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)

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.

Study Overview

• Status: Recruiting
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Surabgene Lomparvovec (ABBV-RGX-314); Drug: Ranibizumab Control

• Study Type: Interventional
• Enrollment (Estimated): 561
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8010
      • Recruiting
      • Medizinische Universitaet Graz /ID# 264511
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Recruiting
      • Medizinische Universitaet Innsbruck /ID# 264502
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Recruiting
      • Kepler Universitaetsklinikum GmbH /ID# 264493
• Belgium
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • UZ Gent /ID# 261300
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • Universitair Ziekenhuis Leuven /ID# 261302
• Bulgaria
  • Burgas, Bulgaria, 8005
    • Recruiting
    • Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729
  • Plovdiv, Bulgaria, 4002
    • Recruiting
    • OCIPSMAED St. Luka /ID# 275727
  • Sofia, Bulgaria, 1784
    • Recruiting
    • Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730
  • Stara Zagora, Bulgaria, 6000
    • Recruiting
    • Medical Center -Vereya /ID# 275728
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K2B 7E9
      • Recruiting
      • Retina Centre of Ottawa /ID# 263803
• Croatia
  • City of Zagreb
    • Grad Zagreb, City of Zagreb, Croatia, 10000
      • Recruiting
      • Klinicki Bolnicki Centar Zagreb /ID# 276047
    • Zagreb, City of Zagreb, Croatia, 10000
      • Recruiting
      • Specijalna bolnica Svjetlost /ID# 276051
    • Zagreb, City of Zagreb, Croatia, 10000
      • Recruiting
      • Klinicka Bolnica Sveti Duh /ID# 275871
• Czechia
  • Prague, Czechia, 100 34
    • Recruiting
    • Fakultni nemocnice Kralovske Vinohrady /ID# 264660
  • Praha 6
    • Prague, Praha 6, Czechia, 169 02
      • Recruiting
      • Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha /ID# 264663
• France
  • Marseille, France, 13008
    • Recruiting
    • Centre Monticelli Paradis d'Ophtalmologie /ID# 265120
  • Nantes, France, 44314
    • Recruiting
    • Clinique Jules Verne /ID# 265076
  • Paris, France, 75019
    • Recruiting
    • Hôpital Fondation Adolphe de Rothschild /ID# 265081
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06001
      • Recruiting
      • Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 265073
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69003
      • Recruiting
      • Hopital Edouard Herriot /ID# 265072
  • New Aquitaine
    • Bordeaux, New Aquitaine, France, 33076
      • Recruiting
      • CHU Bordeaux - Hopital Pellegrin /ID# 265123
  • Pays de la Loire Region
    • Nantes, Pays de la Loire Region, France, 44000
      • Recruiting
      • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265077
  • Val-de-Marne
    • Créteil, Val-de-Marne, France, 94010
      • Recruiting
      • Centre Hospitalier Intercommunal de Creteil /ID# 265080
  • Île-de-France Region
    • Paris, Île-de-France Region, France, 75571
      • Recruiting
      • Centre Hospitalier National d'Ophtalmologie Quinze-Vingts /ID# 265125
• Germany
  • Berlin, Germany, 12203
    • Recruiting
    • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 266366
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitaetsklinikum Hamburg-Eppendorf /ID# 264280
  • Baden-Wurttemberg
    • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
      • Recruiting
      • Universitaetsklinikum Freiburg /ID# 275449
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Recruiting
      • Universitaetsklinikum Tuebingen /ID# 264283
  • Bavaria
    • Munich, Bavaria, Germany, 80336
      • Recruiting
      • LMU Klinikum - Campus Innenstadt /ID# 264285
  • Lower Saxony
    • Göttingen, Lower Saxony, Germany, 37075
      • Recruiting
      • Universitaetsmedizin Goettingen - Georg-August-Universitaet /ID# 264282
    • Hanover, Lower Saxony, Germany, 30625
      • Recruiting
      • Medizinische Hochschule Hannover /ID# 264281
  • North Rhine-Westphalia
    • Bonn, North Rhine-Westphalia, Germany, 53127
      • Recruiting
      • Universitaetsklinikum Bonn /ID# 264279
  • Rhineland-Palatinate
    • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67063
      • Recruiting
      • Klinikum Ludwigshafen /ID# 275448
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284
• Greece
  • Larissa, Greece, 41110
    • Recruiting
    • University General Hospital of Larissa /ID# 264247
  • Attica
    • Athens, Attica, Greece, 12462
      • Recruiting
      • University General Hospital Attikon /ID# 264914
      • Contact: Site Coordinator; Phone Number: +30210 5831336
    • Athens, Attica, Greece, 11527
      • Recruiting
      • General Hospital of Athens G. Gennimatas /ID# 264243
• Hungary
  • Budapest, Hungary, 1133
    • Recruiting
    • Budapest Retina Associates /ID# 265208
  • Baranya
    • Pécs, Baranya, Hungary, 7621
      • Recruiting
      • Ganglion Orvosi Kozpont /ID# 265210
  • Hajdú-Bihar
    • Debrecen, Hajdú-Bihar, Hungary, 4032
      • Recruiting
      • Debreceni Egyetem-Klinikai Kozpont /ID# 265453
• Israel
  • Haifa, Israel, 34362
    • Recruiting
    • The Lady Davis Carmel Medical Center /ID# 265618
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Center-Hebrew University /ID# 264300
  • Central District
    • Holon, Central District, Israel, 5822012
      • Recruiting
      • Edith Wolfson Medical Center /ID# 266304
    • Petah Tikva, Central District, Israel, 4941492
      • Recruiting
      • Rabin Medical Center /ID# 266449
    • Rehovot, Central District, Israel, 7660101
      • Recruiting
      • Kaplan Medical Center /ID# 264399
    • Ẕerifin, Central District, Israel, 70300
      • Recruiting
      • Yitzhak Shamir Medical Center /ID# 275679
  • Tel Aviv
    • Ramat Gan, Tel Aviv, Israel, 5265601
      • Recruiting
      • The Chaim Sheba Medical Center /ID# 264700
    • Tel Aviv, Tel Aviv, Israel, 6423906
      • Recruiting
      • Tel Aviv Sourasky Medical Center /ID# 266246
• Italy
  • Ancona, Italy, 60126
    • Recruiting
    • Azienda Ospedaliero Universitaria delle Marche /ID# 265305
  • Reggio Emilia, Italy, 42122
    • Recruiting
    • AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 265732
  • Ferrara
    • Cona, Ferrara, Italy, 44124
      • Recruiting
      • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 276017
  • Firenze
    • Florence, Firenze, Italy, 50134
      • Recruiting
      • Azienda Ospedaliero Universitaria Careggi /ID# 265739
  • Roma
    • Rome, Roma, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 276032
• Portugal
  • Coimbra, Portugal, 3000-075
    • Recruiting
    • Unidade Local de Saude de Coimbra /ID# 264657
  • Lisbon, Portugal, 1150-199
    • Recruiting
    • Unidade Local de Saude de Sao Jose, EPE /ID# 264655
  • Porto, Portugal, 4099-003
    • Recruiting
    • Unidade Local de Saude de Santo Antonio /ID# 264658
• Puerto Rico
  • Arecibo, Puerto Rico, 00612
    • Recruiting
    • Emanuelli Research & Development Center /ID# 264350
• Spain
  • Barcelona, Spain, 08028
    • Recruiting
    • Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152
  • Barcelona, Spain, 08021
    • Recruiting
    • Centre d'Oftalmologia Barraquer /ID# 266631
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron /ID# 263301
  • Madrid, Spain, 28041
    • Recruiting
    • Hospital Universitario 12 de Octubre /ID# 263544
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari i Politecnic La Fe /ID# 263441
  • Zaragoza, Spain, 50009
    • Recruiting
    • Hospital Clinico Universitario Lozano Blesa /ID# 263158
  • Cordoba
    • Córdoba, Cordoba, Spain, 14012
      • Recruiting
      • Hospital Arruzafa /ID# 280175
  • Guipuzcoa
    • Donostia / San Sebastian, Guipuzcoa, Spain, 20014
      • Recruiting
      • Hospital Universitario De Donostia /ID# 263155
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Recruiting
      • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179
  • Principality of Asturias
    • Asturias, Principality of Asturias, Spain, 33012
      • Recruiting
      • Instituto Oftalmológico Fernández-Vega /ID# 263157
  • Sevilla
    • Seville, Sevilla, Spain, 41009
      • Recruiting
      • Hospital Universitario Virgen Macarena /ID# 263180
• United Kingdom
  • Bristol, United Kingdom, BS1 2LX
    • Recruiting
    • Bristol Eye Hospital /ID# 266155
  • Manchester, United Kingdom, M13 9WL
    • Not yet recruiting
    • Manchester Royal Eye Hospital /ID# 266153
  • Sunderland, United Kingdom, SR4 7TN
    • Recruiting
    • Sunderland Royal Hospital /ID# 266664
  • Gloucestershire
    • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
      • Recruiting
      • Gloucestershire Royal Hospital /ID# 276072
  • Greater London
    • London, Greater London, United Kingdom, W1G 7LB
      • Recruiting
      • The Retina Clinic London /ID# 266156
    • London, Greater London, United Kingdom, EC1V 2PD
      • Recruiting
      • Moorfields Eye Hospital /ID# 267227
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L9 7AL
      • Recruiting
      • Liverpool University Hospitals NHS Foundation Trust /ID# 265854
• United States
  • Arizona
    • Mesa, Arizona, United States, 85206
      • Recruiting
      • Barnet Dulaney Perkins Eye Centers /ID# 279265
    • Sun City, Arizona, United States, 85351
      • Recruiting
      • American Vision Partners /ID# 264615
  • California
    • Campbell, California, United States, 95008
      • Recruiting
      • Retinal Diagnostic Center /ID# 263054
    • Encino, California, United States, 91436
      • Recruiting
      • The Retina Partners /ID# 263265
    • Huntington Beach, California, United States, 92647
      • Recruiting
      • Retina Associates of Southern California /ID# 263056
    • Mountain View, California, United States, 94040-4119
      • Recruiting
      • Northern California Retina Vitreous Associates - Mountain View /ID# 263990
    • Poway, California, United States, 92064-2530
      • Recruiting
      • Retina Consultants of San Diego /ID# 264026
    • Redlands, California, United States, 92374
      • Recruiting
      • Retina Consultants Of Southern California - Redlands /ID# 276496
    • Riverside, California, United States, 92505
      • Recruiting
      • Kaiser Permanente - Riverside Medical Center /ID# 263253
    • Sacramento, California, United States, 95841
      • Recruiting
      • Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
    • San Francisco, California, United States, 94143-2510
      • Recruiting
      • UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058
    • Santa Ana, California, United States, 92705
      • Recruiting
      • Orange County Retina Medical Group /ID# 266612
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Recruiting
      • Retina Consultants of Southern Colorado /ID# 263284
    • Lakewood, Colorado, United States, 80228
      • Recruiting
      • Colorado Retina Associates /ID# 263247
    • Longmont, Colorado, United States, 80503
      • Recruiting
      • Advanced Vision Surgery Center /ID# 264208
  • Florida
    • Deerfield Beach, Florida, United States, 33064-1346
      • Recruiting
      • Advanced Research, LLC /ID# 276526
    • Fort Myers, Florida, United States, 33917
      • Recruiting
      • Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
    • Jacksonville, Florida, United States, 32256
      • Not yet recruiting
      • Florida Eye Specialists /ID# 276612
    • Lake Mary, Florida, United States, 32746
      • Recruiting
      • Florida Retina Institute - Lake Mary /ID# 263288
    • Vero Beach, Florida, United States, 32960
      • Not yet recruiting
      • New Vision Eye Center /ID# 276971
    • Winter Haven, Florida, United States, 33880
      • Recruiting
      • Center for Retina and Macular Disease /ID# 264201
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Recruiting
      • Southeast Retina Center /ID# 263264
    • Marietta, Georgia, United States, 30060
      • Not yet recruiting
      • Georgia Retina - Marietta /ID# 266850
  • Hawaii
    • ‘Aiea, Hawaii, United States, 96701
      • Not yet recruiting
      • Retina Consultants of Hawaii, Inc. /ID# 266359
  • Illinois
    • Springfield, Illinois, United States, 62703-2403
      • Recruiting
      • Springfield Clinic Main Campus /ID# 265202
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Recruiting
      • Midwest Eye Institute North Indianapolis /ID# 264031
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Recruiting
      • Wolfe Eye Clinic - West Des Moines /ID# 263270
  • Maine
    • Portland, Maine, United States, 04101
      • Recruiting
      • Maine Eye Center - Marginal Way Campus /ID# 263251
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Recruiting
      • The Retina Care Center /ID# 263263
    • Towson, Maryland, United States, 21204
      • Recruiting
      • Retina Specialist /ID# 264633
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • Associated Retinal Consultants /ID# 263289
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Recruiting
      • Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic - Minnesota /ID# 263977
  • Missouri
    • St Louis, Missouri, United States, 63128
      • Recruiting
      • Retina Institute - St. Louis /ID# 263985
  • New Jersey
    • Little Silver, New Jersey, United States, 07739
      • Recruiting
      • Monmouth Retina Consultants /ID# 279252
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic - Cleveland /ID# 264210
    • Dublin, Ohio, United States, 43016
      • Recruiting
      • Midwest Retina /ID# 263231
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • Recruiting
      • Erie Retina Research /ID# 263287
  • South Carolina
    • Bluffton, South Carolina, United States, 29910
      • Recruiting
      • Charleston Neuroscience Institute - Bluffton /ID# 264037
    • Charleston, South Carolina, United States, 29414
      • Recruiting
      • Charleston Neuroscience Institute - Charleston /ID# 276425
    • Ladson, South Carolina, United States, 29456
      • Recruiting
      • Retina Consultants of South Carolina - Ladson /ID# 277596
    • Mt. Pleasant, South Carolina, United States, 29464
      • Recruiting
      • Retina Consultants of America /ID# 264038
    • West Columbia, South Carolina, United States, 29169
      • Not yet recruiting
      • Palmetto Retina Center - West Columbia /ID# 263254
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Not yet recruiting
      • Tennessee Retina /ID# 263238
  • Texas
    • Abilene, Texas, United States, 79606
      • Recruiting
      • Retina Research Institute of Texas /ID# 263233
    • Austin, Texas, United States, 78750-2298
      • Recruiting
      • Austin Clinical Research, LLC /ID# 263229
    • Austin, Texas, United States, 78705
      • Recruiting
      • Austin Retina Associates - Austin /ID# 266770
    • Burleson, Texas, United States, 76028
      • Recruiting
      • Star Retina /ID# 266386
    • Houston, Texas, United States, 77056-3030
      • Recruiting
      • Retina Consultants of Texas /ID# 263274
    • Round Rock, Texas, United States, 78681
      • Recruiting
      • Austin Retina Associates - Round Rock /ID# 266776
    • San Antonio, Texas, United States, 78251
      • Recruiting
      • Retina Consultants of Texas - Westover /ID# 264209
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Rocky Mountain Retina Consultants /ID# 263266
  • Washington
    • Spokane, Washington, United States, 99204
      • Not yet recruiting
      • Spokane Eye Clinic /ID# 276934

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surabgene Lomparvovec (ABBV-RGX-314) Dose 1; Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time.	Drug: Surabgene Lomparvovec (ABBV-RGX-314); subretinal injection; Other Names: Surabgene Lomparvovec
Experimental: Surabgene Lomparvovec (ABBV-RGX-314) Dose 2; Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time.	Drug: Surabgene Lomparvovec (ABBV-RGX-314); subretinal injection; Other Names: Surabgene Lomparvovec
Experimental: Ranibizumab Control Group; Ranibizumab administered via intravitreal injection as needed PRN	Drug: Ranibizumab Control; intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized intravitreal anti-VEGF injection rate	To assess the injection burden and the necessity for supplemental anti-VEGF injections over the first year of the study period across the different treatment groups.	Up to Week 54
Number of Participants Experiencing Adverse Events	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in best corrected visual acuity (BCVA)	BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart	Up to 3 Years
Annualized intravitreal anti-VEGF injection rate	To evaluate the long-term injection burden and the necessity for supplemental anti-VEGF injections across the different treatment groups.	Up to 3 Years

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033

Study Registration Dates

• First Submitted: May 28, 2025
• First Submitted That Met QC Criteria: May 28, 2025
• First Posted (Actual): June 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Neovascular age-related macular degeneration; Surabgene Lomparvovec; ABBV-RGX-314
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Wet Macular Degeneration; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: M24-528; 2024-512298-28-00 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No