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)

NCT07007065 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: M24-5282024-512298-28-00
• Study Type: interventional
• Target: 561
• Locations: 17 countries
• Sites: 128

Brief 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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Neovascular age-related macular degeneration; Surabgene Lomparvovec; ABBV-RGX-314

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change from Baseline in best corrected visual acuity (BCVA)

  Up to 3 Years

• Annualized intravitreal anti-VEGF injection rate

  Up to 3 Years

Study Arms (3)

Surabgene Lomparvovec (ABBV-RGX-314) Dose 1

EXPERIMENTAL

Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time.

Drug: Surabgene Lomparvovec (ABBV-RGX-314)

Surabgene Lomparvovec (ABBV-RGX-314) Dose 2

EXPERIMENTAL

Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time.

Drug: Surabgene Lomparvovec (ABBV-RGX-314)

Ranibizumab Control Group

EXPERIMENTAL

Ranibizumab administered via intravitreal injection as needed PRN

Drug: Ranibizumab Control

Interventions

Surabgene Lomparvovec (ABBV-RGX-314) DRUG

subretinal injection

Also known as: Surabgene Lomparvovec

Surabgene Lomparvovec (ABBV-RGX-314) Dose 1; Surabgene Lomparvovec (ABBV-RGX-314) Dose 2

Ranibizumab Control DRUG

intravitreal injection

Ranibizumab Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (128)

Barnet Dulaney Perkins Eye Centers /ID# 279265

Mesa, Arizona, 85206, United States

RECRUITING

American Vision Partners /ID# 264615

Sun City, Arizona, 85351, United States

RECRUITING

Retinal Diagnostic Center /ID# 263054

Campbell, California, 95008, United States

RECRUITING

The Retina Partners /ID# 263265

Encino, California, 91436, United States

RECRUITING

Retina Associates of Southern California /ID# 263056

Huntington Beach, California, 92647, United States

RECRUITING

Northern California Retina Vitreous Associates - Mountain View /ID# 263990

Mountain View, California, 94040-4119, United States

RECRUITING

Retina Consultants of San Diego /ID# 264026

Poway, California, 92064-2530, United States

RECRUITING

Retina Consultants Of Southern California - Redlands /ID# 276496

Redlands, California, 92374, United States

RECRUITING

Kaiser Permanente - Riverside Medical Center /ID# 263253

Riverside, California, 92505, United States

RECRUITING

Retinal Consultants - Sacramento - Greenback Lane /ID# 263983

Sacramento, California, 95841, United States

RECRUITING

UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058

San Francisco, California, 94143-2510, United States

RECRUITING

Orange County Retina Medical Group /ID# 266612

Santa Ana, California, 92705, United States

RECRUITING

Retina Consultants of Southern Colorado /ID# 263284

Colorado Springs, Colorado, 80909, United States

RECRUITING

Colorado Retina Associates /ID# 263247

Lakewood, Colorado, 80228, United States

RECRUITING

Advanced Vision Surgery Center /ID# 264208

Longmont, Colorado, 80503, United States

RECRUITING

Advanced Research, LLC /ID# 276526

Deerfield Beach, Florida, 33064-1346, United States

RECRUITING

Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631

Fort Myers, Florida, 33917, United States

RECRUITING

Florida Eye Specialists /ID# 276612

Jacksonville, Florida, 32256, United States

NOT YET RECRUITING

Florida Retina Institute - Lake Mary /ID# 263288

Lake Mary, Florida, 32746, United States

RECRUITING

New Vision Eye Center /ID# 276971

Vero Beach, Florida, 32960, United States

NOT YET RECRUITING

Center for Retina and Macular Disease /ID# 264201

Winter Haven, Florida, 33880, United States

RECRUITING

Southeast Retina Center /ID# 263264

Augusta, Georgia, 30909, United States

RECRUITING

Georgia Retina - Marietta /ID# 266850

Marietta, Georgia, 30060, United States

NOT YET RECRUITING

Retina Consultants of Hawaii, Inc. /ID# 266359

‘Aiea, Hawaii, 96701, United States

NOT YET RECRUITING

Springfield Clinic Main Campus /ID# 265202

Springfield, Illinois, 62703-2403, United States

RECRUITING

Midwest Eye Institute North Indianapolis /ID# 264031

Carmel, Indiana, 46290, United States

RECRUITING

Wolfe Eye Clinic - West Des Moines /ID# 263270

West Des Moines, Iowa, 50266, United States

RECRUITING

Maine Eye Center - Marginal Way Campus /ID# 263251

Portland, Maine, 04101, United States

RECRUITING

The Retina Care Center /ID# 263263

Baltimore, Maryland, 21209, United States

RECRUITING

Retina Specialist /ID# 264633

Towson, Maryland, 21204, United States

RECRUITING

Associated Retinal Consultants /ID# 263289

Royal Oak, Michigan, 48073, United States

RECRUITING

Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427

Edina, Minnesota, 55435, United States

RECRUITING

Mayo Clinic - Minnesota /ID# 263977

Rochester, Minnesota, 55905, United States

RECRUITING

Retina Institute - St. Louis /ID# 263985

St Louis, Missouri, 63128, United States

RECRUITING

Monmouth Retina Consultants /ID# 279252

Little Silver, New Jersey, 07739, United States

RECRUITING

Cleveland Clinic - Cleveland /ID# 264210

Cleveland, Ohio, 44195, United States

RECRUITING

Midwest Retina /ID# 263231

Dublin, Ohio, 43016, United States

RECRUITING

Erie Retina Research /ID# 263287

Erie, Pennsylvania, 16507, United States

RECRUITING

Charleston Neuroscience Institute - Bluffton /ID# 264037

Bluffton, South Carolina, 29910, United States

RECRUITING

Charleston Neuroscience Institute - Charleston /ID# 276425

Charleston, South Carolina, 29414, United States

RECRUITING

Retina Consultants of South Carolina - Ladson /ID# 277596

Ladson, South Carolina, 29456, United States

RECRUITING

Retina Consultants of America /ID# 264038

Mt. Pleasant, South Carolina, 29464, United States

RECRUITING

Palmetto Retina Center - West Columbia /ID# 263254

West Columbia, South Carolina, 29169, United States

NOT YET RECRUITING

Tennessee Retina /ID# 263238

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Retina Research Institute of Texas /ID# 263233

Abilene, Texas, 79606, United States

RECRUITING

Austin Retina Associates - Austin /ID# 266770

Austin, Texas, 78705, United States

RECRUITING

Austin Clinical Research, LLC /ID# 263229

Austin, Texas, 78750-2298, United States

RECRUITING

Star Retina /ID# 266386

Burleson, Texas, 76028, United States

RECRUITING

Retina Consultants of Texas /ID# 263274

Houston, Texas, 77056-3030, United States

RECRUITING

Austin Retina Associates - Round Rock /ID# 266776

Round Rock, Texas, 78681, United States

RECRUITING

Retina Consultants of Texas - Westover /ID# 264209

San Antonio, Texas, 78251, United States

RECRUITING

Rocky Mountain Retina Consultants /ID# 263266

Murray, Utah, 84107, United States

RECRUITING

Spokane Eye Clinic /ID# 276934

Spokane, Washington, 99204, United States

NOT YET RECRUITING

Medizinische Universitaet Graz /ID# 264511

Graz, Styria, 8010, Austria

RECRUITING

Medizinische Universitaet Innsbruck /ID# 264502

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Kepler Universitaetsklinikum GmbH /ID# 264493

Linz, Upper Austria, 4020, Austria

RECRUITING

UZ Gent /ID# 261300

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Universitair Ziekenhuis Leuven /ID# 261302

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729

Burgas, 8005, Bulgaria

RECRUITING

OCIPSMAED St. Luka /ID# 275727

Plovdiv, 4002, Bulgaria

RECRUITING

Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730

Sofia, 1784, Bulgaria

RECRUITING

Medical Center -Vereya /ID# 275728

Stara Zagora, 6000, Bulgaria

RECRUITING

Retina Centre of Ottawa /ID# 263803

Ottawa, Ontario, K2B 7E9, Canada

RECRUITING

Klinicki Bolnicki Centar Zagreb /ID# 276047

Grad Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Klinicka Bolnica Sveti Duh /ID# 275871

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Specijalna bolnica Svjetlost /ID# 276051

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha /ID# 264663

Prague, Praha 6, 169 02, Czechia

RECRUITING

Fakultni nemocnice Kralovske Vinohrady /ID# 264660

Prague, 100 34, Czechia

RECRUITING

Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 265073

Nice, Alpes-Maritimes, 06001, France

RECRUITING

Hopital Edouard Herriot /ID# 265072

Lyon, Auvergne-Rhône-Alpes, 69003, France

RECRUITING

CHU Bordeaux - Hopital Pellegrin /ID# 265123

Bordeaux, New Aquitaine, 33076, France

RECRUITING

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265077

Nantes, Pays de la Loire Region, 44000, France

RECRUITING

Centre Hospitalier Intercommunal de Creteil /ID# 265080

Créteil, Val-de-Marne, 94010, France

RECRUITING

Centre Monticelli Paradis d'Ophtalmologie /ID# 265120

Marseille, 13008, France

RECRUITING

Clinique Jules Verne /ID# 265076

Nantes, 44314, France

RECRUITING

Hôpital Fondation Adolphe de Rothschild /ID# 265081

Paris, 75019, France

RECRUITING

Centre Hospitalier National d'Ophtalmologie Quinze-Vingts /ID# 265125

Paris, Île-de-France Region, 75571, France

RECRUITING

Universitaetsklinikum Freiburg /ID# 275449

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

RECRUITING

Universitaetsklinikum Tuebingen /ID# 264283

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

LMU Klinikum - Campus Innenstadt /ID# 264285

Munich, Bavaria, 80336, Germany

RECRUITING

Universitaetsmedizin Goettingen - Georg-August-Universitaet /ID# 264282

Göttingen, Lower Saxony, 37075, Germany

RECRUITING

Medizinische Hochschule Hannover /ID# 264281

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Universitaetsklinikum Bonn /ID# 264279

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

Klinikum Ludwigshafen /ID# 275448

Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 266366

Berlin, 12203, Germany

RECRUITING

Universitaetsklinikum Hamburg-Eppendorf /ID# 264280

Hamburg, 20246, Germany

RECRUITING

General Hospital of Athens G. Gennimatas /ID# 264243

Athens, Attica, 11527, Greece

RECRUITING

University General Hospital Attikon /ID# 264914

Athens, Attica, 12462, Greece

RECRUITING

University General Hospital of Larissa /ID# 264247

Larissa, 41110, Greece

RECRUITING

Ganglion Orvosi Kozpont /ID# 265210

Pécs, Baranya, 7621, Hungary

RECRUITING

Debreceni Egyetem-Klinikai Kozpont /ID# 265453

Debrecen, Hajdú-Bihar, 4032, Hungary

RECRUITING

Budapest Retina Associates /ID# 265208

Budapest, 1133, Hungary

RECRUITING

Edith Wolfson Medical Center /ID# 266304

Holon, Central District, 5822012, Israel

RECRUITING

Rabin Medical Center /ID# 266449

Petah Tikva, Central District, 4941492, Israel

RECRUITING

Kaplan Medical Center /ID# 264399

Rehovot, Central District, 7660101, Israel

RECRUITING

Yitzhak Shamir Medical Center /ID# 275679

Ẕerifin, Central District, 70300, Israel

RECRUITING

The Chaim Sheba Medical Center /ID# 264700

Ramat Gan, Tel Aviv, 5265601, Israel

RECRUITING

Tel Aviv Sourasky Medical Center /ID# 266246

Tel Aviv, Tel Aviv, 6423906, Israel

RECRUITING

The Lady Davis Carmel Medical Center /ID# 265618

Haifa, 34362, Israel

RECRUITING

Hadassah Medical Center-Hebrew University /ID# 264300

Jerusalem, 91120, Israel

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 276017

Cona, Ferrara, 44124, Italy

RECRUITING

Azienda Ospedaliero Universitaria Careggi /ID# 265739

Florence, Firenze, 50134, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 276032

Rome, Roma, 00168, Italy

RECRUITING

Azienda Ospedaliero Universitaria delle Marche /ID# 265305

Ancona, 60126, Italy

RECRUITING

AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 265732

Reggio Emilia, 42122, Italy

RECRUITING

Unidade Local de Saude de Coimbra /ID# 264657

Coimbra, 3000-075, Portugal

RECRUITING

Unidade Local de Saude de Sao Jose, EPE /ID# 264655

Lisbon, 1150-199, Portugal

RECRUITING

Unidade Local de Saude de Santo Antonio /ID# 264658

Porto, 4099-003, Portugal

RECRUITING

Emanuelli Research & Development Center /ID# 264350

Arecibo, 00612, Puerto Rico

RECRUITING

Hospital Arruzafa /ID# 280175

Córdoba, Cordoba, 14012, Spain

RECRUITING

Hospital Universitario De Donostia /ID# 263155

Donostia / San Sebastian, Guipuzcoa, 20014, Spain

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179

Majadahonda, Madrid, 28222, Spain

RECRUITING

Instituto Oftalmológico Fernández-Vega /ID# 263157

Asturias, Principality of Asturias, 33012, Spain

RECRUITING

Hospital Universitario Virgen Macarena /ID# 263180

Seville, Sevilla, 41009, Spain

RECRUITING

Centre d'Oftalmologia Barraquer /ID# 266631

Barcelona, 08021, Spain

RECRUITING

Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152

Barcelona, 08028, Spain

RECRUITING

Hospital Universitari Vall d'Hebron /ID# 263301

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario 12 de Octubre /ID# 263544

Madrid, 28041, Spain

RECRUITING

Hospital Universitari i Politecnic La Fe /ID# 263441

Valencia, 46026, Spain

RECRUITING

Hospital Clinico Universitario Lozano Blesa /ID# 263158

Zaragoza, 50009, Spain

RECRUITING

Gloucestershire Royal Hospital /ID# 276072

Gloucester, Gloucestershire, GL1 3NN, United Kingdom

RECRUITING

Moorfields Eye Hospital /ID# 267227

London, Greater London, EC1V 2PD, United Kingdom

RECRUITING

The Retina Clinic London /ID# 266156

London, Greater London, W1G 7LB, United Kingdom

RECRUITING

Liverpool University Hospitals NHS Foundation Trust /ID# 265854

Liverpool, Merseyside, L9 7AL, United Kingdom

RECRUITING

Bristol Eye Hospital /ID# 266155

Bristol, BS1 2LX, United Kingdom

RECRUITING

Manchester Royal Eye Hospital /ID# 266153

Manchester, M13 9WL, United Kingdom

NOT YET RECRUITING

Sunderland Royal Hospital /ID# 266664

Sunderland, SR4 7TN, United Kingdom

RECRUITING

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: June 5, 2025
• Study Start: November 5, 2025
• Primary Completion (Estimated): March 1, 2033
• Study Completion (Estimated): March 1, 2033
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

GB (7); IT (5); FR (9); AU (3); CZ (2); CA (1); DE (10); ES (11); BE (2); IL (8); PT (3); GR (3); PR (1); HU (3); CR (3); BU (4); US (53)