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Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
Sponsor: AbbVie
Summary
ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD or nAMD). 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 (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.
Official title: A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)
Key Details
Gender
All
Age Range
50 Years - 89 Years
Study Type
INTERVENTIONAL
Enrollment
630
Start Date
2020-12-29
Completion Date
2027-11
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
ABBV-RGX-314
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
ABBV-RGX-314
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
Ranibizumab (LUCENTIS®)
0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days
Locations (89)
Retinal Research Institute /ID# 256019
Phoenix, Arizona, United States
Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055
Sun City, Arizona, United States
University of Arkansas for Medical Sciences /ID# 271290
Little Rock, Arkansas, United States
Retina Vitreous Assoc Med Grp /ID# 256299
Beverly Hills, California, United States
Retinal Diagnostic Center /ID# 256137
Campbell, California, United States
The Retina Partners - Encino /ID# 256054
Encino, California, United States
Retina Consultants of Orange County /ID# 256152
Fullerton, California, United States
Salehi Retina Institute /ID# 263485
Huntington Beach, California, United States
UC Irvine/Gavin Herbert Eye Institute /ID# 256145
Irvine, California, United States
Northern California Retina Vitreous Associates Medical Group, Inc /ID# 256298
Mountain View, California, United States
UCLA Doheny Eye Center /ID# 256120
Pasadena, California, United States
California Eye Specialists Medical Group Inc. /ID# 256079
Pasadena, California, United States
Retina Consultants of San Diego /ID# 256021
Poway, California, United States
Retinal Consultants Medical Group /ID# 256047
Sacramento, California, United States
West Coast Retina /ID# 256448
San Francisco, California, United States
University of California, San Francisco /ID# 256130
San Francisco, California, United States
Orange County Retina Medical Group /ID# 256073
Santa Ana, California, United States
California Retina Consultants - Santa Barbara /ID# 256017
Santa Barbara, California, United States
Retina Consultants of Southern Colorado /ID# 256069
Colorado Springs, Colorado, United States
Southwest Retina Research Center /ID# 256136
Durango, Colorado, United States
Colorado Retina Associates /ID# 256121
Lakewood, Colorado, United States
Retina Group of New England - Waterford /ID# 256071
Waterford, Connecticut, United States
Advanced Research, LLC /ID# 275451
Deerfield Beach, Florida, United States
Vitreoretinal Associates, P.A. /ID# 256150
Gainesville, Florida, United States
Florida Retina Consultants /ID# 265661
Lakeland, Florida, United States
Bascom Palmer Eye Institute - University of Miami /ID# 256072
Miami, Florida, United States
Retina Specialty Institute /ID# 256153
Pensacola, Florida, United States
Retina Vitreous Associates of Florida - St. Petersburg /ID# 256050
St. Petersburg, Florida, United States
Southern Vitreoretinal Associates /ID# 256158
Tallahassee, Florida, United States
Southeast Retina Center /ID# 256022
Augusta, Georgia, United States
Georgia Retina - Marietta /ID# 256142
Marietta, Georgia, United States
Marietta Eye Clinic /ID# 268163
Marietta, Georgia, United States
Thomas Eye Group PC /ID# 268159
Sandy Springs, Georgia, United States
Retina Consultants of Hawaii /ID# 256049
‘Aiea, Hawaii, United States
University of Illinois at Chicago /ID# 256300
Chicago, Illinois, United States
University Retina and Macula Associates /ID# 256078
Lemont, Illinois, United States
University Retina and Macula Associates /ID# 256077
Oak Forest, Illinois, United States
Springfield Clinic /ID# 266225
Springfield, Illinois, United States
Retina Partners Midwest, PC /ID# 256045
Indianapolis, Indiana, United States
John-Kenyon American Eye Institute -New Albany /ID# 256065
New Albany, Indiana, United States
Retina Associates - Lenexa /ID# 256080
Lenexa, Kansas, United States
Cincinnati Eye Institute- Edgewood /ID# 256132
Edgewood, Kentucky, United States
Retina Associates of New Orleans /ID# 272440
Metairie, Louisiana, United States
Ochsner Medical Center - Jefferson Highway /ID# 270524
New Orleans, Louisiana, United States
The Retina Care Center /ID# 256144
Baltimore, Maryland, United States
Johns Hopkins Hospital /ID# 256015
Baltimore, Maryland, United States
The Retina Group Of Washington - Chevy Chase /ID# 276039
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants - Hagerstown /ID# 256151
Hagerstown, Maryland, United States
Ophthalmic Consultants of Boston /ID# 256014
Boston, Massachusetts, United States
Retina Associates of Michigan /ID# 266198
Grand Blanc, Michigan, United States
Associated Retinal Consultants /ID# 256156
Royal Oak, Michigan, United States
VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256160
Edina, Minnesota, United States
Mayo Clinic - Minnesota /ID# 256051
Rochester, Minnesota, United States
The Retina Institute /ID# 266587
St Louis, Missouri, United States
Sierra Eye Associates /ID# 256020
Reno, Nevada, United States
Eye Associates of New Mexico /ID# 256075
Albuquerque, New Mexico, United States
Long Island Vitreoretinal Consultants /ID# 256074
Great Neck, New York, United States
Retina-Vitreous Surgeons of Central New York - Liverpool /ID# 266274
Liverpool, New York, United States
Duke Eye Center /ID# 256076
Durham, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 270767
Winston-Salem, North Carolina, United States
Retina Associates of Cleveland-Middleburg Heights /ID# 256052
Cleveland, Ohio, United States
Cleveland Clinic Main Campus /ID# 256064
Cleveland, Ohio, United States
Retina Vitreous Center, Research /ID# 256067
Edmond, Oklahoma, United States
Verum Research, LLC /ID# 266585
Eugene, Oregon, United States
Retina Northwest, PC /ID# 256140
Portland, Oregon, United States
Erie Retina Research /ID# 256154
Erie, Pennsylvania, United States
Retina Vitreous Consultants - Monroeville /ID# 271654
Monroeville, Pennsylvania, United States
Mid Atlantic Retina /ID# 256013
Philadelphia, Pennsylvania, United States
Charleston Neuroscience Institute /ID# 256235
Ladson, South Carolina, United States
Black Hills Regional Eye Institute /ID# 256161
Rapid City, South Dakota, United States
Charles Retina Institute /ID# 256016
Germantown, Tennessee, United States
Retina Research Institute of Texas /ID# 256141
Abilene, Texas, United States
Austin Research Center for Retina /ID# 256148
Austin, Texas, United States
Austin Retina Associates - Austin /ID# 256053
Austin, Texas, United States
Austin Clinical Research, LLC /ID# 256043
Austin, Texas, United States
Retina Consultants of Texas - Beaumont /ID# 266279
Beaumont, Texas, United States
Retina and Vitreous of Texas /ID# 263961
Bellaire, Texas, United States
Texas Retina Associates - Dallas /ID# 256133
Dallas, Texas, United States
Baylor Scott & White Surgicare /ID# 256122
Fort Worth, Texas, United States
Retina Consultants Of Texas /ID# 268611
San Antonio, Texas, United States
Stone Oak Surgery Center /ID# 266199
San Antonio, Texas, United States
Retina Center Of Texas (Rct) - Southlake /ID# 256056
Southlake, Texas, United States
Retina Consultants - The Woodlands /ID# 256018
The Woodlands, Texas, United States
Retina Associates of Utah /ID# 256044
Salt Lake City, Utah, United States
John A. Moran Eye Center /ID# 256068
Salt Lake City, Utah, United States
Wagner Macula & Retina Center - Norfolk /ID# 256134
Norfolk, Virginia, United States
Pacific Northwest Retina /ID# 256155
Bellevue, Washington, United States
Retina Center NW, PLLC /ID# 256157
Silverdale, Washington, United States
University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences /ID# 256159
Madison, Wisconsin, United States