Geographic Atrophy Clinical Trial
Official title:
A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study
| Verified date | January 2019 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.
| Status | Terminated |
| Enrollment | 994 |
| Est. completion date | January 31, 2018 |
| Est. primary completion date | January 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Previous enrollment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531) with completion of treatment and the Week 96 visit - Agreement to remain abstinent or use a reliable form of contraception among all men and among women of child-bearing potential Exclusion Criteria: - Concurrent ocular conditions that contraindicate use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications - Concurrent disease, metabolic dysfunction, or physical or laboratory finding that contraindicates use of lampalizumab or might affect interpretation of study results or that might increase the risk of treatment complications - Increased risk of infection - Pregnancy or lactation |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Eyeclinic Albury Wodonga | Albury | New South Wales |
| Australia | Vision Eye Institute Eastern | Box Hill | Victoria |
| Australia | Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria |
| Australia | Marsden Eye Research Centre | Parramatta | New South Wales |
| Australia | Save Sight Institute | Sydney | New South Wales |
| Australia | Sydney West Retina | Westmead | New South Wales |
| Austria | Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde | Linz | |
| Austria | Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie | Wien | |
| Belgium | CHU Brugmann (Victor Horta) | Bruxelles | |
| Belgium | UZ Leuven Sint Rafael | Leuven | |
| Canada | Institut De L'Oeil Des Laurentides | Boisbriand | Quebec |
| Denmark | Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37 | Glostrup | |
| Denmark | Sjællands Universitetshospital, Roskilde; Øjenafdelingen | Roskilde | |
| France | Hopital Pellegrin; Ophtalmologie | Bordeaux | |
| France | Chi De Creteil; Ophtalmologie | Creteil | |
| France | Hôpital de La Croix Rousse | Lyon | |
| France | Centre Monticelli Paradis d Ophtalmologie | Marseille | |
| France | CHU Nantes - Hôtel Dieu; Ophthalmology | Nantes | |
| France | Centre Odeon; Exploration Ophtalmologique | Paris | |
| France | CHNO des Quinze Vingts; Ophtalmologie | Paris | |
| Germany | Universitäts-Augenklinik Bonn | Bonn | |
| Germany | Universitätsklinikum Freiburg, Klinik für Augenheilkunde | Freiburg | |
| Germany | Medizinische Hochschule Hannover, Klinik für Augenheilkunde | Hannover | |
| Germany | Universitätsklinik Heidelberg; Augenklinik | Heidelberg | |
| Germany | Universitätsklinikum Köln; Augenklinik | Köln | |
| Germany | Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde | Lübeck | |
| Germany | Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik | Ludwigshafen | |
| Germany | Klinikum rechts der Isar der TU München; Augenklinik | München | |
| Germany | LMU Klinikum der Universität, Augenklinik | München | |
| Germany | Augenabteilung am St. Franziskus-Hospital | Münster | |
| Germany | Universitätsklinikum Münster; Augenheilkunde | Münster | |
| Germany | Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde | Regensburg | |
| Germany | Universitätsklinikum Tübingen | Tuebingen | |
| Hungary | Budapest Retina Associates Kft. | Budapest | |
| Hungary | Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR | Budapest | |
| Hungary | Semmelweis Egyetem AOK, Szemeszeti Klinika | Budapest | |
| Hungary | Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika | Debrecem | |
| Hungary | Ganglion Medial Center | Pecs | |
| Italy | UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA | Genova | Liguria |
| Italy | ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco) | Milano | Lombardia |
| Italy | Irccs Ospedale San Raffaele;U.O. Oculistica | Milano | Lombardia |
| Italy | Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche | Roma | Lazio |
| Italy | A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico | Torino | Piemonte |
| Italy | A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica | Udine | Veneto |
| Netherlands | Leids Universitair Medisch Centrum | Leiden | |
| Peru | TG Laser Oftalmica | Lima | |
| Poland | OFTALMIKA Sp. z o.o | Bydgoszcz | |
| Poland | Szpital Specjalistyczny nr 1; Oddzial Okulistyki | Bytom | |
| Poland | Optimum Profesorskie Centrum Okulistyki | Gdansk | |
| Poland | Gabinet Okulistyczny Prof Edward Wylegala | Katowice | |
| Poland | SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Okulistyki i Onkologii Okulistycznej | Krakow | |
| Poland | Klinika Okulistyczna Jasne Blonia | Lódz | |
| Poland | Uniwersytecki Szpital Kliniczny; Klinika Okulistyki | Wroclaw | |
| Portugal | AIBILI - Association for Innovation and Biomedical Research on Light | Coimbra | |
| Portugal | Espaco Medico Coimbra | Coimbra | |
| Portugal | Hospital de Santa Maria; Servico de Oftalmologia | Lisboa | |
| Slovakia | Nemocnica sv. Michala, a.s. | Bratislava | |
| Slovakia | Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB | Bratislava | |
| Slovakia | Fakultna nemocnica Trencin Ocna klinika | Trencin | |
| Slovakia | Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie | Zilina | |
| Spain | Hospital Perpetuo Socorro; Servicio de Oftalmología | Albacete | |
| Spain | Institut de la Macula i la retina | Barcelona | |
| Spain | Instituto de microcirugia ocular | Barcelona | |
| Spain | Instituto Clinico Quirurgico de Oftalmologia - ICQO | Bilbao | Guipuzcoa |
| Spain | Hospital Universitari de Bellvitge; Servicio de Oftalmologia | Hospitalet De Llobregat | Barcelona |
| Spain | VISSUM Madrid Santa Hortensia | Madrid | |
| Spain | Clinica Universitaria de Navarra; Servicio de Oftalmologia | Pamplona | Navarra |
| Spain | Instituto Oftalmologico Gomez Ulla | Santiago de Compostela | LA Coruña |
| Spain | FISABIO. Fundación Oftalmologica del Mediterraneo | Valencia | |
| Spain | Hospital Universitario Rio Hortega; Servicio de Oftalmologia | Valladolid | |
| Switzerland | Inselspital Bern, Universitätsklinik für Augenheilkunde | Bern | |
| Switzerland | Vista Klinik Binningen | Binningen | |
| Switzerland | Stadtspital Triemli; Augenklinik | Zürich | |
| Turkey | Baskent University Ankara Hospital | Ankara | |
| Turkey | Hacettepe University Medical Faculty | Ankara | |
| United Kingdom | Royal Victoria Hospital | Belfast | |
| United Kingdom | Bradford Royal Infirmary | Bradford | |
| United Kingdom | Bristol Eye Hospital | Bristol | |
| United Kingdom | University Hospital of Wales | Cardiff | |
| United Kingdom | Gloucestershire Hospitals NHS Foundation Trust | Gloucestershire | |
| United Kingdom | Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre | Liverpool | |
| United Kingdom | Macular Treatment Centre; Royal Eye Hospital | Manchester | |
| United Kingdom | Royal Victoria Infirmary | Newcastle upon Tyne | |
| United Kingdom | Southampton General Hospital | Southampton | |
| United Kingdom | The Royal Wolverhampton Hospitals NHS Trust | Wolverhampton | |
| United Kingdom | The York Hospital | York | |
| United States | Retina Consultants of Hawaii | 'Aiea | Hawaii |
| United States | Retina Res Institute of Texas | Abilene | Texas |
| United States | Lions Eye Institute | Albany | New York |
| United States | University of Michigan, Kellogg Eye Center | Ann Arbor | Michigan |
| United States | Texas Retina Associates | Arlington | Texas |
| United States | West Carolina Retinal AssocPA | Asheville | North Carolina |
| United States | Retina & Vitreous Center of Southern Oregon | Ashland | Oregon |
| United States | Southeast Retina Center | Augusta | Georgia |
| United States | University of Colorado | Aurora | Colorado |
| United States | Austin Retina Associates | Austin | Texas |
| United States | Retina Research Center | Austin | Texas |
| United States | California Retina Consultants | Bakersfield | California |
| United States | The Retina Care Center | Baltimore | Maryland |
| United States | Wilmer Eye Institute | Baltimore | Maryland |
| United States | Vitreoretinal Associates of Washington | Bellevue | Washington |
| United States | Retina-Vitreous Associates Medical Group | Beverly Hills | California |
| United States | Uni of Alabama At Birmingham Clinical Research Unit | Birmingham | Alabama |
| United States | Retina Center of New Jersey | Bloomfield | New Jersey |
| United States | Mass Eye and Ear Infirmary | Boston | Massachusetts |
| United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
| United States | Tufts Medical Center Research | Boston | Massachusetts |
| United States | Florida Eye Microsurgical Inst | Boynton Beach | Florida |
| United States | Char Eye Ear &Throat Assoc | Charlotte | North Carolina |
| United States | Univ of Virginia Ophthalmology | Charlottesville | Virginia |
| United States | Southeastern Retina Associates Chattanooga | Chattanooga | Tennessee |
| United States | Mid Atlantic Retina - Wills Eye Hospital | Cherry Hill | New Jersey |
| United States | Lifelong Vision Foundation | Chesterfield | Missouri |
| United States | Retina Group of Washington | Chevy Chase | Maryland |
| United States | Cincinnati Eye Institute | Cincinnati | Ohio |
| United States | Cleveland Clinic Foundation; Cole Eye Institute | Cleveland | Ohio |
| United States | Retina Assoc of Cleveland Inc | Cleveland | Ohio |
| United States | Retina Consultants of Southern | Colorado Springs | Colorado |
| United States | OSU Eye Physicians & Surgeons | Columbus | Ohio |
| United States | Texas Retina Associates | Dallas | Texas |
| United States | Kresge Eye Institute | Detroit | Michigan |
| United States | Duke University Eye Center; Vitreoretinal | Durham | North Carolina |
| United States | Vitreoretinal Surgery | Edina | Minnesota |
| United States | New Jersey Retina Research Foundation | Edison | New Jersey |
| United States | Palmetto Retina Center | Florence | South Carolina |
| United States | Retina Group of Florida | Fort Lauderdale | Florida |
| United States | National Ophthalmic 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 Institution | Germantown | Tennessee |
| United States | Colorado Retina Associates, PC | Golden | Colorado |
| United States | Vitreo-Retinal Associates | Grand Rapids | Michigan |
| United States | Long Is. Vitreoretinal Consult | Hauppauge | New York |
| United States | Retina Consultants of Houston | Houston | Texas |
| United States | Midwest Eye Institute Northside | Indianapolis | Indiana |
| United States | Specialty Eye Institute | Jackson | Michigan |
| United States | UCSD Shiley Eye Center | La Jolla | California |
| United States | Charleston Neuroscience Inst | Ladson | South Carolina |
| United States | Retina Consultants of Nevada | Las Vegas | Nevada |
| United States | Delaware Valley Retina Assoc | Lawrenceville | New Jersey |
| United States | Lahey Clinic Med Ctr | Lexington | Kentucky |
| United States | Retina Associates of Kentucky | Lexington | Kentucky |
| United States | Jules Stein Eye Institute/ UCLA | Los Angeles | California |
| United States | Opthalmic Consultants of LI | Lynbrook | New York |
| United States | University of Wisconsin | Madison | Wisconsin |
| United States | Georgia Retina PC | Marietta | Georgia |
| United States | Valley Retina Institute P.A. | McAllen | Texas |
| United States | Florida Eye Associates | Melbourne | Florida |
| United States | Retina Vitreous Consultants | Monroeville | Pennsylvania |
| United States | West Virginia University Eye Institute | Morgantown | West Virginia |
| United States | N CA Retina Vitreous Assoc | Mountain View | California |
| United States | Bascom Palmer Eye Institute | Naples | Florida |
| United States | Tennessee Retina PC. | Nashville | Tennessee |
| United States | Retina Group of New England | New London | Connecticut |
| United States | New York Eye & Ear Infirmary | New York | New York |
| United States | Vitreous-Retina-Macula | New York | New York |
| United States | Retinal & Ophthalmic Cons PC | Northfield | New Jersey |
| United States | East Bay Retina Consultants | Oakland | California |
| United States | Paducah Retinal Center | Paducah | Kentucky |
| United States | Bascom Palmer Eye Institute | Palm Beach Gardens | Florida |
| United States | Retina Care Specialists | Palm Beach Gardens | Florida |
| United States | Southern CA Desert Retina Cons | Palm Desert | California |
| United States | Byers Eye Insitute at Stanford | Palo Alto | California |
| United States | Retina Specialty Institute | Pensacola | Florida |
| United States | Mid Atlantic Retina | Philadelphia | Pennsylvania |
| United States | Associated Retina Consultants | Phoenix | Arizona |
| United States | Retinal Research Institute, LLC | Phoenix | Arizona |
| United States | Fort Lauderdale Eye Institute | Plantation | Florida |
| United States | Maine Eye Center | Portland | Maine |
| United States | Oregon HSU; Casey Eye Institute | Portland | Oregon |
| United States | Retina Northwest | Portland | Oregon |
| United States | Retina Consultants, San Diego | Poway | California |
| United States | Black Hills Eye Institute | Rapid City | South Dakota |
| United States | Sierra Eye Associates | Reno | Nevada |
| United States | Eye Surgeons of Richmond Inc. dba Virginia Eye Institute | Richmond | Virginia |
| United States | Retina Institute of Virginia | Richmond | Virginia |
| United States | Retina Assoc of Western NY | Rochester | New York |
| United States | Assoc Retinal Consultants PC | Royal Oak | Michigan |
| United States | Retinal Consultants Med Group | Sacramento | California |
| United States | University of California, Davis, Eye Center | Sacramento | California |
| United States | Retina Vitreous Assoc of FL | Saint Petersburg | Florida |
| United States | Retina Associates of Utah | Salt Lake City | Utah |
| United States | UCSF Comprehensive Cancer Ctr; Ophthalmology | San Francisco | California |
| United States | W Coast Retina Med Group Inc | San Francisco | California |
| United States | Orange County Retina Med Group | Santa Ana | California |
| United States | California Retina Consultants | Santa Barbara | California |
| United States | Retina Associates | Shawnee Mission | Kansas |
| United States | Retina Center Northwest | Silverdale | Washington |
| United States | Retina Consultants of Michigan | Southfield | Michigan |
| United States | Spokane Eye Clinical Research | Spokane | Washington |
| United States | Retina Vit Surgeons/Central NY | Syracuse | New York |
| United States | Southern Vitreoretinal Assoc | Tallahassee | Florida |
| United States | Retina Associates of Florida, LLC | Tampa | Florida |
| United States | University of South Florida | Tampa | Florida |
| United States | Retina Associates of NJ | Teaneck | New Jersey |
| United States | Scott and White Hospital | Temple | Texas |
| United States | Retina Consultants of Houston | The Woodlands | Texas |
| United States | Retina Specialists | Towson | Maryland |
| United States | Retina Associates Southwest PC | Tucson | Arizona |
| United States | Retina Centers P.C. | Tucson | Arizona |
| United States | Bay Area Retina Associates | Walnut Creek | California |
| United States | Virginia Retina Center | Warrenton | Virginia |
| United States | Wolfe Eye Clinic | West Des Moines | Iowa |
| United States | Associates in Ophthalmology | West Mifflin | Pennsylvania |
| United States | Vitreo Retinal Consultants | Wichita | Kansas |
| United States | Strategic Clinical Research Group, LLC | Willow Park | Texas |
| United States | Wake Forest Baptist Health Eye Centre | Winston-Salem | North Carolina |
| United States | Vitreo-Retinal Associates, PC | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
United States, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hungary, Italy, Netherlands, Peru, Poland, Portugal, Slovakia, Spain, Switzerland, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Ocular Adverse Events (AEs) by Severity | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. Ocular AEs are the events which are localized in the ocular region. | Up to approximately one year | |
| Primary | Percentage of Participants With Systemic (Non-Ocular) AEs by Severity | An AE was defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether considered related to the medicinal product, any new disease or exacerbation of an existing disease, recurrence of an intermittent medical condition, or any deterioration in a laboratory value or other clinical test. | Up to approximately one year | |
| Primary | Percentage of Participants With Anti-Lampalizumab Antibodies | The immunogenicity analysis included participants with at least one predose and one postdose anti-lampalizumab antibodies assessment. Predose was defined as prior to the first dose in the extension study for the prior sham participants, and prior to the first dose in the parent study for the prior lampalizumab participants. | Week 48 |
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