Actively Recruiting
A Randomized, Controlled, Partially Masked Study to Assess Safety, Efficacy, Injection Burden, and Visual Acuity Preservation of Surabgene Lomparvovec in Adults With Neovascular Age-Related Macular Degeneration
Led by AbbVie · Updated on 2026-05-27
561
Participants Needed
128
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Neovascular age-related macular degeneration (nAMD), or "wet" AMD, involves abnormal growth of new blood vessels in the retina, the light-sensitive tissue at the back of the eye. Researchers are evaluating the safety and effectiveness of Surabgene Lomparvovec (ABBV-RGX-314), an investigational gene therapy, for treating adults aged 50 and older with previously treated nAMD. The study aims to compare this gene therapy to the current standard treatment, Ranibizumab, to better understand long-term visual preservation and treatment burden. Participants will be randomly assigned to one of three groups: two groups will receive a single subretinal injection of Surabgene Lomparvovec at different doses, and the third group will receive Ranibizumab injections as needed via intravitreal delivery. The study includes an assessment period starting two weeks before randomization and lasting up to five years. During this time, the treatment effects and safety will be monitored closely. Participants will attend monthly visits at a hospital or clinic, where medical assessments, blood tests, and questionnaires will be conducted to monitor side effects and treatment impact. Researchers will measure injection frequency, adverse events, and changes in visual acuity over up to five years. This long-term follow-up helps assess the safety and potential benefits of the gene therapy compared to standard care.
CONDITIONS
Brief 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...
- Adults aged 50 years or older
- Diagnosis of choroidal neovascularization secondary to age-related macular degeneration in the study eye
- Pseudophakic in the study eye, at least 12 weeks after cataract surgery
- Received at least 2 intravitreal anti-VEGF injections in the study eye in the past 6 months
- Responsive to prior anti-VEGF treatment as determined by investigator
You will not qualify if you...
- Choroidal neovascularization or macular edema in the study eye caused by conditions other than age-related macular degeneration
- Neovascular age-related macular degeneration diagnosed more than 4 years ago in the study eye
- Retinal pigment epithelial detachment greater than 400 micrometers or pigment epithelial detachment greater than 350 micrometers within the central 1 mm of the study eye
- Subretinal hemorrhage covering more than 50% of the lesion area or within 3 mm center of the macula in the study eye
- Retinal pigment epithelial tear involving the central 1 mm of the study eye
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 54 weeks
Participants receive either a one-time subretinal injection of Surabgene Lomparvovec (Dose 1 or Dose 2) or intravitreal Ranibizumab injections as needed.
1 injection visit plus additional visits as needed for Ranibizumab injections
Duration - Up to 3 years
Participants are monitored for safety, adverse events, and changes in visual acuity after treatment.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 128 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
Northern California Retina Vitreous Associates - Mountain View /ID# 263990
Mountain View, California, United States, 94040-4119
Actively Recruiting
7
Retina Consultants of San Diego /ID# 264026
Poway, California, United States, 92064-2530
Actively Recruiting
8
Retina Consultants Of Southern California - Redlands /ID# 276496
Redlands, California, United States, 92374
Actively Recruiting
9
Kaiser Permanente - Riverside Medical Center /ID# 263253
Riverside, California, United States, 92505
Actively Recruiting
10
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
Sacramento, California, United States, 95841
Actively Recruiting
11
UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058
San Francisco, California, United States, 94143-2510
Actively Recruiting
12
Orange County Retina Medical Group /ID# 266612
Santa Ana, California, United States, 92705
Actively Recruiting
13
Retina Consultants of Southern Colorado /ID# 263284
Colorado Springs, Colorado, United States, 80909
Actively Recruiting
14
Colorado Retina Associates /ID# 263247
Lakewood, Colorado, United States, 80228
Actively Recruiting
15
Advanced Vision Surgery Center /ID# 264208
Longmont, Colorado, United States, 80503
Actively Recruiting
16
Advanced Research, LLC /ID# 276526
Deerfield Beach, Florida, United States, 33064-1346
Actively Recruiting
17
Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
Fort Myers, Florida, United States, 33917
Actively Recruiting
18
Florida Eye Specialists /ID# 276612
Jacksonville, Florida, United States, 32256
Not Yet Recruiting
19
Florida Retina Institute - Lake Mary /ID# 263288
Lake Mary, Florida, United States, 32746
Actively Recruiting
20
New Vision Eye Center /ID# 276971
Vero Beach, Florida, United States, 32960
Not Yet Recruiting
21
Center for Retina and Macular Disease /ID# 264201
Winter Haven, Florida, United States, 33880
Actively Recruiting
22
Southeast Retina Center /ID# 263264
Augusta, Georgia, United States, 30909
Actively Recruiting
23
Georgia Retina - Marietta /ID# 266850
Marietta, Georgia, United States, 30060
Not Yet Recruiting
24
Retina Consultants of Hawaii, Inc. /ID# 266359
‘Aiea, Hawaii, United States, 96701
Not Yet Recruiting
25
Springfield Clinic Main Campus /ID# 265202
Springfield, Illinois, United States, 62703-2403
Actively Recruiting
26
Midwest Eye Institute North Indianapolis /ID# 264031
Carmel, Indiana, United States, 46290
Actively Recruiting
27
Wolfe Eye Clinic - West Des Moines /ID# 263270
West Des Moines, Iowa, United States, 50266
Actively Recruiting
28
Maine Eye Center - Marginal Way Campus /ID# 263251
Portland, Maine, United States, 04101
Actively Recruiting
29
The Retina Care Center /ID# 263263
Baltimore, Maryland, United States, 21209
Actively Recruiting
30
Retina Specialist /ID# 264633
Towson, Maryland, United States, 21204
Actively Recruiting
31
Associated Retinal Consultants /ID# 263289
Royal Oak, Michigan, United States, 48073
Actively Recruiting
32
Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427
Edina, Minnesota, United States, 55435
Actively Recruiting
33
Mayo Clinic - Minnesota /ID# 263977
Rochester, Minnesota, United States, 55905
Actively Recruiting
34
Retina Institute - St. Louis /ID# 263985
St Louis, Missouri, United States, 63128
Actively Recruiting
35
Monmouth Retina Consultants /ID# 279252
Little Silver, New Jersey, United States, 07739
Actively Recruiting
36
Cleveland Clinic - Cleveland /ID# 264210
Cleveland, Ohio, United States, 44195
Actively Recruiting
37
Midwest Retina /ID# 263231
Dublin, Ohio, United States, 43016
Actively Recruiting
38
Erie Retina Research /ID# 263287
Erie, Pennsylvania, United States, 16507
Actively Recruiting
39
Charleston Neuroscience Institute - Bluffton /ID# 264037
Bluffton, South Carolina, United States, 29910
Actively Recruiting
40
Charleston Neuroscience Institute - Charleston /ID# 276425
Charleston, South Carolina, United States, 29414
Actively Recruiting
41
Retina Consultants of South Carolina - Ladson /ID# 277596
Ladson, South Carolina, United States, 29456
Actively Recruiting
42
Retina Consultants of America /ID# 264038
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
43
Palmetto Retina Center - West Columbia /ID# 263254
West Columbia, South Carolina, United States, 29169
Not Yet Recruiting
44
Tennessee Retina /ID# 263238
Nashville, Tennessee, United States, 37203
Not Yet Recruiting
45
Retina Research Institute of Texas /ID# 263233
Abilene, Texas, United States, 79606
Actively Recruiting
46
Austin Retina Associates - Austin /ID# 266770
Austin, Texas, United States, 78705
Actively Recruiting
47
Austin Clinical Research, LLC /ID# 263229
Austin, Texas, United States, 78750-2298
Actively Recruiting
48
Star Retina /ID# 266386
Burleson, Texas, United States, 76028
Actively Recruiting
49
Retina Consultants of Texas /ID# 263274
Houston, Texas, United States, 77056-3030
Actively Recruiting
50
Austin Retina Associates - Round Rock /ID# 266776
Round Rock, Texas, United States, 78681
Actively Recruiting
51
Retina Consultants of Texas - Westover /ID# 264209
San Antonio, Texas, United States, 78251
Actively Recruiting
52
Rocky Mountain Retina Consultants /ID# 263266
Murray, Utah, United States, 84107
Actively Recruiting
53
Spokane Eye Clinic /ID# 276934
Spokane, Washington, United States, 99204
Not Yet Recruiting
54
Medizinische Universitaet Graz /ID# 264511
Graz, Styria, Austria, 8010
Actively Recruiting
55
Medizinische Universitaet Innsbruck /ID# 264502
Innsbruck, Tyrol, Austria, 6020
Actively Recruiting
56
Kepler Universitaetsklinikum GmbH /ID# 264493
Linz, Upper Austria, Austria, 4020
Actively Recruiting
57
UZ Gent /ID# 261300
Ghent, Oost-Vlaanderen, Belgium, 9000
Actively Recruiting
58
Universitair Ziekenhuis Leuven /ID# 261302
Leuven, Vlaams-Brabant, Belgium, 3000
Actively Recruiting
59
Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729
Burgas, Bulgaria, 8005
Actively Recruiting
60
OCIPSMAED St. Luka /ID# 275727
Plovdiv, Bulgaria, 4002
Actively Recruiting
61
Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730
Sofia, Bulgaria, 1784
Actively Recruiting
62
Medical Center -Vereya /ID# 275728
Stara Zagora, Bulgaria, 6000
Actively Recruiting
63
Retina Centre of Ottawa /ID# 263803
Ottawa, Ontario, Canada, K2B 7E9
Actively Recruiting
64
Klinicki Bolnicki Centar Zagreb /ID# 276047
Grad Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
65
Klinicka Bolnica Sveti Duh /ID# 275871
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
66
Specijalna bolnica Svjetlost /ID# 276051
Zagreb, City of Zagreb, Croatia, 10000
Actively Recruiting
67
Ustredni vojenska nemocnice - Vojenska fakultni nemocnice Praha /ID# 264663
Prague, Praha 6, Czechia, 169 02
Actively Recruiting
68
Fakultni nemocnice Kralovske Vinohrady /ID# 264660
Prague, Czechia, 100 34
Actively Recruiting
69
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 265073
Nice, Alpes-Maritimes, France, 06001
Actively Recruiting
70
Hopital Edouard Herriot /ID# 265072
Lyon, Auvergne-Rhône-Alpes, France, 69003
Actively Recruiting
71
CHU Bordeaux - Hopital Pellegrin /ID# 265123
Bordeaux, New Aquitaine, France, 33076
Actively Recruiting
72
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265077
Nantes, Pays de la Loire Region, France, 44000
Actively Recruiting
73
Centre Hospitalier Intercommunal de Creteil /ID# 265080
Créteil, Val-de-Marne, France, 94010
Actively Recruiting
74
Centre Monticelli Paradis d'Ophtalmologie /ID# 265120
Marseille, France, 13008
Actively Recruiting
75
Clinique Jules Verne /ID# 265076
Nantes, France, 44314
Actively Recruiting
76
Hôpital Fondation Adolphe de Rothschild /ID# 265081
Paris, France, 75019
Actively Recruiting
77
Centre Hospitalier National d'Ophtalmologie Quinze-Vingts /ID# 265125
Paris, Île-de-France Region, France, 75571
Actively Recruiting
78
Universitaetsklinikum Freiburg /ID# 275449
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
79
Universitaetsklinikum Tuebingen /ID# 264283
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
80
LMU Klinikum - Campus Innenstadt /ID# 264285
Munich, Bavaria, Germany, 80336
Actively Recruiting
81
Universitaetsmedizin Goettingen - Georg-August-Universitaet /ID# 264282
Göttingen, Lower Saxony, Germany, 37075
Actively Recruiting
82
Medizinische Hochschule Hannover /ID# 264281
Hanover, Lower Saxony, Germany, 30625
Actively Recruiting
83
Universitaetsklinikum Bonn /ID# 264279
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
84
Klinikum Ludwigshafen /ID# 275448
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67063
Actively Recruiting
85
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284
Lübeck, Schleswig-Holstein, Germany, 23538
Actively Recruiting
86
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 266366
Berlin, Germany, 12203
Actively Recruiting
87
Universitaetsklinikum Hamburg-Eppendorf /ID# 264280
Hamburg, Germany, 20246
Actively Recruiting
88
General Hospital of Athens G. Gennimatas /ID# 264243
Athens, Attica, Greece, 11527
Actively Recruiting
89
University General Hospital Attikon /ID# 264914
Athens, Attica, Greece, 12462
Actively Recruiting
90
University General Hospital of Larissa /ID# 264247
Larissa, Greece, 41110
Actively Recruiting
91
Ganglion Orvosi Kozpont /ID# 265210
Pécs, Baranya, Hungary, 7621
Actively Recruiting
92
Debreceni Egyetem-Klinikai Kozpont /ID# 265453
Debrecen, Hajdú-Bihar, Hungary, 4032
Actively Recruiting
93
Budapest Retina Associates /ID# 265208
Budapest, Hungary, 1133
Actively Recruiting
94
Edith Wolfson Medical Center /ID# 266304
Holon, Central District, Israel, 5822012
Actively Recruiting
95
Rabin Medical Center /ID# 266449
Petah Tikva, Central District, Israel, 4941492
Actively Recruiting
96
Kaplan Medical Center /ID# 264399
Rehovot, Central District, Israel, 7660101
Actively Recruiting
97
Yitzhak Shamir Medical Center /ID# 275679
Ẕerifin, Central District, Israel, 70300
Actively Recruiting
98
The Chaim Sheba Medical Center /ID# 264700
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
99
Tel Aviv Sourasky Medical Center /ID# 266246
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
100
The Lady Davis Carmel Medical Center /ID# 265618
Haifa, Israel, 34362
Actively Recruiting
101
Hadassah Medical Center-Hebrew University /ID# 264300
Jerusalem, Israel, 91120
Actively Recruiting
102
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 276017
Cona, Ferrara, Italy, 44124
Actively Recruiting
103
Azienda Ospedaliero Universitaria Careggi /ID# 265739
Florence, Firenze, Italy, 50134
Actively Recruiting
104
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 276032
Rome, Roma, Italy, 00168
Actively Recruiting
105
Azienda Ospedaliero Universitaria delle Marche /ID# 265305
Ancona, Italy, 60126
Actively Recruiting
106
AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 265732
Reggio Emilia, Italy, 42122
Actively Recruiting
107
Unidade Local de Saude de Coimbra /ID# 264657
Coimbra, Portugal, 3000-075
Actively Recruiting
108
Unidade Local de Saude de Sao Jose, EPE /ID# 264655
Lisbon, Portugal, 1150-199
Actively Recruiting
109
Unidade Local de Saude de Santo Antonio /ID# 264658
Porto, Portugal, 4099-003
Actively Recruiting
110
Emanuelli Research & Development Center /ID# 264350
Arecibo, Puerto Rico, 00612
Actively Recruiting
111
Hospital Arruzafa /ID# 280175
Córdoba, Cordoba, Spain, 14012
Actively Recruiting
112
Hospital Universitario De Donostia /ID# 263155
Donostia / San Sebastian, Guipuzcoa, Spain, 20014
Actively Recruiting
113
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179
Majadahonda, Madrid, Spain, 28222
Actively Recruiting
114
Instituto Oftalmológico Fernández-Vega /ID# 263157
Asturias, Principality of Asturias, Spain, 33012
Actively Recruiting
115
Hospital Universitario Virgen Macarena /ID# 263180
Seville, Sevilla, Spain, 41009
Actively Recruiting
116
Centre d'Oftalmologia Barraquer /ID# 266631
Barcelona, Spain, 08021
Actively Recruiting
117
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152
Barcelona, Spain, 08028
Actively Recruiting
118
Hospital Universitari Vall d'Hebron /ID# 263301
Barcelona, Spain, 08035
Actively Recruiting
119
Hospital Universitario 12 de Octubre /ID# 263544
Madrid, Spain, 28041
Actively Recruiting
120
Hospital Universitari i Politecnic La Fe /ID# 263441
Valencia, Spain, 46026
Actively Recruiting
121
Hospital Clinico Universitario Lozano Blesa /ID# 263158
Zaragoza, Spain, 50009
Actively Recruiting
122
Gloucestershire Royal Hospital /ID# 276072
Gloucester, Gloucestershire, United Kingdom, GL1 3NN
Actively Recruiting
123
Moorfields Eye Hospital /ID# 267227
London, Greater London, United Kingdom, EC1V 2PD
Actively Recruiting
124
The Retina Clinic London /ID# 266156
London, Greater London, United Kingdom, W1G 7LB
Actively Recruiting
125
Liverpool University Hospitals NHS Foundation Trust /ID# 265854
Liverpool, Merseyside, United Kingdom, L9 7AL
Actively Recruiting
126
Bristol Eye Hospital /ID# 266155
Bristol, United Kingdom, BS1 2LX
Actively Recruiting
127
Manchester Royal Eye Hospital /ID# 266153
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
128
Sunderland Royal Hospital /ID# 266664
Sunderland, United Kingdom, SR4 7TN
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
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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