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One-Shot gene therapy could slash eye injections for wet AMD

NCT ID NCT07007065

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 15 times

Summary

This study tests a gene therapy called ABBV-RGX-314 for people with wet age-related macular degeneration (AMD), a leading cause of vision loss. The goal is to see if a single treatment can reduce the need for frequent eye injections while keeping vision stable. About 561 adults aged 50 and older will take part, receiving either the gene therapy or standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 561 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Mar 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neovascular age-related macular degeneration

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    133 sites in 17 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Reggio Emilia, 42122, Italy

  • Advanced Research, LLC /ID# 276526

    RECRUITING

    Deerfield Beach, Florida, 33064-1346, United States

  • Advanced Vision Surgery Center /ID# 264208

    RECRUITING

    Longmont, Colorado, 80503, United States

  • American Vision Partners /ID# 264615

    RECRUITING

    Sun City, Arizona, 85351, United States

  • Associated Retinal Consultants /ID# 263289

    RECRUITING

    Royal Oak, Michigan, 48073, United States

  • Austin Clinical Research, LLC /ID# 263229

    RECRUITING

    Austin, Texas, 78750-2298, United States

  • Austin Retina Associates - Austin /ID# 266770

    RECRUITING

    Austin, Texas, 78705, United States

  • Austin Retina Associates - Round Rock /ID# 266776

    RECRUITING

    Round Rock, Texas, 78681, United States

  • Azienda Ospedaliero Universitaria Careggi /ID# 265739

    RECRUITING

    Florence, Firenze, 50134, Italy

  • Azienda Ospedaliero Universitaria delle Marche /ID# 265305

    RECRUITING

    Ancona, 60126, Italy

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

    RECRUITING

    Cona, Ferrara, 44124, Italy

  • Barnet Dulaney Perkins Eye Centers /ID# 279265

    RECRUITING

    Mesa, Arizona, 85206, United States

  • Bristol Eye Hospital /ID# 266155

    RECRUITING

    Bristol, BS1 2LX, United Kingdom

  • Budapest Retina Associates /ID# 265208

    RECRUITING

    Budapest, 1133, Hungary

  • Center for Retina and Macular Disease /ID# 264201

    RECRUITING

    Winter Haven, Florida, 33880, United States

  • Centre Hospitalier Intercommunal de Creteil /ID# 265080

    RECRUITING

    Créteil, Val-de-Marne, 94010, France

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

    RECRUITING

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

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

    RECRUITING

    Nantes, Pays de la Loire Region, 44000, France

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

    RECRUITING

    Nice, Alpes-Maritimes, 06001, France

  • Centre Monticelli Paradis d'Ophtalmologie /ID# 265120

    RECRUITING

    Marseille, 13008, France

  • Centre d'Oftalmologia Barraquer /ID# 266631

    RECRUITING

    Barcelona, 08021, Spain

  • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 266366

    RECRUITING

    Berlin, 12203, Germany

  • Charleston Neuroscience Institute - Bluffton /ID# 264037

    RECRUITING

    Bluffton, South Carolina, 29910, United States

  • Charleston Neuroscience Institute - Charleston /ID# 276425

    RECRUITING

    Charleston, South Carolina, 29414, United States

  • Chu Bordeaux - Hopital Pellegrin /ID# 265123

    RECRUITING

    Bordeaux, New Aquitaine, 33076, France

  • Cleveland Clinic - Cleveland /ID# 264210

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinique Jules Verne /ID# 265076

    RECRUITING

    Nantes, 44314, France

  • Clinique du Val d'Ouest /ID# 265121

    RECRUITING

    Écully, Rhone, 69130, France

  • Colorado Retina Associates /ID# 263247

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Debreceni Egyetem-Klinikai Kozpont /ID# 265453

    RECRUITING

    Debrecen, Hajdú-Bihar, 4032, Hungary

  • Edith Wolfson Medical Center /ID# 266304

    RECRUITING

    Holon, Central District, 5822012, Israel

  • Emanuelli Research & Development Center /ID# 264350

    RECRUITING

    Arecibo, 00612, Puerto Rico

  • Erie Retina Research /ID# 263287

    RECRUITING

    Erie, Pennsylvania, 16507, United States

  • Eye Research Foundation /ID# 277345

    RECRUITING

    Newport Beach, California, 92663, United States

  • Fakultni nemocnice Kralovske Vinohrady /ID# 264660

    RECRUITING

    Prague, 100 34, Czechia

  • Florida Retina Institute - Lake Mary /ID# 263288

    RECRUITING

    Lake Mary, Florida, 32746, United States

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

    RECRUITING

    Rome, Roma, 00168, Italy

  • Ganglion Orvosi Kozpont /ID# 265210

    RECRUITING

    Pécs, Baranya, 7621, Hungary

  • General Hospital of Athens G. Gennimatas /ID# 264243

    RECRUITING

    Athens, Attica, 11527, Greece

  • Gloucestershire Royal Hospital /ID# 276072

    RECRUITING

    Gloucester, Gloucestershire, GL1 3NN, United Kingdom

  • Hadassah Medical Center-Hebrew University /ID# 264300

    RECRUITING

    Jerusalem, 91120, Israel

  • Hopital Edouard Herriot /ID# 265072

    RECRUITING

    Lyon, Auvergne-Rhône-Alpes, 69003, France

  • Hopital Fondation Adolphe de Rothschild /ID# 265081

    RECRUITING

    Paris, 75019, France

  • Hospital Arruzafa /ID# 280175

    RECRUITING

    Córdoba, Cordoba, 14012, Spain

  • Hospital Clinico Universitario Lozano Blesa /ID# 263158

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Universitari Vall d Hebron /ID# 263301

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe /ID# 263441

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre /ID# 263544

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario De Donostia /ID# 263155

    RECRUITING

    Donostia / San Sebastian, Guipuzcoa, 20014, Spain

  • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179

    RECRUITING

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Virgen Macarena /ID# 263180

    RECRUITING

    Seville, Sevilla, 41009, Spain

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

    RECRUITING

    Barcelona, 08028, Spain

  • Instituto Oftalmologico Fernandez-Vega /ID# 263157

    RECRUITING

    Asturias, Principality of Asturias, 33012, Spain

  • Kaiser Permanente - Riverside Medical Center /ID# 263253

    RECRUITING

    Riverside, California, 92505, United States

  • Kaplan Medical Center /ID# 264399

    RECRUITING

    Rehovot, Central District, 7660101, Israel

  • Kepler Universitaetsklinikum GmbH /ID# 264493

    RECRUITING

    Linz, Upper Austria, 4020, Austria

  • Klinicka Bolnica Sveti Duh /ID# 275871

    RECRUITING

    Zagreb, City of Zagreb, 10000, Croatia

  • Klinicki Bolnicki Centar Zagreb /ID# 276047

    RECRUITING

    Grad Zagreb, City of Zagreb, 10000, Croatia

  • Klinikum Ludwigshafen /ID# 275448

    RECRUITING

    Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany

  • LMU Klinikum - Campus Innenstadt /ID# 264285

    RECRUITING

    Munich, Bavaria, 80336, Germany

  • Landesklinikum Mistelbach /ID# 275764

    RECRUITING

    Mistelbach, Lower Austria, 2130, Austria

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 264498

    RECRUITING

    Salzburg, 5020, Austria

  • Liverpool University Hospitals NHS Foundation Trust /ID# 265854

    RECRUITING

    Liverpool, Merseyside, L9 7AL, United Kingdom

  • Maine Eye Center - Marginal Way Campus /ID# 263251

    RECRUITING

    Portland, Maine, 04101, United States

  • Mayo Clinic - Minnesota /ID# 263977

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical Center -Vereya /ID# 275728

    RECRUITING

    Stara Zagora, 6000, Bulgaria

  • Medizinische Hochschule Hannover /ID# 264281

    RECRUITING

    Hanover, Lower Saxony, 30625, Germany

  • Medizinische Universitaet Graz /ID# 264511

    RECRUITING

    Graz, Styria, 8010, Austria

  • Medizinische Universitaet Innsbruck /ID# 264502

    RECRUITING

    Innsbruck, Tyrol, 6020, Austria

  • Mid Atlantic Retina - Philadelphia /ID# 263291

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Midwest Eye Institute North Indianapolis /ID# 264031

    RECRUITING

    Carmel, Indiana, 46290, United States

  • Midwest Retina /ID# 263231

    RECRUITING

    Dublin, Ohio, 43016, United States

  • Monmouth Retina Consultants /ID# 279252

    RECRUITING

    Little Silver, New Jersey, 07739, United States

  • Moorfields Eye Hospital /ID# 267227

    RECRUITING

    London, Greater London, EC1V 2PD, United Kingdom

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

    RECRUITING

    Mountain View, California, 94040-4119, United States

  • OCIPSMAED St. Luka /ID# 275727

    RECRUITING

    Plovdiv, 4002, Bulgaria

  • Ohio State Havener Eye Institute - Columbus /ID# 263987

    RECRUITING

    Columbus, Ohio, 43212, United States

  • Orange County Retina Medical Group /ID# 266612

    RECRUITING

    Santa Ana, California, 92705, United States

  • Rabin Medical Center /ID# 266449

    RECRUITING

    Petah Tikva, Central District, 4941492, Israel

  • Retina Associates of Southern California /ID# 263056

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Retina Centre of Ottawa /ID# 263803

    RECRUITING

    Ottawa, Ontario, K2B 7E9, Canada

  • Retina Consultants Of Southern California - Redlands /ID# 276496

    RECRUITING

    Redlands, California, 92374, United States

  • Retina Consultants of America /ID# 264038

    RECRUITING

    Mt. Pleasant, South Carolina, 29464, United States

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

    RECRUITING

    Edina, Minnesota, 55435, United States

  • Retina Consultants of San Diego /ID# 264026

    RECRUITING

    Poway, California, 92064-2530, United States

  • Retina Consultants of South Carolina - Ladson /ID# 277596

    RECRUITING

    Ladson, South Carolina, 29456, United States

  • Retina Consultants of Southern Colorado /ID# 263284

    RECRUITING

    Colorado Springs, Colorado, 80909, United States

  • Retina Consultants of Texas - Westover /ID# 264209

    RECRUITING

    San Antonio, Texas, 78251, United States

  • Retina Consultants of Texas /ID# 263274

    RECRUITING

    Houston, Texas, 77056-3030, United States

  • Retina Institute - St. Louis /ID# 263985

    RECRUITING

    St Louis, Missouri, 63128, United States

  • Retina Research Institute of Texas /ID# 263233

    RECRUITING

    Abilene, Texas, 79606, United States

  • Retina Specialist /ID# 264633

    RECRUITING

    Towson, Maryland, 21204, United States

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

    RECRUITING

    Fort Myers, Florida, 33917, United States

  • Retinal Consultants - Sacramento - Greenback Lane /ID# 263983

    RECRUITING

    Sacramento, California, 95841, United States

  • Retinal Diagnostic Center /ID# 263054

    RECRUITING

    Campbell, California, 95008, United States

  • Retine Gallien /ID# 265119

    RECRUITING

    Bordeaux, Gironde, 33000, France

  • Rocky Mountain Retina Consultants /ID# 263266

    RECRUITING

    Murray, Utah, 84107, United States

  • Segal Drug Trials, Inc /ID# 276966

    RECRUITING

    Delray Beach, Florida, 33484, United States

  • Shiley Eye Institute At Uc San Diego Health /ID# 276682

    RECRUITING

    La Jolla, California, 92093, United States

  • Sierra Eye Associates /ID# 263240

    RECRUITING

    Reno, Nevada, 89502, United States

  • Southeast Retina Center /ID# 263264

    RECRUITING

    Augusta, Georgia, 30909, United States

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

    RECRUITING

    Burgas, 8005, Bulgaria

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

    RECRUITING

    Sofia, 1784, Bulgaria

  • Specijalna bolnica Svjetlost /ID# 276051

    RECRUITING

    Zagreb, City of Zagreb, 10000, Croatia

  • Springfield Clinic Main Campus /ID# 265202

    RECRUITING

    Springfield, Illinois, 62703-2403, United States

  • Star Retina /ID# 266386

    RECRUITING

    Burleson, Texas, 76028, United States

  • Sunderland Royal Hospital /ID# 266664

    RECRUITING

    Sunderland, SR4 7TN, United Kingdom

  • Tel Aviv Sourasky Medical Center /ID# 266246

    RECRUITING

    Tel Aviv, Tel Aviv, 6423906, Israel

  • The Chaim Sheba Medical Center /ID# 264700

    RECRUITING

    Ramat Gan, Tel Aviv, 5265601, Israel

  • The Lady Davis Carmel Medical Center /ID# 265618

    RECRUITING

    Haifa, 34362, Israel

  • The Retina Care Center /ID# 263263

    RECRUITING

    Baltimore, Maryland, 21209, United States

  • The Retina Clinic London /ID# 266156

    RECRUITING

    London, Greater London, W1G 7LB, United Kingdom

  • The Retina Partners /ID# 263265

    RECRUITING

    Encino, California, 91436, United States

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

    RECRUITING

    San Francisco, California, 94143-2510, United States

  • UZ Gent /ID# 261300

    RECRUITING

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Unidade Local de Saude de Coimbra /ID# 264657

    RECRUITING

    Coimbra, 3000-075, Portugal

  • Unidade Local de Saude de Santo Antonio /ID# 264658

    RECRUITING

    Porto, 4099-003, Portugal

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

    RECRUITING

    Lisbon, 1150-199, Portugal

  • Universitaetsklinikum Bonn /ID# 264279

    RECRUITING

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitaetsklinikum Freiburg /ID# 275449

    RECRUITING

    Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

  • Universitaetsklinikum Hamburg-Eppendorf /ID# 264280

    RECRUITING

    Hamburg, 20246, Germany

  • Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284

    RECRUITING

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitaetsklinikum Tuebingen /ID# 264283

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsklinikum Ulm /ID# 280004

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

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

    RECRUITING

    Göttingen, Lower Saxony, 37075, Germany

  • Universitair Ziekenhuis Leuven /ID# 261302

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

  • University General Hospital Attikon /ID# 264914

    RECRUITING

    Chaïdári, Attica, 12462, Greece

  • University General Hospital of Heraklion /ID# 264241

    RECRUITING

    Heraklion, Crete, 71500, Greece

  • University General Hospital of Larissa /ID# 264247

    RECRUITING

    Larissa, 41110, Greece

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

    RECRUITING

    Prague, Praha 6, 169 02, Czechia

  • Vision Medical Research /ID# 277102

    RECRUITING

    Oak Lawn, Illinois, 60453, United States

  • Wolfe Eye Clinic - West Des Moines /ID# 263270

    RECRUITING

    West Des Moines, Iowa, 50266, United States

  • Yitzhak Shamir Medical Center /ID# 275679

    RECRUITING

    Ẕerifin, Central District, 70300, Israel

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