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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pegcetacoplan, 15 mg/100 μL, monthly for up to 36 months | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGCETACOPLAN (APL-2) | Drug | Complement (C3) Inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of ocular and systemic adverse events | Up to 36 Months |
| 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) |
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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.
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Research Institue, LLC | Phoenix | Arizona | 85014 | United States | ||
| Associated Retina Consultants, Ltd. |
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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 |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| California Retina Consultants | Bakersfield | California | 93309 | United States |
| Retinal Diagnostic Center | Campbell | California | 95508 | United States |
| The Retina Partners | Encino | California | 91436 | United States |
| Retina Consultants of Orange County | Fullerton | California | 92835 | United States |
| Atlantis Eyecare | Huntington Beach | California | 92647 | United States |
| Jacobs Retina Center, UCSD | La Jolla | California | 92093 | United States |
| Doheny Eye Center UCLA | Los Angeles | California | 90033 | United States |
| Northern California Retina Vitreous Associates | Mountain View | California | 94040 | United States |
| Retina Institute of California Medical Group | Palm Desert | California | 92260 | United States |
| Byers Eye Institute, Stanford University | Palo Alto | California | 94303 | United States |
| Retina Consultants San Diego | Poway | California | 92064 | United States |
| Orange County Retina Medical Group | Santa Ana | California | 92705 | United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Southwest Retina Research Center, LLC | Durango | Colorado | 81301 | United States |
| Danbury Eye Physicians & Surgeons, PC | Danbury | Connecticut | 06810 | United States |
| Retina Group of New England - New London | Waterford | Connecticut | 06835 | United States |
| Florida Eye Microsurgical Institute, Inc. | Boynton Beach | Florida | 33426 | United States |
| Blue Ocean Clinical Research | Clearwater | Florida | 33761 | United States |
| Pinnacle Research Insitute | Fort Lauderdale | Florida | 33309 | United States |
| Retina Health Center | Fort Myers | Florida | 33907 | United States |
| National Opthalmic Research Institute | Fort Myers | Florida | 33912 | United States |
| Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
| Bascom Palmer Eye Institute at Naples | Naples | Florida | 34103 | United States |
| Palm Beach Gardens | Palm Beach Gardens | Florida | 33418 | United States |
| Retina Specialty Institute | Pensacola | Florida | 32503 | United States |
| Eye Associates of Pinellas | Pinellas Park | Florida | 33782 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Retina Associates of Florida | Tampa | Florida | 33609 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | United States |
| Georgia Retina, PC | Marietta | Georgia | 30060 | United States |
| Gailey Eye Clinic Retina Center | Bloomington | Illinois | 61704 | United States |
| Northwestern Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Retina and Vitreous Associates of Kentucky, PSC dba Retina Associates of Kentucky | Lexington | Kentucky | 40509 | United States |
| The Retina Care Center | Baltimore | Maryland | 21209 | United States |
| Elman Retina Group | Baltimore | Maryland | 21236 | United States |
| The Retina Group of Washington | Chevy Chase | Maryland | 92705 | United States |
| Cumberland Valley Retina Center | Hagerstown | Maryland | 21740 | United States |
| Mid Atlantic Retina Specialist | Hagerstown | Maryland | 21740 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02116 | United States |
| New England Retina Consultants, PC | Springfield | Massachusetts | 01107 | United States |
| Michigan Medicine Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Associated Retinal Consultants, PC | Grand Rapids | Michigan | 49546 | United States |
| Associated Retinal Consultants, PC | Traverse City | Michigan | 49686 | United States |
| Vitreoretinal Surgery | Minneapolis | Minnesota | 55435 | United States |
| Sierra Eye Associates | Reno | Nevada | 89503 | United States |
| Retina Center of NJ, LLC | Bloomfield | New Jersey | 07003 | United States |
| NJ Retina | Teaneck | New Jersey | 07666 | United States |
| NJ Retina | Toms River | New Jersey | 08755 | United States |
| Vision Research Center Eye Associates of NM | Albuquerque | New Mexico | 87109 | United States |
| Long Island Vitreoretinal Consultants | Great Neck | New York | 11021 | United States |
| Vitreous Retina Macula Consultants of New York | New York | New York | 10022 | United States |
| Ophthalmic Consultants of Long Island | Oceanside | New York | 11572 | United States |
| Western Carolina Retinal Associates | Asheville | North Carolina | 28803 | United States |
| Charlotte Eye Ear Nose and Throat Associates, PS | Charlotte | North Carolina | 28210 | United States |
| Duke University, Duke Eye Center | Durham | North Carolina | 27710 | United States |
| Graystone Eye | Hickory | North Carolina | 28602 | United States |
| Retina Associates of Cleveland, Inc. | Cleveland | Ohio | 44122 | United States |
| Retina Associates of Cleveland | Cleveland | Ohio | 44130 | United States |
| Cleveland Clinic Cole Eye Institute | Cleveland | Ohio | 44195 | United States |
| The Ohio State University | Columbus | Ohio | 43212 | United States |
| Retina Associates of Cleveland, Inc. | Youngstown | Ohio | 44505 | United States |
| Retina Vitreous Center, PLLC | Edmond | Oklahoma | 73013 | United States |
| Oregon Retina LLP | Eugene | Oregon | 97405 | United States |
| Retina Northwest, PC | Portland | Oregon | 97221 | United States |
| Eye Health Northwest | Portland | Oregon | 97225 | United States |
| Mid Atlantic Retina | Bethlehem | Pennsylvania | 18107 | United States |
| Retina Vitreous Consultants | Monroeville | Pennsylvania | 15146 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19006 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| AIO Visionary Eye Care | West Mifflin | Pennsylvania | 15122 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Charles Retina Institute | Germantown | Tennessee | 38138 | United States |
| Tennessee Retina, PC | Nashville | Tennessee | 78503 | United States |
| Retina Research Center PLLC | Austin | Texas | 78750 | United States |
| Brown Retina Institute | Bellaire | Texas | 77401 | United States |
| Texas Retina Associates | Dallas | Texas | 75231 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Retina Consultants of Houston, PA | Houston | Texas | 77030 | United States |
| Valley Retina Institute | McAllen | Texas | 78503 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| Retina Associates of South Texas | San Antonio | Texas | 78240 | United States |
| Retina Consultants of Houston | The Woodlands | Texas | 77384 | United States |
| Retina Associates of Utah, PC | Murray | Utah | 84107 | United States |
| University of Utah - John A. Moran Center | Salt Lake City | Utah | 84312 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| The Retina Group of Washington | Fairfax | Virginia | 22031 | United States |
| Emerson Clinical Research Institute | Falls Church | Virginia | 22046 | United States |
| Vitreoretinal Associates of Washington | Bellevue | Washington | 98004 | United States |
| Spokane Eye Clinical Research | Spokane | Washington | 99204 | United States |
| Retina Health Center | Madison | Wisconsin | 53705 | United States |
| Retina-Vitreous Associates Medical Group | Madison | Wisconsin | 53705 | United States |
| Diagnostico Ocular | Buenos Aires | 1425 | Argentina |
| Organizacion Medica de Investigacion (OMI) | Buenos Aires | C1015 ABO | Argentina |
| Fundacion Zambrano | Buenos Aires | C1023 AAQ | Argentina |
| Centro Oftalmologico Dr. Charles S.A. | Buenos Aires | C1116ABA | Argentina |
| Instituto Oftalmologico de Cordoba | Córdoba | 5000 | Argentina |
| OFTAR | Mendoza | 5500 | Argentina |
| Microcirujia Ocular Rosario | Rosario | 2000 | Argentina |
| Oftalmologos Especialistas | Santa Fe | S2000 | Argentina |
| Marsden Eye Specialist | Parramatta | New South Wales | 2150 | Australia |
| Strathfield Retina Clinic | Strathfield | New South Wales | 2135 | Australia |
| Sydney Retina | Sydney | New South Wales | 2000 | Australia |
| The Ashley Centre | Westmead | New South Wales | 2145 | Australia |
| Centre for Eye Research Australia | East Melbourne | Victoria | 3002 | Australia |
| Retina and Eye Consultantss | Hurstville | 2220 | Australia |
| Lions Eye Institute | Nedlands | 6009 | Australia |
| Save Sight Institute | Westmead | 2145 | Australia |
| IPEPO Instituto Da Visao | São Paulo | 04038-032 | Brazil |
| Ivey Eye Institute | London | Ontario | N6A 4V2 | Canada |
| University of Ottawa Eye Institute | Ottawa | Ontario | K1H 8L6 | Canada |
| Retina Centre of Ottawa | Ottawa | Ontario | K2B 7E9 | Canada |
| Fakultni Nemocnice Ostrava | Ostrava-Poruba | 708 52 | Czechia |
| University hospital Kralovske Vinohrady | Prague | 10034 | Czechia |
| AXON Clinical, s.r.o. | Prague | 150 00 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 2128 08 | Czechia |
| Gemini Eye Clinic | Zlín | 760 01 | Czechia |
| Centre ophtalmologique Saint-Exupery | Saint-Cyr-sur-Loire | Lyon | 37540 | France |
| CHU de Bordeaux | Bordeaux | 33076 | France |
| Centre Hospitalier Intercommunal de Creteil | Créteil | 94010 | France |
| CHU Dijon | Dijon | 21 079 | France |
| Clinique du Val d'Ouest | Écully | 69130 | France |
| Hopital de la Croix-Rousse | Lyon | 69004 | France |
| Centre monticelli Paradis | Marseille | 13008 | France |
| CHU de Nantes - Hotel Dieu | Nantes | 44093 | France |
| Centre Ophtalmol de l Odeon | Paris | 75006 | France |
| Hopital Lariboisiere | Paris | 75010 | France |
| CHNO des Quinze-Vingts | Paris | 75012 | France |
| Centre Ophtalmo. Image/Laser | Paris | 75015 | France |
| Maison Rouge Ophthalmologic Center | Strasbourg | 67000 | France |
| CHU de Strasbourg Hopital Civil | Strasbourg | 67091 | France |
| Universitats-Augenklinik Bonn | Bonn | 53127 | Germany |
| Uniklinik Koln | Cologne | 50937 | Germany |
| University Opthalmology Clinic | Freiburg im Breisgau | 79106 | Germany |
| Uni-medizin Gottingen Augenklinik 3.B1.261 | Göttingen | 37075 | Germany |
| Klinikum der Stadt Ludwigshafen gGmbH | Ludwigshafen | 67063 | Germany |
| Universitatsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Augenklinik der LMU Munchen | München | 80336 | Germany |
| Klinikum rechts der Isar | München | 81675 | Germany |
| Augenzentrum am St. Franziskus-Hospital | Münster | 48145 | Germany |
| Universitatsklinikum Regensburg | Münster | 48145 | Germany |
| Universitatsklinikum Munster | Münster | 48149 | Germany |
| STZ Eyetrial | Tübingen | 72076 | Germany |
| Assaf ha Rofeh MC | Be’er Ya‘aqov | 7030000 | Israel |
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| Hadassah Medical Center | Jerusalem | 91120 | Israel |
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
| IRCCS San Raffaele | Milan | 20132 | Italy |
| ASST Fatebenefratelli-Sacco Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Academisch Medisch Centrum | Amsterdam | 1105 AZ | Netherlands |
| Radboud university medical center Oogheelkunde | Nijmegen | 6525 EX | Netherlands |
| Southern Eye Specialists | Christchurch | 8013 | New Zealand |
| Hamilton Eye Clinic | Hamilton | 3204 | New Zealand |
| Eye Surgery Center Professor Zagorski | Bydgoszcz | 85-316 | Poland |
| Oftalmika Eye Hospital | Bydgoszcz | 85-631 | Poland |
| Grupo Laser Vision | Rzeszów | 35-017 | Poland |
| Oculomedica Eye Centre | Tarnów | 33-100 | Poland |
| UNO-MED Centrum Medyne | Tarnów | 33-100 | Poland |
| Hospital Universitario Puerta de Hierro | Madrid | 28222 | Spain |
| Instituto Oftalmologico Gomez-Ulla | Santiago de Compostela | 15706 | Spain |
| Kings College Hospital NHS Trust | London | London | SE5 9RS | United Kingdom |
| Huddersfield Royal Infirmary | Huddersfield | West Yorkshire | HD3 3EA | United Kingdom |
| St James's University Hospital | Leeds | West Yorkshire | LS9 7TF | United Kingdom |
| Bristol Eye Hospital | Bristol | BS1 2LX | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| London Vision Clinic | London | W1G 7LA | United Kingdom |
| Oxford Eye Hospital | Oxford | OX3 9DU | United Kingdom |
| Sunderland Eye Infirmary | Sunderland | SR2 9HP | United Kingdom |
| ID | Term |
|---|---|
| C000716074 | pegcetacoplan |
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