Geographic Atrophy Secondary to Age-related Macular Degeneration Clinical Trial
— GALEOfficial 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
| Verified date | August 2023 |
| Source | Apellis Pharmaceuticals, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Active, not recruiting |
| Enrollment | 1200 |
| Est. completion date | September 2025 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 60 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Oftalmologico Dr. Charles S.A. | Buenos Aires | |
| Argentina | Diagnostico Ocular | Buenos Aires | |
| Argentina | Fundacion Zambrano | Buenos Aires | |
| Argentina | Organizacion Medica de Investigacion (OMI) | Buenos Aires | |
| Argentina | Instituto Oftalmologico de Cordoba | Córdoba | |
| Argentina | OFTAR | Mendoza | |
| Argentina | Microcirujia Ocular Rosario | Rosario | |
| Argentina | Oftalmologos Especialistas | Santa Fe | |
| Australia | Centre for Eye Research Australia | East Melbourne | Victoria |
| Australia | Retina and Eye Consultantss | Hurstville | |
| Australia | Lions Eye Institute | Nedlands | |
| Australia | Marsden Eye Specialist | Parramatta | New South Wales |
| Australia | Strathfield Retina Clinic | Strathfield | New South Wales |
| Australia | Sydney Retina | Sydney | New South Wales |
| Australia | Save Sight Institute | Westmead | |
| Australia | The Ashley Centre | Westmead | New South Wales |
| Brazil | IPEPO Instituto Da Visao | São Paulo | |
| Canada | Ivey Eye Institute | London | Ontario |
| Canada | Retina Centre of Ottawa | Ottawa | Ontario |
| Canada | University of Ottawa Eye Institute | Ottawa | Ontario |
| Czechia | Fakultni Nemocnice Ostrava | Ostrava-Poruba | |
| Czechia | AXON Clinical, s.r.o. | Prague | |
| Czechia | University hospital Kralovske Vinohrady | Prague | |
| Czechia | Vseobecna fakultni nemocnice v Praze | Praha | |
| Czechia | Gemini Eye Clinic | Zlín | |
| France | CHU de Bordeaux | Bordeaux | |
| France | Centre Hospitalier Intercommunal de Creteil | Créteil cedex | |
| France | CHU Dijon | Dijon | |
| France | Clinique du Val d'Ouest | Écully | |
| France | Hopital de la Croix-Rousse | Lyon | |
| France | Centre monticelli Paradis | Marseille | |
| France | CHU de Nantes - Hotel Dieu | Nantes Cedex | |
| France | Centre Ophtalmo. Image/Laser | Paris | |
| France | Centre Ophtalmol de l Odeon | Paris | |
| France | CHNO des Quinze-Vingts | Paris | |
| France | Hopital Lariboisiere | Paris | |
| France | Centre ophtalmologique Saint-Exupery | Saint-Cyr-sur-Loire | Lyon |
| France | CHU de Strasbourg Hopital Civil | Strasbourg | |
| France | Maison Rouge Ophthalmologic Center | Strasbourg | |
| Germany | Universitats-Augenklinik Bonn | Bonn | |
| Germany | Uniklinik Koln | Cologne | |
| Germany | University Opthalmology Clinic | Freiburg im Breisgau | |
| Germany | Uni-medizin Gottingen Augenklinik 3.B1.261 | Göttingen | |
| Germany | Universitatsklinikum Schleswig-Holstein | Lübeck | |
| Germany | Klinikum der Stadt Ludwigshafen gGmbH | Ludwigshafen | |
| Germany | Augenklinik der LMU Munchen | München | |
| Germany | Klinikum rechts der Isar | München | |
| Germany | Augenzentrum am St. Franziskus-Hospital | Münster | |
| Germany | Universitatsklinikum Munster | Münster | |
| Germany | Universitatsklinikum Regensburg | Münster | |
| Germany | STZ Eyetrial | Tübingen | |
| Israel | Assaf ha Rofeh MC | Be'er Ya'akov | |
| Israel | Rambam Health Care Campus | Haifa | |
| Israel | Hadassah Medical Center | Jerusalem | |
| Israel | Tel Aviv Sourasky Medical Center | Tel Aviv | |
| Italy | ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco | Milano | |
| Italy | IRCCS San Raffaele | Milano | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | |
| Netherlands | Radboud university medical center Oogheelkunde | Nijmegen | |
| New Zealand | Southern Eye Specialists | Christchurch | |
| New Zealand | Hamilton Eye Clinic | Hamilton | |
| Poland | Eye Surgery Center Professor Zagorski | Bydgoszcz | |
| Poland | Oftalmika Eye Hospital | Bydgoszcz | |
| Poland | Grupo Laser Vision | Rzeszów | |
| Poland | Oculomedica Eye Centre | Tarnów | |
| Poland | UNO-MED Centrum Medyne | Tarnów | |
| Spain | Hospital Universitario Puerta de Hierro | Madrid | |
| Spain | Instituto Oftalmologico Gomez-Ulla | Santiago De Compostela | |
| United Kingdom | Bristol Eye Hospital | Bristol | |
| United Kingdom | Huddersfield Royal Infirmary | Huddersfield | West Yorkshire |
| United Kingdom | St James's University Hospital | Leeds | West Yorkshire |
| United Kingdom | Royal Liverpool University Hospital | Liverpool | |
| United Kingdom | Kings College Hospital NHS Trust | London | |
| United Kingdom | London Vision Clinic | London | |
| United Kingdom | Oxford Eye Hospital | Oxford | |
| United Kingdom | Sunderland Eye Infirmary | Sunderland | |
| United States | Vision Research Center Eye Associates of NM | Albuquerque | New Mexico |
| United States | Michigan Medicine Kellogg Eye Center | Ann Arbor | Michigan |
| United States | Western Carolina Retinal Associates | Asheville | North Carolina |
| United States | Southeast Retina Center, PC | Augusta | Georgia |
| United States | Retina Research Center PLLC | Austin | Texas |
| United States | California Retina Consultants | Bakersfield | California |
| United States | Elman Retina Group | Baltimore | Maryland |
| United States | The Retina Care Center | Baltimore | Maryland |
| United States | Brown Retina Institute | Bellaire | Texas |
| United States | Vitreoretinal Associates of Washington | Bellevue | Washington |
| United States | Mid Atlantic Retina | Bethlehem | Pennsylvania |
| United States | Retina Center of NJ, LLC | Bloomfield | New Jersey |
| United States | Gailey Eye Clinic Retina Center | Bloomington | Illinois |
| United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Florida Eye Microsurgical Institute, Inc. | Boynton Beach | Florida |
| United States | Retinal Diagnostic Center | Campbell | California |
| United States | Charlotte Eye Ear Nose and Throat Associates, PS | Charlotte | North Carolina |
| United States | University of Virginia | Charlottesville | Virginia |
| United States | The Retina Group of Washington | Chevy Chase | Maryland |
| United States | Northwestern Feinberg School of Medicine | Chicago | Illinois |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Blue Ocean Clinical Research | Clearwater | Florida |
| United States | Cleveland Clinic Cole Eye Institute | Cleveland | Ohio |
| United States | Retina Associates of Cleveland | Cleveland | Ohio |
| United States | Retina Associates of Cleveland, Inc. | Cleveland | Ohio |
| United States | The Ohio State University | Columbus | Ohio |
| United States | Texas Retina Associates | Dallas | Texas |
| United States | Danbury Eye Physicians & Surgeons, PC | Danbury | Connecticut |
| United States | Southwest Retina Research Center, LLC | Durango | Colorado |
| United States | Duke University, Duke Eye Center | Durham | North Carolina |
| United States | Retina Vitreous Center, PLLC | Edmond | Oklahoma |
| United States | The Retina Partners | Encino | California |
| United States | Oregon Retina LLP | Eugene | Oregon |
| United States | The Retina Group of Washington | Fairfax | Virginia |
| United States | Emerson Clinical Research Institute | Falls Church | Virginia |
| United States | Pinnacle Research Insitute | Fort Lauderdale | Florida |
| United States | National Opthalmic Research Institute | Fort Myers | Florida |
| United States | Retina Health Center | Fort Myers | Florida |
| United States | Retina Consultants of Orange County | Fullerton | California |
| United States | Charles Retina Institute | Germantown | Tennessee |
| United States | Associated Retinal Consultants, PC | Grand Rapids | Michigan |
| United States | Long Island Vitreoretinal Consultants | Great Neck | New York |
| United States | Cumberland Valley Retina Center | Hagerstown | Maryland |
| United States | Mid Atlantic Retina Specialist | Hagerstown | Maryland |
| United States | Graystone Eye | Hickory | North Carolina |
| United States | Houston Eye Associates | Houston | Texas |
| United States | Retina Consultants of Houston, PA | Houston | Texas |
| United States | Atlantis Eyecare | Huntington Beach | California |
| United States | Midwest Eye Institute | Indianapolis | Indiana |
| United States | Jacobs Retina Center, UCSD | La Jolla | California |
| United States | Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky | Lexington | Kentucky |
| United States | Doheny Eye Center UCLA | Los Angeles | California |
| United States | Retina Health Center | Madison | Wisconsin |
| United States | Retina-Vitreous Associates Medical Group | Madison | Wisconsin |
| United States | Sara Gater | Manchester | New Hampshire |
| United States | Georgia Retina, PC | Marietta | Georgia |
| United States | Valley Retina Institute | McAllen | Texas |
| United States | Bascom Palmer Eye Institute | Miami | Florida |
| United States | Vitreoretinal Surgery | Minneapolis | Minnesota |
| United States | Retina Vitreous Consultants | Monroeville | Pennsylvania |
| United States | Northern California Retina Vitreous Associates | Mountain View | California |
| United States | Retina Associates of Utah, PC | Murray | Utah |
| United States | Bascom Palmer Eye Institute at Naples | Naples | Florida |
| United States | Tennessee Retina, PC | Nashville | Tennessee |
| 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 | Palm Beach Gardens | Palm Beach Gardens | Florida |
| United States | Retina Institute of California Medical Group | Palm Desert | California |
| United States | Byers Eye Institute, Stanford University | Palo Alto | California |
| United States | Retina Specialty Institute | Pensacola | Florida |
| United States | Mid Atlantic Retina | Philadelphia | Pennsylvania |
| United States | Mid Atlantic Retina | Philadelphia | Pennsylvania |
| United States | Associated Retina Consultants, Ltd. | Phoenix | Arizona |
| United States | Retinal Research Institue, LLC | Phoenix | Arizona |
| United States | Eye Associates of Pinellas | Pinellas Park | Florida |
| United States | Eye Health Northwest | Portland | Oregon |
| United States | Retina Northwest, PC | Portland | Oregon |
| United States | Retina Consultants San Diego | Poway | California |
| United States | Black Hills Regional Eye Institute | Rapid City | South Dakota |
| United States | Sierra Eye Associates | Reno | Nevada |
| United States | University of Utah - John A. Moran Center | Salt Lake City | Utah |
| United States | Medical Center Ophthalmology Associates | San Antonio | Texas |
| United States | Retina Associates of South Texas | San Antonio | Texas |
| United States | Orange County Retina Medical Group | Santa Ana | California |
| United States | California Retina Consultants | Santa Barbara | California |
| United States | Spokane Eye Clinical Research | Spokane | Washington |
| United States | New England Retina Consultants, PC | Springfield | Massachusetts |
| 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 | NJ Retina | Teaneck | New Jersey |
| United States | Retina Consultants of Houston | The Woodlands | Texas |
| United States | NJ Retina | Toms River | New Jersey |
| United States | Associated Retinal Consultants, PC | Traverse City | Michigan |
| United States | Bay Area Retina Associates | Walnut Creek | California |
| United States | Retina Group of New England - New London | Waterford | Connecticut |
| United States | AIO Visionary Eye Care | West Mifflin | Pennsylvania |
| United States | Center for Retina and Macular Disease | Winter Haven | Florida |
| United States | Retina Associates of Cleveland, Inc. | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Apellis Pharmaceuticals, Inc. |
United States, Argentina, Australia, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, New Zealand, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence and severity of ocular and systemic adverse events | Up to 36 Months | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |