Actively Recruiting

Phase 3
Age: 50Years +
All Genders
ID07007065

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

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

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
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
  • 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

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

Follow-up

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

Loading map...

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

Similar Trials

An Open-label Dose-escalation Study to Evaluate Safety, Prel...

Neovascular Age-related Macular Degeneration

Actively Recruiting

3 locations

Real-World, Long-Term Data Collection to Gain Clinical Insig...

Neovascular Age-related Macular Degeneration

Actively Recruiting

59 locations

A Phase 1/2 Dose Escalation and Dose Expansion Study to Eval...

Neovascular Age-related Macular Degeneration

Actively Recruiting

18 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here