Actively Recruiting

Phase 3
Age: 50Years +
All Genders
NCT07007065

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

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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