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Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
Sponsor: AbbVie
Summary
ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.
Official title: A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD
Key Details
Gender
All
Age Range
50 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
735
Start Date
2022-01-13
Completion Date
2027-11
Last Updated
2026-08-03
Healthy Volunteers
No
Interventions
ABBV-RGX-314 Dose 1
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
ABBV-RGX-314 Dose 2
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
Aflibercept (EYLEA®)
2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections
Locations (181)
Barnet Dulaney Eye Center-Phoenix /ID# 256340
Phoenix, Arizona, United States
Retinal Research Institute /ID# 256238
Phoenix, Arizona, United States
Retina Macula Institute of Arizona /ID# 271026
Scottsdale, Arizona, United States
California Retina Consultants - Bakersfield /ID# 256240
Bakersfield, California, United States
Retina Vitreous Assoc Med Grp /ID# 256246
Beverly Hills, California, United States
Retinal Diagnostic Center /ID# 256262
Campbell, California, United States
The Retina Partners - Encino /ID# 259660
Encino, California, United States
Retina Consultants of Orange County /ID# 256267
Fullerton, California, United States
Jacobs Retina Center at UCSD/ID# 256320
La Jolla, California, United States
California Retina Consultants - Oxnard - North Ventura Road /ID# 262883
Oxnard, California, United States
Byers Eye Institute Stanford /ID# 262853
Palo Alto, California, United States
Retina Consultants of San Diego /ID# 256258
Poway, California, United States
Kaiser Permanente - Riverside Medical Center /ID# 262413
Riverside, California, United States
UC Davis Health Eye Center
Sacramento, California, United States
Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353
Sacramento, California, United States
Orange County Retina Medical Group /ID# 256286
Santa Ana, California, United States
Macula Retina Vitreous Center - Torrance /ID# 270247
Torrance, California, United States
Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513
Walnut Creek, California, United States
Retina Consultants of Southern Colorado /ID# 256285
Colorado Springs, Colorado, United States
Southwest Retina Research Center /ID# 256261
Durango, Colorado, United States
Colorado Retina Associates /ID# 256378
Lakewood, Colorado, United States
Advanced Vision Research Institute /ID# 256380
Longmont, Colorado, United States
Retina Consultants, P.C. /ID# 273610
Manchester, Connecticut, United States
Rand Eye Institute /ID# 256337
Deerfield Beach, Florida, United States
National Ophthalmic Research Institute /ID# 256344
Fort Myers, Florida, United States
Vitreoretinal Associates, P.A. /ID# 256266
Gainesville, Florida, United States
Florida Retina Consultants /ID# 256321
Lakeland, Florida, United States
Florida Retina Institute - Orlando /ID# 256373
Orlando, Florida, United States
Retina Specialty Institute /ID# 256268
Pensacola, Florida, United States
Fort Lauderdale Eye Institute /ID# 266011
Plantation, Florida, United States
Retina Vitreous Associates of Florida - St. Petersburg /ID# 256279
St. Petersburg, Florida, United States
Center for Retina and Macular Disease /ID# 256335
Winter Haven, Florida, United States
Georgia Retina - Marietta /ID# 256264
Marietta, Georgia, United States
Retina Consultants of Hawaii /ID# 256278
‘Aiea, Hawaii, United States
Northwestern Memorial Hospital - Department of Ophthalmology /ID# 256379
Chicago, Illinois, United States
University Retina and Macula Associates /ID# 256288
Lemont, Illinois, United States
University Retina and Macula Associates /ID# 256287
Oak Forest, Illinois, United States
Illinois Retina Associates - Oak Park /ID# 256375
Oak Park, Illinois, United States
Springfield Clinic - First /ID# 256371
Springfield, Illinois, United States
Retina Partners Midwest, PC /ID# 256277
Indianapolis, Indiana, United States
John-Kenyon American Eye Institute -New Albany /ID# 256283
New Albany, Indiana, United States
Wolfe Eye Clinic - West Des Moines /ID# 256314
West Des Moines, Iowa, United States
Retina Associates - Lenexa /ID# 258296
Lenexa, Kansas, United States
Maine Eye Center - Marginal Way Campus /ID# 256391
Portland, Maine, United States
Retina Specialists /ID# 256392
Baltimore, Maryland, United States
Johns Hopkins Hospital /ID# 256236
Baltimore, Maryland, United States
Mid Atlantic Retina Specialists - Hagerstown /ID# 256310
Hagerstown, Maryland, United States
MA Eye & Ear Infirmary /ID# 262430
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston /ID# 256233
Boston, Massachusetts, United States
Vitreo Retinal Associates - Worcester /ID# 266008
Worcester, Massachusetts, United States
Retina Associates of Michigan /ID# 256393
Grand Blanc, Michigan, United States
Associated Retinal Consultants /ID# 256269
Royal Oak, Michigan, United States
VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256272
Edina, Minnesota, United States
Mayo Clinic - Rochester /ID# 258295
Rochester, Minnesota, United States
Mississippi Retina Associates /ID# 270934
Madison, Mississippi, United States
Mid America Surgery Center /ID# 258993
Chesterfield, Missouri, United States
University of Missouri Hospital /ID# 262474
Columbia, Missouri, United States
Washington University School of Medicine - St. Louis /ID# 256383
St Louis, Missouri, United States
Sierra Eye Associates /ID# 256239
Reno, Nevada, United States
Envision Ocular, LLC /ID# 256367
Bloomfield, New Jersey, United States
Monmouth Retina Consultants /ID# 275895
Little Silver, New Jersey, United States
Columbia University of New York - Edward S. Harkness Eye Institute /ID# 256342
New York, New York, United States
Retina Associates of Western New York /ID# 256374
Rochester, New York, United States
Asheville Eye Associates- Retina Division /ID# 256355
Asheville, North Carolina, United States
Duke University Medical Center /ID# 256245
Durham, North Carolina, United States
Graystone Eye /ID# 256424
Hickory, North Carolina, United States
Cincinnati Eye Institute /ID# 256247
Cincinnati, Ohio, United States
Retina Associates of Cleveland-Middleburg Heights /ID# 256280
Cleveland, Ohio, United States
Cleveland Clinic - Cleveland /ID# 256282
Cleveland, Ohio, United States
Ohio State University /ID# 256275
Columbus, Ohio, United States
Midwest Retina /ID# 276644
Dublin, Ohio, United States
Retina Vitreous Center, Research /ID# 256284
Edmond, Oklahoma, United States
University of Pennsylvania /ID# 258995
Philadelphia, Pennsylvania, United States
Mid Atlantic Retina /ID# 256232
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center /ID# 258994
Pittsburgh, Pennsylvania, United States
Charleston Neuroscience Institute - Beaufort /ID# 256385
Beaufort, South Carolina, United States
Charleston Neurosciences Institute /ID# 256351
Charleston, South Carolina, United States
Palmetto Retina Center-Florence /ID# 256244
Florence, South Carolina, United States
Charleston Neurosciences Institute /ID# 256336
Ladson, South Carolina, United States
Black Hills Regional Eye Institute /ID# 262872
Rapid City, South Dakota, United States
Southeastern Retina Associates - Chattanooga /ID# 258992
Chattanooga, Tennessee, United States
Charles Retina Institute /ID# 256237
Germantown, Tennessee, United States
Southeastern Retina Associates - Johnson City /ID# 256396
Johnson City, Tennessee, United States
Tennessee Retina - Nashville /ID# 256388
Nashville, Tennessee, United States
Vanderbilt University Medical Center /ID# 256372
Nashville, Tennessee, United States
Retina Research Institute of Texas /ID# 256263
Abilene, Texas, United States
Austin Research Center for Retina /ID# 256265
Austin, Texas, United States
Austin Clinical Research, LLC /ID# 256274
Austin, Texas, United States
Retina Consultants of Texas - Bellaire /ID# 256377
Bellaire, Texas, United States
Star Retina - Burleson /ID# 256376
Burleson, Texas, United States
Texas Retina Associates /ID# 256259
Dallas, Texas, United States
Texas Retina Associates - Fort Worth /ID# 256326
Fort Worth, Texas, United States
Austin Retina Associates - Round Rock /ID# 256387
Round Rock, Texas, United States
Retina Consultants of Texas/ID# 259661
San Antonio, Texas, United States
Retina Associates of South Texas
San Antonio, Texas, United States
Retina Consultants of Texas /ID# 256382
San Antonio, Texas, United States
Retina Center Of Texas (Rct) - Southlake /ID# 256281
Southlake, Texas, United States
Rocky Mountain Retina Consultants /ID# 256369
Murray, Utah, United States
Retina Associates of Utah /ID# 256276
Salt Lake City, Utah, United States
Piedmont Eye Center /ID# 256386
Lynchburg, Virginia, United States