Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

PHASE3RecruitingINTERVENTIONAL
Enrollment

660

Participants

Timeline

Start Date

January 13, 2022

Primary Completion Date

October 31, 2026

Study Completion Date

November 30, 2027

Conditions
AMDnAMDWet Age-related Macular DegenerationwAMDWetAMDCNV
Interventions
GENETIC

ABBV-RGX-314 Dose 1

AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)

GENETIC

ABBV-RGX-314 Dose 2

AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)

BIOLOGICAL

Aflibercept (EYLEA®)

2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections

Trial Locations (181)

1133

RECRUITING

Budapest Retina Intezet /ID# 262647, Budapest

4032

RECRUITING

Debreceni Egyetem-Klinikai Kozpont /ID# 262646, Debrecen

7621

RECRUITING

Ganglion Orvosi Központ /ID# 264550, Pécs

10032

RECRUITING

Columbia University of New York - Edward S. Harkness Eye Institute /ID# 256342, New York

13008

RECRUITING

Clinique Juge /ID# 262417, Marseille

14012

RECRUITING

Hospital Arruzafa /ID# 262634, Córdoba

14620

COMPLETED

Retina Associates of Western New York /ID# 256374, Rochester

15213

ACTIVE_NOT_RECRUITING

University of Pittsburgh Medical Center /ID# 258994, Pittsburgh

15706

RECRUITING

Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262632, Santiago de Compostela

19107

RECRUITING

Mid Atlantic Retina /ID# 256232, Philadelphia

20132

RECRUITING

IRCCS Ospedale San Raffaele /ID# 263035, Milan

20157

RECRUITING

ASST Fatebenefratelli Sacco /ID# 263273, Milan

20246

RECRUITING

Universitaetsklinikum Hamburg-Eppendorf /ID# 262493, Hamburg

21000

RECRUITING

CHU Dijon /ID# 262410, Dijon

21204

ACTIVE_NOT_RECRUITING

Greater Baltimore Medical Ctr /ID# 256392, Baltimore

21287

COMPLETED

Johns Hopkins Hospital /ID# 256236, Baltimore

23235

RECRUITING

Retina Institute of Virginia /ID# 256394, Richmond

23502

RECRUITING

Wagner Macula & Retina Center - Norfolk /ID# 256260, Norfolk

24011

RECRUITING

Vistar Eye Center /ID# 271024, Roanoke

24502

COMPLETED

Piedmont Eye Center /ID# 256386, Lynchburg

27705

RECRUITING

Duke Eye Center /ID# 256245, Durham

28041

RECRUITING

Hospital Universitario 12 de Octubre /ID# 262636, Madrid

28046

RECRUITING

Clinica Baviera /ID# 270146, Madrid

28222

RECRUITING

Hospital Universitario Puerta de Hierro - Majadahonda /ID# 262635, Majadahonda

28602

RECRUITING

Graystone Eye /ID# 256424, Hickory

28803

RECRUITING

Western Carolina Retinal Associates /ID# 256355, Asheville

29501

COMPLETED

Palmetto Retina Center-Florence /ID# 256244, Florence

30060

RECRUITING

Georgia Retina - Marietta /ID# 256264, Marietta

31059

RECRUITING

Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 262411, Toulouse

32503

RECRUITING

Retina Specialty Institute /ID# 256268, Pensacola

32607

RECRUITING

Vitreoretinal Associates, P.A. /ID# 256266, Gainesville

33064

COMPLETED

Duplicate_Rand Eye Institute /ID# 256337, Deerfield Beach

33100

RECRUITING

ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 263036, Udine

33324

COMPLETED

Fort Lauderdale Eye Institute /ID# 266011, Plantation

33805

RECRUITING

Florida Retina Consultants /ID# 256321, Lakeland

33880

RECRUITING

Center for Retina and Macular Disease /ID# 256335, Winter Haven

35016

RECRUITING

Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 262633, Las Palmas de Gran Canaria

37024

RECRUITING

IRCCS Ospedale Sacro Cuore Don Calabria /ID# 263536, Negrar

37421

RECRUITING

Southeastern Retina Associates - Chattanooga /ID# 258992, Chattanooga

37604

RECRUITING

Southeastern Retina Associates - Johnson City /ID# 256396, Johnson City

38138

RECRUITING

Charles Retina Institute /ID# 256237, Germantown

43016

RECRUITING

Midwest Retina /ID# 276644, Dublin

43210

RECRUITING

Ohio State University /ID# 256275, Columbus

44000

RECRUITING

Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 262408, Nantes

44124

RECRUITING

Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 262896, Cona

44130

ACTIVE_NOT_RECRUITING

Retina Associates of Cleveland-Middleburg Heights /ID# 256280, Cleveland

44195

COMPLETED

Cleveland Clinic - Cleveland /ID# 256282, Cleveland

46290

RECRUITING

Retina Partners Midwest, PC /ID# 256277, Indianapolis

48073

RECRUITING

Associated Retinal Consultants /ID# 256269, Royal Oak

48149

RECRUITING

Universitaetsklinikum Muenster /ID# 262499, Münster

48439

RECRUITING

Retina Associates of Michigan /ID# 256393, Grand Blanc

50266

RECRUITING

Wolfe Eye Clinic - West Des Moines /ID# 256314, West Des Moines

53127

RECRUITING

Universitaetsklinikum Bonn /ID# 262498, Bonn

54601

RECRUITING

Gundersen Health System - La Crosse Medical Center /ID# 276012, La Crosse

55435

RECRUITING

VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256272, Edina

57701

RECRUITING

Black Hills Regional Eye Institute /ID# 262872, Rapid City

60304

RECRUITING

Illinois Retina Associates-Oak Park Office /ID# 256375, Chicago

60439

RECRUITING

University Retina and Macula Associates /ID# 256288, Lemont

60452

COMPLETED

University Retina and Macula Associates /ID# 256287, Oak Forest

63017

COMPLETED

Midwest Vision Research Foundation at Pepose Vision Institute /ID# 258993, Chesterfield

63130

RECRUITING

Washington University School of Medicine - St. Louis /ID# 256383, St Louis

65212

RECRUITING

University of Missouri Hospital /ID# 262474, Columbia

66215

RECRUITING

Retina Associates - Lenexa /ID# 258296, Lenexa

66346

RECRUITING

Knappschaftsklinikum Saar /ID# 262496, Püttlingen

67063

RECRUITING

Klinikum Ludwigshafen /ID# 262497, Ludwigshafen am Rhein

67100

RECRUITING

ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 263923, Chieti

69004

RECRUITING

Hôpital de la Croix Rousse - Groupement Hospitalier Nord /ID# 262409, Lyon

70124

RECRUITING

A.O.U. Consorziale Policlinico di Bari /ID# 262500, Bari

73013

RECRUITING

Retina Vitreous Center, Research /ID# 256284, Edmond

75010

RECRUITING

AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 262406, Paris

75231

RECRUITING

Ophthalmology Surgery Center of Dallas /ID# 256259, Dallas

75679

RECRUITING

Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 262415, Paris

76028

RECRUITING

Star Retina - Burleson /ID# 256376, Burleson

76092

RECRUITING

Retina Center Of Texas (Rct) - Southlake /ID# 256281, Southlake

76104

ACTIVE_NOT_RECRUITING

Texas Retina Associates - Fort Worth /ID# 256326, Fort Worth

77401

RECRUITING

Retina Consultants of Texas - Bellaire /ID# 256377, Bellaire

78240

RECRUITING

Stone Oak Surgery Center /ID# 256381, San Antonio

78251

RECRUITING

Brown Retina Institute /ID# 256382, San Antonio

78681

RECRUITING

Austin Retina Associates - Round Rock /ID# 256387, Round Rock

78705

RECRUITING

Austin Research Center for Retina /ID# 256265, Austin

79106

ACTIVE_NOT_RECRUITING

Universitaetsklinikum Freiburg /ID# 262495, Freiburg im Breisgau

80138

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 264074, Naples

80228

COMPLETED

Colorado Retina Associates /ID# 256378, Lakewood

80503

RECRUITING

Eye Care Center of Northern Colorado-Longmont /ID# 256380, Longmont

80909

RECRUITING

Retina Consultants of Southern Colorado /ID# 256285, Colorado Springs

81303

RECRUITING

Southwest Retina Research Center /ID# 256261, Durango

82017

RECRUITING

Clinique Honoré Cave /ID# 262225, Montauban

84107

RECRUITING

Rocky Mountain Retina Consultants /ID# 256369, Murray

RECRUITING

Retina Associates of Utah /ID# 256276, Salt Lake City

85016

RECRUITING

Barnet Dulaney Eye Center-Phoenix /ID# 256340, Phoenix

85053

RECRUITING

Retinal Research Institute /ID# 256238, Phoenix

89081

RECRUITING

Universitaetsklinikum Ulm /ID# 262494, Ulm

89502

COMPLETED

Sierra Eye Associates /ID# 256239, Reno

90211

RECRUITING

Retina Vitreous Assoc Med Grp /ID# 256246, Beverly Hills

90503

RECRUITING

Macula Retina Vitreous Center - Torrance /ID# 270247, Torrance

91436

RECRUITING

The Retina Partners - Encino /ID# 259660, Encino

92093

RECRUITING

Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 256320, La Jolla

92505

RECRUITING

Kaiser Permanente - Riverside Medical Center /ID# 262413, Riverside

92705

RECRUITING

Orange County Retina Medical Group /ID# 256286, Santa Ana

92835

RECRUITING

Retina Consultants of Orange County /ID# 256267, Fullerton

93036

RECRUITING

California Retina Consultants - Oxnard - North Ventura Road /ID# 262883, Oxnard

94000

RECRUITING

Centre Hosp Intercommunal de Creteil /ID# 262407, Créteil

94303

RECRUITING

Byers Eye Institute Stanford /ID# 262853, Palo Alto

94598

RECRUITING

Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513, Walnut Creek

95008

RECRUITING

Retinal Diagnostic Center /ID# 256262, Campbell

95817

RECRUITING

University of California Davis Health /ID# 256317, Sacramento

95841

RECRUITING

Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353, Sacramento

96701

RECRUITING

Retina Consultants of Hawaii /ID# 256278, ‘Aiea

98004

COMPLETED

Pacific Northwest Retina /ID# 258999, Bellevue

98383

RECRUITING

Retina Center NW, PLLC /ID# 256395, Silverdale

99204

RECRUITING

Spokane Eye Clinic /ID# 256338, Spokane

85255-4134

RECRUITING

Retina Macula Institute of Arizona /ID# 271026, Scottsdale

93309-1677

RECRUITING

California Retina Consultants - Bakersfield /ID# 256240, Bakersfield

92064-2530

RECRUITING

Retina Consultants of San Diego /ID# 256258, Poway

06042-3556

RECRUITING

Retina Consultants, P.C. /ID# 273610, Manchester

33912-7125

RECRUITING

National Ophthalmic Research Institute /ID# 256344, Fort Myers

32806-1101

RECRUITING

Florida Retina Institute - Orlando /ID# 256373, Orlando

33711-1141

RECRUITING

Retina Vitreous Associates of Florida - St. Petersburg /ID# 256279, St. Petersburg

60611-2987

RECRUITING

Northwestern Medicine Fertility and Reproductive Medicine /ID# 256379, Chicago

62702-3749

RECRUITING

Springfield Clinic /ID# 256371, Springfield

47150-3620

ACTIVE_NOT_RECRUITING

John-Kenyon American Eye Institute -New Albany /ID# 256283, New Albany

04101

RECRUITING

Maine Eye Center - Marginal Way Campus /ID# 256391, Portland

21740-5965

ACTIVE_NOT_RECRUITING

Mid Atlantic Retina Specialists - Hagerstown /ID# 256310, Hagerstown

02114

RECRUITING

MA Eye & Ear Infirmary /ID# 262430, Boston

RECRUITING

Ophthalmic Consultants of Boston /ID# 256233, Boston

01605

RECRUITING

Vitreo Retinal Associates - Worcester /ID# 266008, Worcester

55905-0001

RECRUITING

Mayo Clinic - Rochester /ID# 258295, Rochester

39110-2028

RECRUITING

Mississippi Retina Associates /ID# 270934, Madison

07003

RECRUITING

Envision Ocular, LLC /ID# 256367, Bloomfield

07739

RECRUITING

Monmouth Retina Consultants /ID# 275895, Little Silver

45242-5664

RECRUITING

Cincinnati Eye Institute /ID# 256247, Blue Ash

19104-5502

RECRUITING

University of Pennsylvania /ID# 258995, Philadelphia

29902-6216

RECRUITING

Charleston Neuroscience Institute - Beaufort /ID# 256385, Beaufort

29414-5896

RECRUITING

Charleston Neurosciences Institute /ID# 256336, Charleston

RECRUITING

Charleston Neurosciences Institute /ID# 256351, Charleston

37203-1513

RECRUITING

Tennessee Retina - Nashville /ID# 256388, Nashville

37232-0011

RECRUITING

Vanderbilt University Medical Center /ID# 256372, Nashville

79606-1224

COMPLETED

Retina Research Institute of Texas /ID# 256263, Abilene

78750-2298

COMPLETED

Austin Clinical Research, LLC /ID# 256274, Austin

78240-1655

RECRUITING

RCTX - San Antonio Retina Center /ID# 259661, San Antonio

T2H 0C8

RECRUITING

Calgary Retina Consultants /ID# 258997, Calgary

T5H 0X5

RECRUITING

Alberta Retina Consultants /ID# 265599, Edmonton

V3L 5H1

RECRUITING

Retina Surgical Associates /ID# 270958, New Westminster

V5Z 3N9

RECRUITING

University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 266014, Vancouver

M8X 2X3

COMPLETED

Vitreous Retina Macula Specialists of Toronto /ID# 258299, Etobicoke

K1H 8L6

RECRUITING

Ottawa Hospital Research Institute /ID# 258998, Ottawa

K2B 7E9

RECRUITING

Retina Centre of Ottawa /ID# 259659, Ottawa

M3C 0G9

RECRUITING

Toronto Retina Institute /ID# 265602, Toronto

M4N 3M5

RECRUITING

Sunnybrook Health Sciences Centre /ID# 270690, Toronto

G1R 2J6

COMPLETED

Duplicate_CHU de Quebec-Universite Laval /ID# 258996, Québec

06001

RECRUITING

Centre Hospitalier Universitaire de Nice - Hôpital Pasteur /ID# 262418, Nice

00168

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 263037, Rome

00184

RECRUITING

IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 262897, Rome

466-8560

RECRUITING

Nagoya University Hospital /ID# 267350, Nagoya

960-1295

RECRUITING

Fukushima Medical University Hospital /ID# 258411, Fukushima

650-0047

RECRUITING

Kobe City Eye Hospital /ID# 256948, Kobe

663-8501

RECRUITING

Hyogo Medical University Hospital /ID# 257893, Nishinomiya-shi

890-8520

RECRUITING

Kagoshima University Hospital /ID# 257053, Kagoshima

606-8507

RECRUITING

Kyoto University Hospital /ID# 267351, Kyoto

889-1692

RECRUITING

University of Miyazaki Hospital /ID# 262879, Miyazaki

520-2192

RECRUITING

Shiga University of Medical Science /ID# 266862, Ōtsu

113-8431

RECRUITING

Juntendo University Hospital /ID# 258715, Bunkyo-ku

00612

RECRUITING

Emanuelli Research & Development Center LLC /ID# 256231, Arecibo

08907

RECRUITING

Hospital Universitari de Bellvitge /ID# 262641, L'Hospitalet de Llobregat

08028

RECRUITING

Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 262644, Barcelona

08035

RECRUITING

Instituto de Microcirugía Ocular /ID# 262642, Barcelona

08041

RECRUITING

Hospital Santa Creu i Sant Pau /ID# 262637, Barcelona

HP21 8AL

RECRUITING

Stoke Mandeville Hospital /ID# 277343, Aylesbury

W12 0HS

RECRUITING

Hammersmith Hospital /ID# 271621, London

GL1 3NN

RECRUITING

Gloucestershire Royal Hospital /ID# 277362, Gloucester

EC1V 2PD

RECRUITING

Moorfields Eye Hospital /ID# 263038, London

W1G 7LB

RECRUITING

The Retina Clinic London /ID# 262304, London

SO16 6YD

RECRUITING

University Hospital Southampton NHS Foundation Trust /ID# 262307, Southampton

OX3 9DU

RECRUITING

Oxford University Hospitals NHS Foundation Trust /ID# 262306, Oxford

LS9 7TF

RECRUITING

Leeds Teaching Hospitals NHS Trust /ID# 277366, Leeds

BD9 6RJ

RECRUITING

Bradford Royal Infirmary /ID# 273164, Bradford

BS1 2LX

RECRUITING

Bristol Eye Hospital /ID# 271619, Bristol

L7 8XP

RECRUITING

Liverpool University Hospitals NHS Foundation Trust /ID# 262305, Liverpool

M9 2AA

RECRUITING

Manchester University NHS Foundation Trust /ID# 262404, Manchester

NE1 4LP

RECRUITING

Royal Victoria Infirmary /ID# 277368, Newcastle upon Tyne

SR2 9HP

RECRUITING

Sunderland Eye Infirmary /ID# 271620, Sunderland

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

REGENXBIO Inc.

INDUSTRY

lead

AbbVie

INDUSTRY