Actively Recruiting
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)
Led by AbbVie · Updated on 2026-05-13
561
Participants Needed
104
Research Sites
381 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 [Week -6]) in the study eye
- Diagnosis of choroidal neovascularization secondary to age-related macular degeneration in the study eye with lesion size less than 10-disc areas
- Received at least 2 intravitreal anti-vascular endothelial growth factor injections in the past 6 months in the study eye prior to Screening Visit 1 and have been responsive
You will not qualify if you...
- Choroidal neovascularization or macular edema in the study eye caused by conditions other than age-related macular degeneration
- Study eye with nAMD diagnosed more than 4 years before Screening Visit 1
- Retinal pigment epithelial detachment greater than 400 µm or pigment epithelial detachment greater than 350 µm within the central 1 mm subfield in the study eye at Screening Visit 1
- Subretinal hemorrhage in the study eye greater than 50% of the total lesion area or within the parafovea (3 mm center of the macula)
- Retinal pigment epithelial tear involving the central 1 mm subfield in the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 104 locations
1
Barnet Dulaney Perkins Eye Centers /ID# 279265
Mesa, Arizona, United States, 85206
Actively Recruiting
2
American Vision Partners /ID# 264615
Sun City, Arizona, United States, 85351
Actively Recruiting
3
Retinal Diagnostic Center /ID# 263054
Campbell, California, United States, 95008
Actively Recruiting
4
The Retina Partners /ID# 263265
Encino, California, United States, 91436
Actively Recruiting
5
Retina Associates of Southern California /ID# 263056
Huntington Beach, California, United States, 92647
Actively Recruiting
6
Retina Consultants of San Diego /ID# 264026
Poway, California, United States, 92064-2530
Actively Recruiting
7
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
Sacramento, California, United States, 95841
Actively Recruiting
8
Orange County Retina Medical Group /ID# 266612
Santa Ana, California, United States, 92705
Actively Recruiting
9
Retina Consultants of Southern Colorado /ID# 263284
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
10
Colorado Retina Associates /ID# 263247
Lakewood, Colorado, United States, 80228
Actively Recruiting
11
Advanced Vision Surgery Center /ID# 264208
Longmont, Colorado, United States, 80503
Actively Recruiting
12
Advanced Research, LLC /ID# 276526
Deerfield Beach, Florida, United States, 33064-1346
Actively Recruiting
13
Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
Fort Myers, Florida, United States, 33917
Actively Recruiting
14
Florida Retina Institute - Lake Mary /ID# 263288
Lake Mary, Florida, United States, 32746
Actively Recruiting
15
Center for Retina and Macular Disease /ID# 264201
Winter Haven, Florida, United States, 33880
Actively Recruiting
16
Southeast Retina Center /ID# 263264
Augusta, Georgia, United States, 30909
Actively Recruiting
17
Springfield Clinic Main Campus /ID# 265202
Springfield, Illinois, United States, 62703-2403
Actively Recruiting
18
Midwest Eye Institute North Indianapolis /ID# 264031
Carmel, Indiana, United States, 46290
Actively Recruiting
19
Wolfe Eye Clinic - West Des Moines /ID# 263270
West Des Moines, Iowa, United States, 50266
Actively Recruiting
20
The Retina Care Center /ID# 263263
Baltimore, Maryland, United States, 21209
Actively Recruiting
21
Retina Specialist /ID# 264633
Towson, Maryland, United States, 21204
Actively Recruiting
22
Associated Retinal Consultants /ID# 263289
Royal Oak, Michigan, United States, 48073
Actively Recruiting
23
Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427
Edina, Minnesota, United States, 55435
Actively Recruiting
24
Mayo Clinic - Minnesota /ID# 263977
Rochester, Minnesota, United States, 55905
Actively Recruiting
25
Retina Institute - St. Louis /ID# 263985
St Louis, Missouri, United States, 63128
Actively Recruiting
26
Monmouth Retina Consultants /ID# 279252
Little Silver, New Jersey, United States, 07739
Actively Recruiting
27
Cleveland Clinic - Cleveland /ID# 264210
Cleveland, Ohio, United States, 44195
Actively Recruiting
28
Midwest Retina /ID# 263231
Dublin, Ohio, United States, 43016
Actively Recruiting
29
Erie Retina Research /ID# 263287
Erie, Pennsylvania, United States, 16507
Actively Recruiting
30
Charleston Neuroscience Institute /ID# 264037
Bluffton, South Carolina, United States, 29910
Actively Recruiting
31
Charleston Neuroscience Institute /ID# 276425
Charleston, South Carolina, United States, 29414
Actively Recruiting
32
Retina Consultants of South Carolina - Ladson /ID# 277596
Ladson, South Carolina, United States, 29456
Actively Recruiting
33
Retina Consultants of America /ID# 264038
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
34
Austin Retina Associates - Austin /ID# 266770
Austin, Texas, United States, 78705
Actively Recruiting
35
Austin Clinical Research, LLC /ID# 263229
Austin, Texas, United States, 78750-2298
Actively Recruiting
36
Star Retina /ID# 266386
Burleson, Texas, United States, 76028
Actively Recruiting
37
Retina Consultants of Texas /ID# 263274
Houston, Texas, United States, 77056-3030
Actively Recruiting
38
Retina Consultants of Texas - Westover /ID# 264209
San Antonio, Texas, United States, 78251
Actively Recruiting
39
Rocky Mountain Retina Consultants /ID# 263266
Murray, Utah, United States, 84107
Actively Recruiting
40
Medizinische Universitaet Graz /ID# 264511
Graz, Styria, Austria, 8010
Actively Recruiting
41
Medizinische Universitaet Innsbruck /ID# 264502
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
42
Kepler Universitaetsklinikum GmbH /ID# 264493
Linz, Upper Austria, Austria, 4020
Actively Recruiting
43
UZ Gent /ID# 261300
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
44
Universitair Ziekenhuis Leuven /ID# 261302
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
45
Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729
Burgas, Bulgaria, 8005
Actively Recruiting
46
OCIPSMAED St. Luka /ID# 275727
Plovdiv, Bulgaria, 4002
Actively Recruiting
47
Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730
Sofia, Bulgaria, 1784
Actively Recruiting
48
Medical Center -Vereya /ID# 275728
Stara Zagora, Bulgaria, 6000
Actively Recruiting
49
Retina Centre of Ottawa /ID# 263803
Ottawa, Ontario, Canada, K2B 7E9
Actively Recruiting
50
Specijalna bolnica Svjetlost /ID# 276051
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
51
Fakultni nemocnice Kralovske Vinohrady /ID# 264660
Prague, Czechia, 100 34
Actively Recruiting
52
Hopital Edouard Herriot /ID# 265072
Lyon, Auvergne-Rhône-Alpes, France, 69003
Actively Recruiting
53
CHU Bordeaux - Hopital Pellegrin /ID# 265123
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
54
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265077
Nantes, Pays de la Loire Region, France, 44000
Actively Recruiting
55
Centre Hospitalier Intercommunal de Creteil /ID# 265080
Créteil, Val-de-Marne, France, 94010
Actively Recruiting
56
Clinique Jules Verne /ID# 265076
Nantes, France, 44314
Actively Recruiting
57
Hôpital Fondation Adolphe de Rothschild /ID# 265081
Paris, France, 75019
Actively Recruiting
58
Centre Hospitalier National d'Ophtalmologie Quinze-Vingts /ID# 265125
Paris, Île-de-France Region, France, 75571
Actively Recruiting
59
Universitaetsklinikum Freiburg /ID# 275449
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
60
Universitaetsklinikum Tuebingen /ID# 264283
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
61
LMU Klinikum - Campus Innenstadt /ID# 264285
Munich, Bavaria, Germany, 80336
Actively Recruiting
62
Universitaetsmedizin Goettingen - Georg-August-Universitaet /ID# 264282
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
63
Medizinische Hochschule Hannover /ID# 264281
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
64
Universitaetsklinikum Bonn /ID# 264279
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
65
Klinikum Ludwigshafen /ID# 275448
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67063
Actively Recruiting
66
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
67
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 266366
Berlin, Germany, 12203
Actively Recruiting
68
Universitaetsklinikum Hamburg-Eppendorf /ID# 264280
Hamburg, Germany, 20246
Actively Recruiting
69
University General Hospital Attikon /ID# 264914
Athens, Attica, Greece, 12462
Actively Recruiting
70
University General Hospital of Larissa /ID# 264247
Larissa, Greece, 41110
Actively Recruiting
71
Ganglion Orvosi Kozpont /ID# 265210
Pécs, Baranya, Hungary, 7621
Actively Recruiting
72
Debreceni Egyetem-Klinikai Kozpont /ID# 265453
Debrecen, Hajdú-Bihar, Hungary, 4032
Actively Recruiting
73
Budapest Retina Associates /ID# 265208
Budapest, Hungary, 1133
Actively Recruiting
74
Edith Wolfson Medical Center /ID# 266304
Holon, Central District, Israel, 5822012
Actively Recruiting
75
Rabin Medical Center /ID# 266449
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
76
Kaplan Medical Center /ID# 264399
Rehovot, Central District, Israel, 7660101
Actively Recruiting
77
Yitzhak Shamir Medical Center /ID# 275679
Ẕerifin, Central District, Israel, 70300
Actively Recruiting
78
The Chaim Sheba Medical Center /ID# 264700
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
79
Tel Aviv Sourasky Medical Center /ID# 266246
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
80
Hadassah Medical Center-Hebrew University /ID# 264300
Jerusalem, Israel, 91120
Actively Recruiting
81
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 276017
Cona, Ferrara, Italy, 44124
Actively Recruiting
82
Azienda Ospedaliero Universitaria Careggi /ID# 265739
Florence, Firenze, Italy, 50134
Actively Recruiting
83
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 276032
Rome, Roma, Italy, 00168
Actively Recruiting
84
Azienda Ospedaliero Universitaria delle Marche /ID# 265305
Ancona, Italy, 60020
Actively Recruiting
85
Unidade Local de Saude de Coimbra, EPE /ID# 264657
Coimbra, Portugal, 3000-075
Actively Recruiting
86
Unidade Local de Saude de Sao Jose, EPE /ID# 264655
Lisbon, Portugal, 1150-199
Actively Recruiting
87
Unidade Local de Saude de Santo Antonio, E.P.E. /ID# 264658
Porto, Portugal, 4099-003
Actively Recruiting
88
Emanuelli Research & Development Center /ID# 264350
Arecibo, Puerto Rico, 00612
Actively Recruiting
89
Hospital Arruzafa /ID# 280175
Córdoba, Cordoba, Spain, 14012
Actively Recruiting
90
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
91
Instituto Oftalmológico Fernández-Vega /ID# 263157
Asturias, Principality of Asturias, Spain, 33012
Actively Recruiting
92
Hospital Universitario Virgen Macarena /ID# 263180
Seville, Sevilla, Spain, 41009
Actively Recruiting
93
Centre d'Oftalmologia Barraquer /ID# 266631
Barcelona, Spain, 08021
Actively Recruiting
94
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152
Barcelona, Spain, 08028
Actively Recruiting
95
Hospital Universitari Vall d'Hebron /ID# 263301
Barcelona, Spain, 08035
Actively Recruiting
96
Hospital Universitario 12 de Octubre /ID# 263544
Madrid, Spain, 28041
Actively Recruiting
97
Hospital Universitari i Politècnic La Fe /ID# 263441
Valencia, Spain, 46026
Actively Recruiting
98
Hospital Clinico Universitario Lozano Blesa /ID# 263158
Zaragoza, Spain, 50009
Actively Recruiting
99
Gloucestershire Royal Hospital /ID# 276072
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
Actively Recruiting
100
Moorfields Eye Hospital /ID# 267227
London, Greater London, United Kingdom, EC1V 2PD
Actively Recruiting
101
The Retina Clinic London /ID# 266156
London, Greater London, United Kingdom, W1G 7LB
Actively Recruiting
102
Liverpool University Hospitals NHS Foundation Trust /ID# 265854
Liverpool, Merseyside, United Kingdom, L9 7AL
Actively Recruiting
103
Bristol Eye Hospital /ID# 266155
Bristol, United Kingdom, BS1 2LX
Actively Recruiting
104
Sunderland Royal Hospital /ID# 266664
Sunderland, United Kingdom, SR4 7TN
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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