility: Retina Vitreous Consultants
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: West Mifflin
country: United States
facility: AIO Visionary Eye Care
state: Pennsylvania
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Germantown
country: United States
facility: Charles Retina Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Austin
country: United States
facility: Retina Research Center PLLC
state: Texas
city: Bellaire
country: United States
facility: Brown Retina Institute
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston, PA
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: San Antonio
country: United States
facility: Retina Associates of South Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Murray
country: United States
facility: Retina Associates of Utah, PC
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah - John A. Moran Center
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: The Retina Group of Washington
state: Virginia
city: Falls Church
country: United States
facility: Emerson Clinical Research Institute
state: Virginia
city: Bellevue
country: United States
facility: Vitreoretinal Associates of Washington
state: Washington
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Madison
country: United States
facility: Retina Health Center
state: Wisconsin
city: Madison
country: United States
facility: Retina-Vitreous Associates Medical Group
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Diagnostico Ocular
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigacion (OMI)
city: Buenos Aires
country: Argentina
facility: Fundacion Zambrano
city: Buenos Aires
country: Argentina
facility: Centro Oftalmologico Dr. Charles S.A.
city: Córdoba
country: Argentina
facility: Instituto Oftalmologico de Cordoba
city: Mendoza
country: Argentina
facility: OFTAR
city: Rosario
country: Argentina
facility: Microcirujia Ocular Rosario
city: Santa Fe
country: Argentina
facility: Oftalmologos Especialistas
city: Parramatta
country: Australia
facility: Marsden Eye Specialist
state: New South Wales
city: Strathfield
country: Australia
facility: Strathfield Retina Clinic
state: New South Wales
city: Sydney
country: Australia
facility: Sydney Retina
state: New South Wales
city: Westmead
country: Australia
facility: The Ashley Centre
state: New South Wales
city: East Melbourne
country: Australia
facility: Centre for Eye Research Australia
state: Victoria
city: Hurstville
country: Australia
facility: Retina and Eye Consultantss
city: Nedlands
country: Australia
facility: Lions Eye Institute
city: Westmead
country: Australia
facility: Save Sight Institute
city: São Paulo
country: Brazil
facility: IPEPO Instituto Da Visao
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Eye Institute
state: Ontario
city: Ottawa
country: Canada
facility: Retina Centre of Ottawa
state: Ontario
city: Ostrava-Poruba
country: Czechia
facility: Fakultni Nemocnice Ostrava
city: Prague
country: Czechia
facility: University hospital Kralovske Vinohrady
city: Prague
country: Czechia
facility: AXON Clinical, s.r.o.
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze
city: Zlín
country: Czechia
facility: Gemini Eye Clinic
city: Saint-Cyr-sur-Loire
country: France
facility: Centre ophtalmologique Saint-Exupery
state: Lyon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Créteil cedex
country: France
facility: Centre Hospitalier Intercommunal de Creteil
city: Dijon
country: France
facility: CHU Dijon
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
city: Marseille
country: France
facility: Centre monticelli Paradis
city: Nantes Cedex
country: France
facility: CHU de Nantes - Hotel Dieu
city: Paris
country: France
facility: Centre Ophtalmol de l Odeon
city: Paris
country: France
facility: Hopital Lariboisiere
city: Paris
country: France
facility: CHNO des Quinze-Vingts
city: Paris
country: France
facility: Centre Ophtalmo. Image/Laser
city: Strasbourg
country: France
facility: Maison Rouge Ophthalmologic Center
city: Strasbourg
country: France
facility: CHU de Strasbourg Hopital Civil
city: Écully
country: France
facility: Clinique du Val d'Ouest
city: Bonn
country: Germany
facility: Universitats-Augenklinik Bonn
city: Cologne
country: Germany
facility: Uniklinik Koln
city: Freiburg im Breisgau
country: Germany
facility: University Opthalmology Clinic
city: Göttingen
country: Germany
facility: Uni-medizin Gottingen Augenklinik 3.B1.261
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen gGmbH
city: Lübeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: München
country: Germany
facility: Augenklinik der LMU Munchen
city: München
country: Germany
facility: Klinikum rechts der Isar
city: Münster
country: Germany
facility: Augenzentrum am St. Franziskus-Hospital
city: Münster
country: Germany
facility: Universitatsklinikum Regensburg
city: Münster
country: Germany
facility: Universitatsklinikum Munster
city: Tübingen
country: Germany
facility: STZ Eyetrial
city: Be'er Ya'akov
country: Israel
facility: Assaf ha Rofeh MC
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Milano
country: Italy
facility: IRCCS San Raffaele
city: Milano
country: Italy
facility: ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Radboud university medical center Oogheelkunde
city: Christchurch
country: New Zealand
facility: Southern Eye Specialists
city: Hamilton
country: New Zealand
facility: Hamilton Eye Clinic
city: Bydgoszcz
country: Poland
facility: Eye Surgery Center Professor Zagorski
city: Bydgoszcz
country: Poland
facility: Oftalmika Eye Hospital
city: Rzeszów
country: Poland
facility: Grupo Laser Vision
city: Tarnów
country: Poland
facility: Oculomedica Eye Centre
city: Tarnów
country: Poland
facility: UNO-MED Centrum Medyne
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Santiago De Compostela
country: Spain
facility: Instituto Oftalmologico Gomez-Ulla
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: St James's University Hospital
state: West Yorkshire
city: Bristol
country: United Kingdom
facility: Bristol Eye Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Kings College Hospital NHS Trust
city: London
country: United Kingdom
facility: London Vision Clinic
city: Oxford
country: United Kingdom
facility: Oxford Eye Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Eye Infirmary
Study officials:
References: