NCT07007065RecruitingPhase 3
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)
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)
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 561 (estimated)
- First submitted
- 28 May 2025
- Start date
- 5 Nov 2025
- Primary completion date
- 31 Mar 2033
- Lead sponsor
- AbbVie
- Diseases
- Macular degeneration
- NCT number
- NCT07007065
- EU CT number
- 2024-512298-28-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 561
- From 5 Nov 2025 to the primary completion date, 31 Mar 2033
- 145 sites in 18 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Age
- Study eye with nAMD diagnosed \> 4 years from Screening Visit 1
Other
- CNV or macular edema in the study eye that is secondary to any causes other than AMD
- 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.
- Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.
Who the study is looking for
- 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)
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (145)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Recruiting |
| Medizinische Universitaet Innsbruck Coordinator of this site? Confirm its status | Innsbruck | Austria | Recruiting |
| Johannes Kepler University Linz Coordinator of this site? Confirm its status | Linz | Austria | Recruiting |
| NOE Landesgesundheitsagentur Coordinator of this site? Confirm its status | Mistelbach | Austria | Recruiting |
| Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Recruiting |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Specialized Eye Hospital For Active Treatment Burgas OOD Coordinator of this site? Confirm its status | Burgas | Bulgaria | Recruiting |
| Assoc. Prof. Dr. Desislava Koleva Outpatient clinic for individual practice for specialized medical assistance in eye diseases "St. Luka" EOOD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| Specialized Hospital For Active Treatment Of Eye Diseases Zora OOD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Medical Center Vereya EOOD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Recruiting |
| Retina Centre of Ottawa /ID# 263803 Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Fakultni nemocnice Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| Ustredni Vojenska Nemocnice Vojenska Fakultni Nemocnice Praha Coordinator of this site? Confirm its status | Prague 6 | Czechia | Recruiting |
| Charite Universitaetsmedizin Berlin KöR Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
| Medical Center- University of Freiburg Coordinator of this site? Confirm its status | Freiburg im Breisgau | Germany | Recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf Coordinator of this site? Confirm its status | Hamburg | Germany | Recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| Klinikum der Stadt Ludwigshafen am Rhein gGmbH Coordinator of this site? Confirm its status | Ludwigshafen Am Rhein | Germany | Recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Recruiting |
| Universitaet Muenster Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| LMU Klinikum Muenchen AöR Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Instituto Clinic De Oftalmologia Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Centro De Oftalmologia Barraquer S.A. Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Metavision Arruzafa S.L. Coordinator of this site? Confirm its status | Cordoba | Spain | Recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Instituto Oftalmologico Fernandez-Vega S.L. Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clinico Universitario Lozano Blesa Coordinator of this site? Confirm its status | Zaragoza | Spain | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Selarl Retine Tourny Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Pole Vision Val d'Ouest Coordinator of this site? Confirm its status | Écully | France | Recruiting |
| Hospital Edouard Herriot Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Monticelli Paradis d'Ophtalmologie Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Clinique Juge Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Institut Ophtalmologique De l Ouest Jules Verne Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Fondation A. de Rothschild Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Centre Hospitalier National d'Ophtalmologie des Quize-Vingts Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Bristol Eye Hospital /ID# 266155 Coordinator of this site? Confirm its status | Bristol | United Kingdom | Recruiting |
| Gloucestershire Royal Hospital /ID# 276072 Coordinator of this site? Confirm its status | Gloucester | United Kingdom | Recruiting |
| Royal Liverpool University Hospital /ID# 265854 Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| Moorfields Eye Hospital /ID# 267227 Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Retina Clinic London /ID# 266156 Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 267024 Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Recruiting |
| Sunderland Royal Hospital /ID# 266664 Coordinator of this site? Confirm its status | Sunderland | United Kingdom | Recruiting |
| General Hospital of Athens "G. Gennimatas" Coordinator of this site? Confirm its status | Athens | Greece | Recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Recruiting |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Recruiting |
| Specijalna bolnica Svjetlost Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| University Hospital Sveti Duh Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| University Hospital Centre Zagreb Coordinator of this site? Confirm its status | Zagreb | Croatia | Recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Recruiting |
| Budapest Retina Associates Kft. Coordinator of this site? Confirm its status | Budapest XIII | Hungary | Recruiting |
| University of Debrecen Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Nozologen Kft. Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| The Lady Davis Carmel Medical Center /ID# 265618 Coordinator of this site? Confirm its status | Haifa | Israel | Recruiting |
| Edith Wolfson Medical Center /ID# 266304 Coordinator of this site? Confirm its status | Holon | Israel | Recruiting |
| Hadassah Medical Center-Hebrew University /ID# 264300 Coordinator of this site? Confirm its status | Jerusalem | Israel | Recruiting |
| Rabin Medical Center /ID# 266449 Coordinator of this site? Confirm its status | Petah Tikva | Israel | Recruiting |
| The Chaim Sheba Medical Center /ID# 264700 Coordinator of this site? Confirm its status | Ramat Gan | Israel | Recruiting |
| Kaplan Medical Center /ID# 264399 Coordinator of this site? Confirm its status | Rehovot | Israel | Recruiting |
| Tel Aviv Sourasky Medical Center /ID# 266246 Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
| Yitzhak Shamir Medical Center /ID# 275679 Coordinator of this site? Confirm its status | Tsrifin | Israel | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| University Hospital Of Ferrara Coordinator of this site? Confirm its status | Ferrara | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Recruiting |
| Emanuelli Research & Development Center /ID# 264350 Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Recruiting |
| Unidade Local de Saúde de Coimbra, E.P.E. Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
| Unidade Local De Saude De Sao Jose E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Recruiting |
| Unidade Local De Saude De Santo Antonio E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Recruiting |
| University Hospital Bratislava Coordinator of this site? Confirm its status | Bratislava | Slovakia | Not yet recruiting |
| Fakultna nemocnica Trencin Coordinator of this site? Confirm its status | Trenčín | Slovakia | Not yet recruiting |
| Fakultna nemocnica s poliklinikou Zilina Coordinator of this site? Confirm its status | Žilina | Slovakia | Not yet recruiting |
| Retina Research Institute of Texas /ID# 263233 Coordinator of this site? Confirm its status | Abilene | United States | Recruiting |
| Southeast Retina Center /ID# 263264 Coordinator of this site? Confirm its status | Augusta | United States | Recruiting |
| Austin Retina Associates - Austin /ID# 266770 Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| Austin Clinical Research, LLC /ID# 263229 Coordinator of this site? Confirm its status | Austin | United States | Recruiting |
| The Retina Care Center /ID# 263263 Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| Charleston Neuroscience Institute - Bluffton /ID# 264037 Coordinator of this site? Confirm its status | Bluffton | United States | Recruiting |
| Star Retina /ID# 266386 Coordinator of this site? Confirm its status | Burleson | United States | Recruiting |
| Retinal Diagnostic Center /ID# 263054 Coordinator of this site? Confirm its status | Campbell | United States | Recruiting |
| Retina Partners Midwest, P.C. /ID# 264031 Coordinator of this site? Confirm its status | Carmel | United States | Recruiting |
| Charleston Neuroscience Institute - Charleston /ID# 276425 Coordinator of this site? Confirm its status | Charleston | United States | Recruiting |
| Cleveland Clinic - Cleveland /ID# 264210 Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Retina Consultants of Southern Colorado /ID# 263284 Coordinator of this site? Confirm its status | Colorado Springs | United States | Recruiting |
| Ohio State Havener Eye Institute - Columbus /ID# 263987 Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| Advanced Research, LLC /ID# 276526 Coordinator of this site? Confirm its status | Deerfield Beach | United States | Recruiting |
| Segal Drug Trials, Inc /ID# 276966 Coordinator of this site? Confirm its status | Delray Beach | United States | Recruiting |
| Midwest Retina /ID# 263231 Coordinator of this site? Confirm its status | Dublin | United States | Recruiting |
| Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427 Coordinator of this site? Confirm its status | Edina | United States | Recruiting |
| The Retina Partners /ID# 263265 Coordinator of this site? Confirm its status | Encino | United States | Recruiting |
| Erie Retina Research /ID# 263287 Coordinator of this site? Confirm its status | Erie | United States | Recruiting |
| Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631 Coordinator of this site? Confirm its status | Fort Myers | United States | Recruiting |
| Retina Consultants of Texas /ID# 263274 Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
| Retina Associates of Southern California /ID# 263056 Coordinator of this site? Confirm its status | Huntington Beach | United States | Recruiting |
| Retina Consultants of South Carolina - Ladson /ID# 277596 Coordinator of this site? Confirm its status | Ladson | United States | Recruiting |
| Shiley Eye Institute At Uc San Diego Health /ID# 276682 Coordinator of this site? Confirm its status | La Jolla | United States | Recruiting |
| Colorado Retina Associates /ID# 263247 Coordinator of this site? Confirm its status | Lakewood | United States | Recruiting |
| Retina Associates - Lenexa /ID# 264607 Coordinator of this site? Confirm its status | Lenexa | United States | Recruiting |
| Monmouth Retina Consultants /ID# 279252 Coordinator of this site? Confirm its status | Little Silver | United States | Recruiting |
| Advanced Vision Surgery Center /ID# 264208 Coordinator of this site? Confirm its status | Longmont | United States | Recruiting |
| Barnet Dulaney Perkins Eye Center - Mesa /ID# 279265 Coordinator of this site? Confirm its status | Mesa | United States | Recruiting |
| Northern California Retina Vitreous Associates - Mountain View /ID# 263990 Coordinator of this site? Confirm its status | Mountain View | United States | Recruiting |
| Retina Consultants of America /ID# 264038 Coordinator of this site? Confirm its status | Mt. Pleasant | United States | Recruiting |
| Rocky Mountain Retina Consultants /ID# 263266 Coordinator of this site? Confirm its status | Murray | United States | Recruiting |
| Eye Research Foundation /ID# 277345 Coordinator of this site? Confirm its status | Newport Beach | United States | Recruiting |
| Vision Medical Research /ID# 277102 Coordinator of this site? Confirm its status | Oak Lawn | United States | Recruiting |
| Florida Retina Institute - Orlando /ID# 263288 Coordinator of this site? Confirm its status | Orlando | United States | Recruiting |
| Mid Atlantic Retina - Philadelphia /ID# 263291 Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Maine Eye Center - Marginal Way Campus /ID# 263251 Coordinator of this site? Confirm its status | Portland | United States | Recruiting |
| Retina Consultants of San Diego /ID# 264026 Coordinator of this site? Confirm its status | Poway | United States | Recruiting |
| Black Hills Regional Eye Institute /ID# 279258 Coordinator of this site? Confirm its status | Rapid City | United States | Recruiting |
| Retina Consultants Of Southern California - Redlands /ID# 276496 Coordinator of this site? Confirm its status | Redlands | United States | Recruiting |
| Sierra Eye Associates /ID# 263240 Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Kaiser Permanente - Riverside Medical Center /ID# 263253 Coordinator of this site? Confirm its status | Riverside | United States | Recruiting |
| Mayo Clinic - Minnesota /ID# 263977 Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Austin Retina Associates - Round Rock /ID# 266776 Coordinator of this site? Confirm its status | Round Rock | United States | Recruiting |
| Associated Retinal Consultants /ID# 263289 Coordinator of this site? Confirm its status | Royal Oak | United States | Recruiting |
| Retinal Consultants - Sacramento - Greenback Lane /ID# 263983 Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
| Retina Consultants of Texas - Westover /ID# 264209 Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
| UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058 Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| Orange County Retina Medical Group /ID# 266612 Coordinator of this site? Confirm its status | Santa Ana | United States | Recruiting |
| Springfield Clinic Main Campus /ID# 265202 Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| Retina Institute - St. Louis /ID# 263985 Coordinator of this site? Confirm its status | St Louis | United States | Recruiting |
| American Vision Partners /ID# 264615 Coordinator of this site? Confirm its status | Sun City | United States | Recruiting |
| Retina Specialist /ID# 264633 Coordinator of this site? Confirm its status | Towson | United States | Recruiting |
| Wolfe Eye Clinic - West Des Moines /ID# 263270 Coordinator of this site? Confirm its status | West Des Moines | United States | Recruiting |
| Center for Retina and Macular Disease /ID# 264201 Coordinator of this site? Confirm its status | Winter Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.