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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07007065

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Surabgene Lomparvovec (ABBV-RGX-314) (Drug)
    subretinal injection
  • Ranibizumab Control (Drug)
    intravitreal injection

Eligibility criteria

Inclusion Criteria: * Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \[Week -6\]) in the study eye. * Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\^2) * Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator) Exclusion Criteria: * CNV or macular edema in the study eye that is secondary to any causes other than AMD * Study eye with nAMD diagnosed \> 4 years from Screening Visit 1 * Any retinal pigment epithelial detachment \> 400 μm or any pigment epithelial detachment \> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center. * Any subretinal hemorrhage in the study eye \> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center * Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.

Conditions

Neovascular Age-related Macular Degeneration

Locations

  • Barnet Dulaney Perkins Eye Center - Mesa /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
  • Shiley Eye Institute At Uc San Diego Health /ID# 276682 — La Jolla, California, United States
  • Northern California Retina Vitreous Associates - Mountain View /ID# 263990 — Mountain View, California, United States
  • Eye Research Foundation /ID# 277345 — Newport Beach, California, United States
  • Retina Consultants of San Diego /ID# 264026 — Poway, California, United States
  • Retina Consultants Of Southern California - Redlands /ID# 276496 — Redlands, California, United States
  • Kaiser Permanente - Riverside Medical Center /ID# 263253 — Riverside, California, United States
  • Retinal Consultants - Sacramento - Greenback Lane /ID# 263983 — Sacramento, California, United States
  • UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058 — San Francisco, 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
  • Segal Drug Trials, Inc /ID# 276966 — Delray 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 - Orlando /ID# 263288 — Orlando, Florida, United States
  • Center for Retina and Macular Disease /ID# 264201 — Winter Haven, Florida, United States
  • Southeast Retina Center /ID# 263264 — Augusta, Georgia, United States
  • Vision Medical Research /ID# 277102 — Oak Lawn, Illinois, 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
  • Retina Associates - Lenexa /ID# 264607 — Lenexa, Kansas, United States
  • Maine Eye Center - Marginal Way Campus /ID# 263251 — Portland, Maine, 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
  • Sierra Eye Associates /ID# 263240 — Reno, Nevada, United States
  • Monmouth Retina Consultants /ID# 279252 — Little Silver, New Jersey, United States
  • Cleveland Clinic - Cleveland /ID# 264210 — Cleveland, Ohio, United States
  • Ohio State Havener Eye Institute - Columbus /ID# 263987 — Columbus, Ohio, United States
  • Midwest Retina /ID# 263231 — Dublin, Ohio, United States
  • Erie Retina Research /ID# 263287 — Erie, Pennsylvania, United States
  • Mid Atlantic Retina - Philadelphia /ID# 263291 — Philadelphia, Pennsylvania, United States
  • Charleston Neuroscience Institute - Bluffton /ID# 264037 — Bluffton, South Carolina, United States
  • Charleston Neuroscience Institute - Charleston /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
  • Black Hills Regional Eye Institute /ID# 279258 — Rapid City, South Dakota, United States
  • Retina Research Institute of Texas /ID# 263233 — Abilene, Texas, 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 /ID# 263274 — Houston, Texas, United States
  • Austin Retina Associates - Round Rock /ID# 266776 — Round Rock, 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
  • Landesklinikum Mistelbach /ID# 275764 — Mistelbach, Lower Austria, Austria
  • 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
  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 264498 — Salzburg, 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
  • Klinicki Bolnicki Centar Zagreb /ID# 276047 — Grad Zagreb, City of Zagreb, Croatia
  • Klinicka Bolnica Sveti Duh /ID# 275871 — Zagreb, City of Zagreb, Croatia
  • Specijalna bolnica Svjetlost /ID# 276051 — Zagreb, City of Zagreb, Croatia
  • Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha /ID# 264663 — Prague, Praha 6, Czechia
  • Fakultni nemocnice Kralovske Vinohrady /ID# 264660 — Prague, Czechia
  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 265073 — Nice, Alpes-Maritimes, France
  • Hopital Edouard Herriot /ID# 265072 — Lyon, Auvergne-Rhône-Alpes, France
  • Retine Gallien /ID# 265119 — Bordeaux, Gironde, France
  • Chu Bordeaux - Hopital Pellegrin /ID# 265123 — Bordeaux, New Aquitaine, France
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265077 — Nantes, Pays de la Loire Region, France
  • Clinique du Val d'Ouest /ID# 265121 — Écully, Rhone, France
  • Centre Hospitalier Intercommunal de Creteil /ID# 265080 — Créteil, Val-de-Marne, France
  • Centre Monticelli Paradis d'Ophtalmologie /ID# 265120 — Marseille, France
  • Clinique Jules Verne /ID# 265076 — Nantes, France
  • Hopital 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
  • Universitaetsklinikum Ulm /ID# 280004 — Ulm, 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
  • General Hospital of Athens G. Gennimatas /ID# 264243 — Athens, Attica, Greece
  • University General Hospital Attikon /ID# 264914 — Chaïdári, Attica, Greece
  • University General Hospital of Heraklion /ID# 264241 — Heraklion, Crete, 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
  • The Lady Davis Carmel Medical Center /ID# 265618 — Haifa, 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, The Marches, Italy
  • AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 265732 — Reggio Emilia, Italy
  • Unidade Local de Saude de Coimbra /ID# 264657 — Coimbra, Portugal
  • Unidade Local de Saude de Sao Jose, EPE /ID# 264655 — Lisbon, Portugal
  • Unidade Local de Saude de Santo Antonio /ID# 264658 — Porto, Portugal
  • Emanuelli Research & Development Center /ID# 264350 — Arecibo, Puerto Rico
  • Hospital Arruzafa /ID# 280175 — Córdoba, Cordoba, Spain
  • Hospital Universitario De Donostia /ID# 263155 — Donostia / San Sebastian, Guipuzcoa, Spain
  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179 — Majadahonda, Madrid, Spain
  • Instituto Oftalmologico Fernandez-Vega /ID# 263157 — Asturias, Principality of Asturias, Spain
  • Hospital Universitario Virgen Macarena /ID# 263180 — Seville, Sevilla, 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 Universitari i Politecnic La Fe /ID# 263441 — Valencia, 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
  • Bristol Eye Hospital /ID# 266155 — Bristol, United Kingdom
  • Royal Liverpool University Hospital /ID# 265854 — Liverpool, United Kingdom
  • The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 267024 — Newcastle upon Tyne, United Kingdom
  • Sunderland Royal Hospital /ID# 266664 — Sunderland, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record