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Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Sponsor: AbbVie
Summary
Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD). Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide. Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Official title: A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
561
Start Date
2025-11-05
Completion Date
2033-03
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
Surabgene Lomparvovec (ABBV-RGX-314)
subretinal injection
Ranibizumab Control
intravitreal injection
Locations (96)
Barnet Dulaney Perkins Eye Centers /ID# 279265
Mesa, Arizona, United States
American Vision Partners /ID# 264615
Sun City, Arizona, United States
Retinal Diagnostic Center /ID# 263054
Campbell, California, United States
The Retina Partners /ID# 263265
Encino, California, United States
Retina Associates of Southern California /ID# 263056
Huntington Beach, California, United States
Retina Consultants of San Diego /ID# 264026
Poway, California, United States
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
Sacramento, California, United States
Orange County Retina Medical Group /ID# 266612
Santa Ana, California, United States
Retina Consultants of Southern Colorado /ID# 263284
Colorado Springs, Colorado, United States
Colorado Retina Associates /ID# 263247
Lakewood, Colorado, United States
Advanced Vision Surgery Center /ID# 264208
Longmont, Colorado, United States
Advanced Research, LLC /ID# 276526
Deerfield Beach, Florida, United States
Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
Fort Myers, Florida, United States
Florida Retina Institute - Lake Mary /ID# 263288
Lake Mary, Florida, United States
Southeast Retina Center /ID# 263264
Augusta, Georgia, United States
Springfield Clinic Main Campus /ID# 265202
Springfield, Illinois, United States
Midwest Eye Institute North Indianapolis /ID# 264031
Carmel, Indiana, United States
Wolfe Eye Clinic - West Des Moines /ID# 263270
West Des Moines, Iowa, United States
The Retina Care Center /ID# 263263
Baltimore, Maryland, United States
Retina Specialist /ID# 264633
Towson, Maryland, United States
Associated Retinal Consultants /ID# 263289
Royal Oak, Michigan, United States
Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427
Edina, Minnesota, United States
Mayo Clinic - Minnesota /ID# 263977
Rochester, Minnesota, United States
Retina Institute - St. Louis /ID# 263985
St Louis, Missouri, United States
Midwest Retina /ID# 263231
Dublin, Ohio, United States
Erie Retina Research /ID# 263287
Erie, Pennsylvania, United States
Charleston Neuroscience Institute /ID# 264037
Bluffton, South Carolina, United States
Charleston Neuroscience Institute /ID# 276425
Charleston, South Carolina, United States
Retina Consultants of South Carolina - Ladson /ID# 277596
Ladson, South Carolina, United States
Retina Consultants of America /ID# 264038
Mt. Pleasant, South Carolina, United States
Austin Retina Associates - Austin /ID# 266770
Austin, Texas, United States
Austin Clinical Research, LLC /ID# 263229
Austin, Texas, United States
Star Retina /ID# 266386
Burleson, Texas, United States
Retina Consultants of Texas - Westover /ID# 264209
San Antonio, Texas, United States
Rocky Mountain Retina Consultants /ID# 263266
Murray, Utah, United States
Medizinische Universitaet Graz /ID# 264511
Graz, Styria, Austria
Medizinische Universitaet Innsbruck /ID# 264502
Innsbruck, Tyrol, Austria
Kepler Universitaetsklinikum GmbH /ID# 264493
Linz, Upper Austria, Austria
UZ Gent /ID# 261300
Ghent, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 261302
Leuven, Vlaams-Brabant, Belgium
Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729
Burgas, Bulgaria
OCIPSMAED St. Luka /ID# 275727
Plovdiv, Bulgaria
Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730
Sofia, Bulgaria
Medical Center -Vereya /ID# 275728
Stara Zagora, Bulgaria
Retina Centre of Ottawa /ID# 263803
Ottawa, Ontario, Canada
Specijalna bolnica Svjetlost /ID# 276051
Zagreb, City of Zagreb, Croatia
Fakultni nemocnice Kralovske Vinohrady /ID# 264660
Prague, Czechia
Hopital Edouard Herriot /ID# 265072
Lyon, Auvergne-Rhône-Alpes, France
CHU Bordeaux - Hopital Pellegrin /ID# 265123
Bordeaux, Nouvelle-Aquitaine, France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu /ID# 265077
Nantes, Pays de la Loire Region, France
Centre Hospitalier Intercommunal de Creteil /ID# 265080
Créteil, Val-de-Marne, France
Hôpital Fondation Adolphe de Rothschild /ID# 265081
Paris, France
Centre Hospitalier National d'Ophtalmologie Quinze-Vingts /ID# 265125
Paris, Île-de-France Region, France
Universitaetsklinikum Freiburg /ID# 275449
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitaetsklinikum Tuebingen /ID# 264283
Tübingen, Baden-Wurttemberg, Germany
LMU Klinikum - Campus Innenstadt /ID# 264285
Munich, Bavaria, Germany
Universitaetsmedizin Goettingen - Georg-August-Universitaet /ID# 264282
Göttingen, Lower Saxony, Germany
Medizinische Hochschule Hannover /ID# 264281
Hanover, Lower Saxony, Germany
Universitaetsklinikum Bonn /ID# 264279
Bonn, North Rhine-Westphalia, Germany
Klinikum Ludwigshafen /ID# 275448
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284
Lübeck, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 266366
Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 264280
Hamburg, Germany
University General Hospital Attikon /ID# 264914
Athens, Attica, Greece
University General Hospital of Larissa /ID# 264247
Larissa, Greece
Ganglion Orvosi Kozpont /ID# 265210
Pécs, Baranya, Hungary
Debreceni Egyetem-Klinikai Kozpont /ID# 265453
Debrecen, Hajdú-Bihar, Hungary
Budapest Retina Associates /ID# 265208
Budapest, Hungary
Edith Wolfson Medical Center /ID# 266304
Holon, Central District, Israel
Rabin Medical Center /ID# 266449
Petah Tikva, Central District, Israel
Kaplan Medical Center /ID# 264399
Rehovot, Central District, Israel
Yitzhak Shamir Medical Center /ID# 275679
Ẕerifin, Central District, Israel
The Chaim Sheba Medical Center /ID# 264700
Ramat Gan, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 266246
Tel Aviv, Tel Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 264300
Jerusalem, Israel
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 276017
Cona, Ferrara, Italy
Azienda Ospedaliero Universitaria Careggi /ID# 265739
Florence, Firenze, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 276032
Rome, Roma, Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 265305
Ancona, Italy
Unidade Local de Saude de Coimbra, EPE /ID# 264657
Coimbra, Portugal
Unidade Local de Saude de Sao Jose, EPE /ID# 264655
Lisbon, Portugal
Emanuelli Research & Development Center /ID# 264350
Arecibo, Puerto Rico
Hospital Arruzafa /ID# 280175
Córdoba, Cordoba, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179
Majadahonda, Madrid, Spain
Instituto Oftalmológico Fernández-Vega /ID# 263157
Asturias, Principality of Asturias, Spain
Centre d'Oftalmologia Barraquer /ID# 266631
Barcelona, Spain
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152
Barcelona, Spain
Hospital Universitari Vall d'Hebron /ID# 263301
Barcelona, Spain
Hospital Universitario 12 de Octubre /ID# 263544
Madrid, Spain
Hospital Clinico Universitario Lozano Blesa /ID# 263158
Zaragoza, Spain
Gloucestershire Royal Hospital /ID# 276072
Gloucester, Gloucestershire, United Kingdom
Moorfields Eye Hospital /ID# 267227
London, Greater London, United Kingdom
The Retina Clinic London /ID# 266156
London, Greater London, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 265854
Liverpool, Merseyside, United Kingdom
Bristol Eye Hospital /ID# 266155
Bristol, United Kingdom
Sunderland Royal Hospital /ID# 266664
Sunderland, United Kingdom