Neovascular Age-related Macular DegenerationPhase 3NCT07007065
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 Phase 3 study testing Surabgene Lomparvovec (ABBV-RGX-314) in people with Neovascular Age-related Macular Degeneration, run by AbbVie at 137 sites in 17 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Surabgene Lomparvovec (ABBV-RGX-314)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 137 sitesin 17 countries
- Study dates
- 5 Nov 2025to Mar 2033
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
137 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
137 sites in 17 countries
United States55 sites, 55 recruiting
- Recruiting
Retina Research Institute of Texas /ID# 263233
Abilene, Texas, 79606
- Recruiting
Southeast Retina Center /ID# 263264
Augusta, Georgia, 30909
- Recruiting
Austin Retina Associates - Austin /ID# 266770
Austin, Texas, 78705
- Recruiting
Austin Clinical Research, LLC /ID# 263229
Austin, Texas, 78750-2298
- Recruiting
The Retina Care Center /ID# 263263
Baltimore, Maryland, 21209
- Recruiting
Charleston Neuroscience Institute - Bluffton /ID# 264037
Bluffton, South Carolina, 29910
- Recruiting
Star Retina /ID# 266386
Burleson, Texas, 76028
- Recruiting
Retinal Diagnostic Center /ID# 263054
Campbell, California, 95008
- Recruiting
Midwest Eye Institute North Indianapolis /ID# 264031
Carmel, Indiana, 46290
- Recruiting
Charleston Neuroscience Institute - Charleston /ID# 276425
Charleston, South Carolina, 29414
- Recruiting
Cleveland Clinic - Cleveland /ID# 264210
Cleveland, Ohio, 44195
- Recruiting
Retina Consultants of Southern Colorado /ID# 263284
Colorado Springs, Colorado, 80909
- Recruiting
Ohio State Havener Eye Institute - Columbus /ID# 263987
Columbus, Ohio, 43212
- Recruiting
Advanced Research, LLC /ID# 276526
Deerfield Beach, Florida, 33064-1346
- Recruiting
Segal Drug Trials, Inc /ID# 276966
Delray Beach, Florida, 33484
- Recruiting
Midwest Retina /ID# 263231
Dublin, Ohio, 43016
- Recruiting
Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427
Edina, Minnesota, 55435
- Recruiting
The Retina Partners /ID# 263265
Encino, California, 91436
- Recruiting
Erie Retina Research /ID# 263287
Erie, Pennsylvania, 16507
- Recruiting
Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
Fort Myers, Florida, 33917
- Recruiting
Retina Consultants of Texas /ID# 263274
Houston, Texas, 77056-3030
- Recruiting
Retina Associates of Southern California /ID# 263056
Huntington Beach, California, 92647
- Recruiting
Shiley Eye Institute At Uc San Diego Health /ID# 276682
La Jolla, California, 92093
- Recruiting
Retina Consultants of South Carolina - Ladson /ID# 277596
Ladson, South Carolina, 29456
- Recruiting
Colorado Retina Associates /ID# 263247
Lakewood, Colorado, 80228
- Recruiting
Retina Associates - Lenexa /ID# 264607
Lenexa, Kansas, 66215
- Recruiting
Monmouth Retina Consultants /ID# 279252
Little Silver, New Jersey, 07739
- Recruiting
Advanced Vision Surgery Center /ID# 264208
Longmont, Colorado, 80503
- Recruiting
Barnet Dulaney Perkins Eye Center - Mesa /ID# 279265
Mesa, Arizona, 85206
- Recruiting
Northern California Retina Vitreous Associates - Mountain View /ID# 263990
Mountain View, California, 94040-4119
- Recruiting
Retina Consultants of America /ID# 264038
Mt. Pleasant, South Carolina, 29464
- Recruiting
Rocky Mountain Retina Consultants /ID# 263266
Murray, Utah, 84107
- Recruiting
Eye Research Foundation /ID# 277345
Newport Beach, California, 92663
- Recruiting
Vision Medical Research /ID# 277102
Oak Lawn, Illinois, 60453
- Recruiting
Florida Retina Institute - Orlando /ID# 263288
Orlando, Florida, 32806
- Recruiting
Mid Atlantic Retina - Philadelphia /ID# 263291
Philadelphia, Pennsylvania, 19107
- Recruiting
Maine Eye Center - Marginal Way Campus /ID# 263251
Portland, Maine, 04101
- Recruiting
Retina Consultants of San Diego /ID# 264026
Poway, California, 92064-2530
- Recruiting
Black Hills Regional Eye Institute /ID# 279258
Rapid City, South Dakota, 57701
- Recruiting
Retina Consultants Of Southern California - Redlands /ID# 276496
Redlands, California, 92374
- Recruiting
Sierra Eye Associates /ID# 263240
Reno, Nevada, 89502
- Recruiting
Kaiser Permanente - Riverside Medical Center /ID# 263253
Riverside, California, 92505
- Recruiting
Mayo Clinic - Minnesota /ID# 263977
Rochester, Minnesota, 55905
- Recruiting
Austin Retina Associates - Round Rock /ID# 266776
Round Rock, Texas, 78681
- Recruiting
Associated Retinal Consultants /ID# 263289
Royal Oak, Michigan, 48073
- Recruiting
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
Sacramento, California, 95841
- Recruiting
Retina Consultants of Texas - Westover /ID# 264209
San Antonio, Texas, 78251
- Recruiting
UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058
San Francisco, California, 94143-2510
- Recruiting
Orange County Retina Medical Group /ID# 266612
Santa Ana, California, 92705
- Recruiting
Springfield Clinic Main Campus /ID# 265202
Springfield, Illinois, 62703-2403
- Recruiting
Retina Institute - St. Louis /ID# 263985
St Louis, Missouri, 63128
- Recruiting
American Vision Partners /ID# 264615
Sun City, Arizona, 85351
- Recruiting
Retina Specialist /ID# 264633
Towson, Maryland, 21204
- Recruiting
Wolfe Eye Clinic - West Des Moines /ID# 263270
West Des Moines, Iowa, 50266
- Recruiting
Center for Retina and Macular Disease /ID# 264201
Winter Haven, Florida, 33880
Germany12 sites, 12 recruiting
- Recruiting
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 266366
Berlin, 12203
- Recruiting
Universitaetsklinikum Bonn /ID# 264279
Bonn, North Rhine-Westphalia, 53127
- Recruiting
Universitaetsklinikum Freiburg /ID# 275449
Freiburg im Breisgau, Baden-Wurttemberg, 79106
- Recruiting
Universitaetsmedizin Goettingen - Georg-August-Universitaet /ID# 264282
Göttingen, Lower Saxony, 37075
- Recruiting
Universitaetsklinikum Hamburg-Eppendorf /ID# 264280
Hamburg, 20246
- Recruiting
Medizinische Hochschule Hannover /ID# 264281
Hanover, Lower Saxony, 30625
- Recruiting
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284
Lübeck, Schleswig-Holstein, 23538
- Recruiting
Klinikum Ludwigshafen /ID# 275448
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063
- Recruiting
LMU Klinikum - Campus Innenstadt /ID# 264285
Munich, Bavaria, 80336
- Recruiting
Universitaetsklinikum Muenster /ID# 280155
Münster, North Rhine-Westphalia, 48149
- Recruiting
Universitaetsklinikum Tuebingen /ID# 264283
Tübingen, Baden-Wurttemberg, 72076
- Recruiting
Universitaetsklinikum Ulm /ID# 280004
Ulm, Baden-Wurttemberg, 89081
France11 sites, 11 recruiting
- Recruiting
Retine Gallien /ID# 265119
Bordeaux, Gironde, 33000
- Recruiting
Chu Bordeaux - Hopital Pellegrin /ID# 265123
Bordeaux, New Aquitaine, 33076
- Recruiting
Centre Hospitalier Intercommunal de Creteil /ID# 265080
Créteil, Val-de-Marne, 94010
- Recruiting
Clinique du Val d'Ouest /ID# 265121
Écully, Rhone, 69130
- Recruiting
Hopital Edouard Herriot /ID# 265072
Lyon, Auvergne-Rhône-Alpes, 69003
- Recruiting
Centre Monticelli Paradis d'Ophtalmologie /ID# 265120
Marseille, 13008
- Recruiting
Centre Hospitalier Universitaire de Nantes - L Hopital l hotel-Dieu /ID# 265077
Nantes, Pays de la Loire Region, 44000
- Recruiting
Clinique Jules Verne /ID# 265076
Nantes, 44314
- Recruiting
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 265073
Nice, Alpes-Maritimes, 06001
- Recruiting
Hopital Fondation Adolphe de Rothschild /ID# 265081
Paris, 75019
- Recruiting
Centre Hospitalier National d'Ophtalmologie Quinze-Vingts /ID# 265125
Paris, Île-de-France Region, 75571
Spain11 sites, 11 recruiting
- Recruiting
Instituto Oftalmologico Fernandez-Vega /ID# 263157
Asturias, Principality of Asturias, 33012
- Recruiting
Centre d'Oftalmologia Barraquer /ID# 266631
Barcelona, 08021
- Recruiting
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152
Barcelona, 08028
- Recruiting
Hospital Universitari Vall d Hebron /ID# 263301
Barcelona, 08035
- Recruiting
Hospital Arruzafa /ID# 280175
Córdoba, Cordoba, 14012
- Recruiting
Hospital Universitario De Donostia /ID# 263155
Donostia / San Sebastian, Guipuzcoa, 20014
- Recruiting
Hospital Universitario 12 de Octubre /ID# 263544
Madrid, 28041
- Recruiting
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179
Majadahonda, Madrid, 28222
- Recruiting
Hospital Universitario Virgen Macarena /ID# 263180
Seville, Sevilla, 41009
- Recruiting
Hospital Universitari i Politecnic La Fe /ID# 263441
Valencia, 46026
- Recruiting
Hospital Clinico Universitario Lozano Blesa /ID# 263158
Zaragoza, 50009
Israel8 sites, 8 recruiting
- Recruiting
The Lady Davis Carmel Medical Center /ID# 265618
Haifa, 34362
- Recruiting
Edith Wolfson Medical Center /ID# 266304
Holon, Central District, 5822012
- Recruiting
Hadassah Medical Center-Hebrew University /ID# 264300
Jerusalem, 91120
- Recruiting
Rabin Medical Center /ID# 266449
Petah Tikva, Central District, 4941492
- Recruiting
The Chaim Sheba Medical Center /ID# 264700
Ramat Gan, Tel Aviv, 5265601
- Recruiting
Kaplan Medical Center /ID# 264399
Rehovot, Central District, 7660101
- Recruiting
Tel Aviv Sourasky Medical Center /ID# 266246
Tel Aviv, Tel Aviv, 6423906
- Recruiting
Yitzhak Shamir Medical Center /ID# 275679
Ẕerifin, Central District, 70300
United Kingdom7 sites, 7 recruiting
- Recruiting
Bristol Eye Hospital /ID# 266155
Bristol, BS1 2LX
- Recruiting
Gloucestershire Royal Hospital /ID# 276072
Gloucester, Gloucestershire, GL1 3NN
- Recruiting
Royal Liverpool University Hospital /ID# 265854
Liverpool, L7 8XP
- Recruiting
Moorfields Eye Hospital /ID# 267227
London, Greater London, EC1V 2PD
- Recruiting
The Retina Clinic London /ID# 266156
London, Greater London, W1G 7LB
- Recruiting
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 267024
Newcastle upon Tyne, NE3 3HD
- Recruiting
Sunderland Royal Hospital /ID# 266664
Sunderland, SR4 7TN
Site Coordinator, 0191 5699039
Austria5 sites, 5 recruiting
- Recruiting
Medizinische Universitaet Graz /ID# 264511
Graz, Styria, 8010
- Recruiting
Medizinische Universitaet Innsbruck /ID# 264502
Innsbruck, Tyrol, 6020
- Recruiting
Kepler Universitaetsklinikum GmbH /ID# 264493
Linz, Upper Austria, 4020
- Recruiting
Landesklinikum Mistelbach /ID# 275764
Mistelbach, Lower Austria, 2130
- Recruiting
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 264498
Salzburg, 5020
Italy5 sites, 5 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche /ID# 265305
Ancona, The Marches, 60126
- Recruiting
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 276017
Cona, Ferrara, 44124
- Recruiting
Azienda Ospedaliero Universitaria Careggi /ID# 265739
Florence, Firenze, 50134
- Recruiting
AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 265732
Reggio Emilia, 42122
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 276032
Rome, Roma, 00168
Bulgaria4 sites, 4 recruiting
- Recruiting
Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729
Burgas, 8005
- Recruiting
OCIPSMAED St. Luka /ID# 275727
Plovdiv, 4002
- Recruiting
Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730
Sofia, 1784
- Recruiting
Medical Center -Vereya /ID# 275728
Stara Zagora, 6000
Greece4 sites, 4 recruiting
- Recruiting
General Hospital of Athens G. Gennimatas /ID# 264243
Athens, Attica, 11527
- Recruiting
University General Hospital Attikon /ID# 264914
Chaïdári, Attica, 12462
Site Coordinator, +30210 5831336
- Recruiting
University General Hospital of Heraklion /ID# 264241
Heraklion, Crete, 71500
- Recruiting
University General Hospital of Larissa /ID# 264247
Larissa, 41110
Croatia3 sites, 3 recruiting
- Recruiting
Klinicki Bolnicki Centar Zagreb /ID# 276047
Grad Zagreb, City of Zagreb, 10000
- Recruiting
Klinicka Bolnica Sveti Duh /ID# 275871
Zagreb, City of Zagreb, 10000
- Recruiting
Specijalna bolnica Svjetlost /ID# 276051
Zagreb, City of Zagreb, 10000
Hungary3 sites, 3 recruiting
- Recruiting
Budapest Retina Associates /ID# 265208
Budapest, 1133
- Recruiting
Debreceni Egyetem-Klinikai Kozpont /ID# 265453
Debrecen, Hajdú-Bihar, 4032
- Recruiting
Ganglion Orvosi Kozpont /ID# 265210
Pécs, Baranya, 7621
Portugal3 sites, 3 recruiting
- Recruiting
Unidade Local de Saude de Coimbra /ID# 264657
Coimbra, 3000-075
- Recruiting
Unidade Local de Saude de Sao Jose, EPE /ID# 264655
Lisbon, 1150-199
- Recruiting
Unidade Local de Saude de Santo Antonio /ID# 264658
Porto, 4099-003
Belgium2 sites, 2 recruiting
- Recruiting
UZ Gent /ID# 261300
Ghent, Oost-Vlaanderen, 9000
- Recruiting
Universitair Ziekenhuis Leuven /ID# 261302
Leuven, Vlaams-Brabant, 3000
Czechia2 sites, 2 recruiting
- Recruiting
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha /ID# 264663
Prague, Praha 6, 169 02
- Recruiting
Fakultni nemocnice Kralovske Vinohrady /ID# 264660
Prague, 100 34
Canada1 site, 1 recruiting
- Recruiting
Retina Centre of Ottawa /ID# 263803
Ottawa, Ontario, K2B 7E9
Puerto Rico1 site, 1 recruiting
- Recruiting
Emanuelli Research & Development Center /ID# 264350
Arecibo, 00612
About this study
Official title: 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.
Read more
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.
- Being tested
- Surabgene Lomparvovec (ABBV-RGX-314), Ranibizumab Control
- Keywords
- Neovascular age-related macular degeneration, Surabgene Lomparvovec, ABBV-RGX-314
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surabgene Lomparvovec (ABBV-RGX-314)Drug
Also called Surabgene Lomparvovec
subretinal injection
Ranibizumab ControlDrug
intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 | Experimental | Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time. Receives: 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. Receives: Drug: Surabgene Lomparvovec (ABBV-RGX-314) |
| Ranibizumab Control Group | Experimental | Ranibizumab administered via intravitreal injection as needed PRN Receives: Drug: Ranibizumab Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 5 years
Secondary outcomes (2)
Change from Baseline in best corrected visual acuity (BCVA)
BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart
Measured: 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.
Measured: Up to 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start5 Nov 2025
- Primary completionMar 2033 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 561 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007065
- Sponsor's protocol ID
- M24-528
- Other IDs
- 2024-512298-28-00
- Status last verified
- Oct 2026
- First submitted
- 28 May 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.