Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

630

Participants

Timeline

Start Date

December 29, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

November 30, 2027

Conditions
AMDnAMDWet Age-related Macular DegenerationwAMDWet AMDCNVNeovascular AMDNeovascular Age-related Macular DegenerationChoroidal Neovascularization
Interventions
GENETIC

ABBV-RGX-314

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

GENETIC

ABBV-RGX-314

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

BIOLOGICAL

Ranibizumab (LUCENTIS®)

0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days

Trial Locations (89)

11021

COMPLETED

Long Island Vitreoretinal Consultants /ID# 256074, Great Neck

13088

RECRUITING

Retina-Vitreous Surgeons of Central New York - Liverpool /ID# 266274, Liverpool

15146

RECRUITING

Retina Vitreous Consultants - Monroeville /ID# 271654, Monroeville

16507

RECRUITING

Erie Retina Research /ID# 256154, Erie

19107

RECRUITING

Mid Atlantic Retina /ID# 256013, Philadelphia

20815

RECRUITING

The Retina Group Of Washington - Chevy Chase /ID# 276039, Chevy Chase

21209

RECRUITING

The Retina Care Center /ID# 256144, Baltimore

21287

RECRUITING

Johns Hopkins Hospital /ID# 256015, Baltimore

21740

RECRUITING

Cumberland Valley Retina Consultants - Hagerstown /ID# 256151, Hagerstown

23502

RECRUITING

Wagner Macula & Retina Center - Norfolk /ID# 256134, Norfolk

27157

RECRUITING

Atrium Health Wake Forest Baptist Medical Center /ID# 270767, Winston-Salem

27705

RECRUITING

Duke Eye Center /ID# 256076, Durham

29456

RECRUITING

Charleston Neuroscience Institute /ID# 256235, Ladson

30060

RECRUITING

Georgia Retina - Marietta /ID# 256142, Marietta

RECRUITING

Marietta Eye Clinic /ID# 268163, Marietta

30909

RECRUITING

Southeast Retina Center /ID# 256022, Augusta

32308

RECRUITING

Southern Vitreoretinal Associates /ID# 256158, Tallahassee

32503

RECRUITING

Retina Specialty Institute /ID# 256153, Pensacola

32607

RECRUITING

Vitreoretinal Associates, P.A. /ID# 256150, Gainesville

33136

COMPLETED

Bascom Palmer Eye Institute - University of Miami /ID# 256072, Miami

33805

RECRUITING

Florida Retina Consultants /ID# 265661, Lakeland

38138

RECRUITING

Charles Retina Institute /ID# 256016, Germantown

44130

RECRUITING

Retina Associates of Cleveland-Middleburg Heights /ID# 256052, Cleveland

44195

RECRUITING

Cleveland Clinic Main Campus /ID# 256064, Cleveland

46214

RECRUITING

The Retina Institute /ID# 266587, St Louis

46290

RECRUITING

Retina Partners Midwest, PC /ID# 256045, Indianapolis

48073

RECRUITING

Associated Retinal Consultants /ID# 256156, Royal Oak

48439

RECRUITING

Retina Associates of Michigan /ID# 266198, Grand Blanc

55435

RECRUITING

VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256160, Edina

55905

RECRUITING

Mayo Clinic - Minnesota /ID# 256051, Rochester

57701

RECRUITING

Black Hills Regional Eye Institute /ID# 256161, Rapid City

60439

RECRUITING

University Retina and Macula Associates /ID# 256078, Lemont

60452

RECRUITING

University Retina and Macula Associates /ID# 256077, Oak Forest

60607

COMPLETED

University of Illinois at Chicago /ID# 256300, Chicago

66215

RECRUITING

Retina Associates - Lenexa /ID# 256080, Lenexa

70121

RECRUITING

Ochsner Medical Center - Jefferson Highway /ID# 270524, New Orleans

72205

RECRUITING

University of Arkansas for Medical Sciences /ID# 271290, Little Rock

73013

RECRUITING

Retina Vitreous Center, Research /ID# 256067, Edmond

75231

RECRUITING

Texas Retina Associates - Dallas /ID# 256133, Dallas

76092

RECRUITING

Retina Center Of Texas (Rct) - Southlake /ID# 256056, Southlake

76104

RECRUITING

Baylor Scott & White Surgicare /ID# 256122, Fort Worth

77384

RECRUITING

Retina Consultants - The Woodlands /ID# 256018, The Woodlands

77401

RECRUITING

Retina and Vitreous of Texas /ID# 263961, Bellaire

77707

RECRUITING

Retina Consultants of Texas - Beaumont /ID# 266279, Beaumont

78240

RECRUITING

Retina Consultants Of Texas /ID# 268611, San Antonio

COMPLETED

Stone Oak Surgery Center /ID# 266199, San Antonio

78705

RECRUITING

Austin Research Center for Retina /ID# 256148, Austin

RECRUITING

Austin Retina Associates - Austin /ID# 256053, Austin

80228

RECRUITING

Colorado Retina Associates /ID# 256121, Lakewood

80909

RECRUITING

Retina Consultants of Southern Colorado /ID# 256069, Colorado Springs

81303

RECRUITING

Southwest Retina Research Center /ID# 256136, Durango

84107

RECRUITING

Retina Associates of Utah /ID# 256044, Salt Lake City

84132

RECRUITING

John A. Moran Eye Center /ID# 256068, Salt Lake City

85053

RECRUITING

Retinal Research Institute /ID# 256019, Phoenix

85351

RECRUITING

Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055, Sun City

87109

RECRUITING

Eye Associates of New Mexico /ID# 256075, Albuquerque

89502

RECRUITING

Sierra Eye Associates /ID# 256020, Reno

90211

RECRUITING

Retina Vitreous Assoc Med Grp /ID# 256299, Beverly Hills

91105

RECRUITING

UCLA Doheny Eye Center /ID# 256120, Pasadena

91107

RECRUITING

California Eye Specialists Medical Group Inc. /ID# 256079, Pasadena

91436

RECRUITING

The Retina Partners - Encino /ID# 256054, Encino

92647

RECRUITING

Salehi Retina Institute /ID# 263485, Huntington Beach

92697

COMPLETED

UC Irvine/Gavin Herbert Eye Institute /ID# 256145, Irvine

92705

RECRUITING

Orange County Retina Medical Group /ID# 256073, Santa Ana

92835

RECRUITING

Retina Consultants of Orange County /ID# 256152, Fullerton

93103

COMPLETED

California Retina Consultants - Santa Barbara /ID# 256017, Santa Barbara

94107

RECRUITING

West Coast Retina /ID# 256448, San Francisco

94143

RECRUITING

University of California, San Francisco /ID# 256130, San Francisco

95008

RECRUITING

Retinal Diagnostic Center /ID# 256137, Campbell

95825

RECRUITING

Retinal Consultants Medical Group /ID# 256047, Sacramento

96701

RECRUITING

Retina Consultants of Hawaii /ID# 256049, ‘Aiea

97221

RECRUITING

Retina Northwest, PC /ID# 256140, Portland

97401

RECRUITING

Verum Research, LLC /ID# 266585, Eugene

98004

COMPLETED

Pacific Northwest Retina /ID# 256155, Bellevue

98383

RECRUITING

Retina Center NW, PLLC /ID# 256157, Silverdale

94040-4101

RECRUITING

Northern California Retina Vitreous Associates Medical Group, Inc /ID# 256298, Mountain View

92064-2530

RECRUITING

Retina Consultants of San Diego /ID# 256021, Poway

06385-1215

COMPLETED

Retina Group of New England - Waterford /ID# 256071, Waterford

33064-1342

RECRUITING

Advanced Research, LLC /ID# 275451, Deerfield Beach

33711-1141

RECRUITING

Retina Vitreous Associates of Florida - St. Petersburg /ID# 256050, St. Petersburg

30328-4411

RECRUITING

Thomas Eye Group PC /ID# 268159, Sandy Springs

62702-3749

RECRUITING

Springfield Clinic /ID# 266225, Springfield

47150-3620

RECRUITING

John-Kenyon American Eye Institute -New Albany /ID# 256065, New Albany

41017-3415

RECRUITING

Cincinnati Eye Institute- Edgewood /ID# 256132, Edgewood

70006-2940

RECRUITING

Retina Associates of New Orleans /ID# 272440, Metairie

02114

RECRUITING

Ophthalmic Consultants of Boston /ID# 256014, Boston

79606-1224

RECRUITING

Retina Research Institute of Texas /ID# 256141, Abilene

78750-2298

RECRUITING

Austin Clinical Research, LLC /ID# 256043, Austin

53705-3644

COMPLETED

University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences /ID# 256159, Madison

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

REGENXBIO Inc.

INDUSTRY

lead

AbbVie

INDUSTRY