Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
Public ClinicalTrials.gov record NCT04704921. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04704921
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 671 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years to 89 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 29, 2020 (Actual)
- Primary completion
- Dec 2026 (Estimated)
- Completion
- Nov 2027 (Estimated)
- Last update posted
- Apr 28, 2026
2020 – 2027
United States locations
- U.S. sites
- 89
- U.S. states
- 34
- U.S. cities
- 80
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Research Institute /ID# 256019 | Phoenix | Arizona | 85053 | — |
| Barnet Dulaney Perkins Eye Center - Sun City /ID# 256055 | Sun City | Arizona | 85351 | — |
| University of Arkansas for Medical Sciences /ID# 271290 | Little Rock | Arkansas | 72205 | — |
| Retina Vitreous Assoc Med Grp /ID# 256299 | Beverly Hills | California | 90211 | — |
| Retinal Diagnostic Center /ID# 256137 | Campbell | California | 95008 | — |
| The Retina Partners - Encino /ID# 256054 | Encino | California | 91436 | — |
| Retina Consultants of Orange County /ID# 256152 | Fullerton | California | 92835 | — |
| Salehi Retina Institute /ID# 263485 | Huntington Beach | California | 92647 | — |
| UC Irvine/Gavin Herbert Eye Institute /ID# 256145 | Irvine | California | 92697 | — |
| Northern California Retina Vitreous Associates Medical Group, Inc /ID# 256298 | Mountain View | California | 94040-4101 | — |
| UCLA Doheny Eye Center /ID# 256120 | Pasadena | California | 91105 | — |
| California Eye Specialists Medical Group Inc. /ID# 256079 | Pasadena | California | 91107 | — |
| Retina Consultants of San Diego /ID# 256021 | Poway | California | 92064-2530 | — |
| Retinal Consultants Medical Group /ID# 256047 | Sacramento | California | 95825 | — |
| West Coast Retina /ID# 256448 | San Francisco | California | 94107 | — |
| University of California, San Francisco /ID# 256130 | San Francisco | California | 94143 | — |
| Orange County Retina Medical Group /ID# 256073 | Santa Ana | California | 92705 | — |
| California Retina Consultants - Santa Barbara /ID# 256017 | Santa Barbara | California | 93103 | — |
| Retina Consultants of Southern Colorado /ID# 256069 | Colorado Springs | Colorado | 80909 | — |
| Southwest Retina Research Center /ID# 256136 | Durango | Colorado | 81303 | — |
| Colorado Retina Associates /ID# 256121 | Lakewood | Colorado | 80228 | — |
| Retina Group of New England - Waterford /ID# 256071 | Waterford | Connecticut | 06385-1215 | — |
| Advanced Research, LLC /ID# 275451 | Deerfield Beach | Florida | 33064-1342 | — |
| Vitreoretinal Associates, P.A. /ID# 256150 | Gainesville | Florida | 32607 | — |
| Florida Retina Consultants /ID# 265661 | Lakeland | Florida | 33805 | — |
| Bascom Palmer Eye Institute - University of Miami /ID# 256072 | Miami | Florida | 33136 | — |
| Retina Specialty Institute /ID# 256153 | Pensacola | Florida | 32503 | — |
| Retina Vitreous Associates of Florida - St. Petersburg /ID# 256050 | St. Petersburg | Florida | 33711-1141 | — |
| Southern Vitreoretinal Associates /ID# 256158 | Tallahassee | Florida | 32308 | — |
| Southeast Retina Center /ID# 256022 | Augusta | Georgia | 30909 | — |
| Georgia Retina - Marietta /ID# 256142 | Marietta | Georgia | 30060 | — |
| Marietta Eye Clinic /ID# 268163 | Marietta | Georgia | 30060 | — |
| Thomas Eye Group PC /ID# 268159 | Sandy Springs | Georgia | 30328-4411 | — |
| Retina Consultants of Hawaii /ID# 256049 | ‘Aiea | Hawaii | 96701 | — |
| University of Illinois at Chicago /ID# 256300 | Chicago | Illinois | 60607 | — |
| University Retina and Macula Associates /ID# 256078 | Lemont | Illinois | 60439 | — |
| University Retina and Macula Associates /ID# 256077 | Oak Forest | Illinois | 60452 | — |
| Springfield Clinic /ID# 266225 | Springfield | Illinois | 62702-3749 | — |
| Retina Partners Midwest, PC /ID# 256045 | Indianapolis | Indiana | 46290 | — |
| John-Kenyon American Eye Institute -New Albany /ID# 256065 | New Albany | Indiana | 47150-3620 | — |
| Retina Associates - Lenexa /ID# 256080 | Lenexa | Kansas | 66215 | — |
| Cincinnati Eye Institute- Edgewood /ID# 256132 | Edgewood | Kentucky | 41017-3415 | — |
| Retina Associates of New Orleans /ID# 272440 | Metairie | Louisiana | 70006-2940 | — |
| Ochsner Medical Center - Jefferson Highway /ID# 270524 | New Orleans | Louisiana | 70121 | — |
| The Retina Care Center /ID# 256144 | Baltimore | Maryland | 21209 | — |
| Johns Hopkins Hospital /ID# 256015 | Baltimore | Maryland | 21287 | — |
| The Retina Group Of Washington - Chevy Chase /ID# 276039 | Chevy Chase | Maryland | 20815 | — |
| Cumberland Valley Retina Consultants - Hagerstown /ID# 256151 | Hagerstown | Maryland | 21740 | — |
| Ophthalmic Consultants of Boston /ID# 256014 | Boston | Massachusetts | 02114 | — |
| Retina Associates of Michigan /ID# 266198 | Grand Blanc | Michigan | 48439 | — |
| Associated Retinal Consultants /ID# 256156 | Royal Oak | Michigan | 48073 | — |
| VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256160 | Edina | Minnesota | 55435 | — |
| Mayo Clinic - Minnesota /ID# 256051 | Rochester | Minnesota | 55905 | — |
| The Retina Institute /ID# 266587 | St Louis | Missouri | 46214 | — |
| Sierra Eye Associates /ID# 256020 | Reno | Nevada | 89502 | — |
| Eye Associates of New Mexico /ID# 256075 | Albuquerque | New Mexico | 87109 | — |
| Long Island Vitreoretinal Consultants /ID# 256074 | Great Neck | New York | 11021 | — |
| Retina-Vitreous Surgeons of Central New York - Liverpool /ID# 266274 | Liverpool | New York | 13088 | — |
| Duke Eye Center /ID# 256076 | Durham | North Carolina | 27705 | — |
| Atrium Health Wake Forest Baptist Medical Center /ID# 270767 | Winston-Salem | North Carolina | 27157 | — |
| Retina Associates of Cleveland-Middleburg Heights /ID# 256052 | Cleveland | Ohio | 44130 | — |
| Cleveland Clinic Main Campus /ID# 256064 | Cleveland | Ohio | 44195 | — |
| Retina Vitreous Center, Research /ID# 256067 | Edmond | Oklahoma | 73013 | — |
| Verum Research, LLC /ID# 266585 | Eugene | Oregon | 97401 | — |
| Retina Northwest, PC /ID# 256140 | Portland | Oregon | 97221 | — |
| Erie Retina Research /ID# 256154 | Erie | Pennsylvania | 16507 | — |
| Retina Vitreous Consultants - Monroeville /ID# 271654 | Monroeville | Pennsylvania | 15146 | — |
| Mid Atlantic Retina /ID# 256013 | Philadelphia | Pennsylvania | 19107 | — |
| Charleston Neuroscience Institute /ID# 256235 | Ladson | South Carolina | 29456 | — |
| Black Hills Regional Eye Institute /ID# 256161 | Rapid City | South Dakota | 57701 | — |
| Charles Retina Institute /ID# 256016 | Germantown | Tennessee | 38138 | — |
| Retina Research Institute of Texas /ID# 256141 | Abilene | Texas | 79606-1224 | — |
| Austin Research Center for Retina /ID# 256148 | Austin | Texas | 78705 | — |
| Austin Retina Associates - Austin /ID# 256053 | Austin | Texas | 78705 | — |
| Austin Clinical Research, LLC /ID# 256043 | Austin | Texas | 78750-2298 | — |
| Retina Consultants of Texas - Beaumont /ID# 266279 | Beaumont | Texas | 77707 | — |
| Retina and Vitreous of Texas /ID# 263961 | Bellaire | Texas | 77401 | — |
| Texas Retina Associates - Dallas /ID# 256133 | Dallas | Texas | 75231 | — |
| Baylor Scott & White Surgicare /ID# 256122 | Fort Worth | Texas | 76104 | — |
| Retina Consultants Of Texas /ID# 268611 | San Antonio | Texas | 78240 | — |
| Stone Oak Surgery Center /ID# 266199 | San Antonio | Texas | 78240 | — |
| Retina Center Of Texas (Rct) - Southlake /ID# 256056 | Southlake | Texas | 76092 | — |
| Retina Consultants - The Woodlands /ID# 256018 | The Woodlands | Texas | 77384 | — |
| Retina Associates of Utah /ID# 256044 | Salt Lake City | Utah | 84107 | — |
| John A. Moran Eye Center /ID# 256068 | Salt Lake City | Utah | 84132 | — |
| Wagner Macula & Retina Center - Norfolk /ID# 256134 | Norfolk | Virginia | 23502 | — |
| Pacific Northwest Retina /ID# 256155 | Bellevue | Washington | 98004 | — |
| Retina Center NW, PLLC /ID# 256157 | Silverdale | Washington | 98383 | — |
| University of Wisconsin-Madison, Department of Ophthalmology and Visual Sciences /ID# 256159 | Madison | Wisconsin | 53705-3644 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04704921, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 28, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04704921 live on ClinicalTrials.gov.