Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
Public ClinicalTrials.gov record NCT05407636. 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 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05407636
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 735 participants
Conditions and interventions
Interventions
- ABBV-RGX-314 Dose 1 Genetic
- ABBV-RGX-314 Dose 2 Genetic
- Aflibercept (EYLEA®) Biological
Genetic · Biological
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
- Jan 13, 2022 (Actual)
- Primary completion
- Oct 2026 (Estimated)
- Completion
- Nov 2027 (Estimated)
- Last update posted
- Aug 3, 2026
2022 – 2027
United States locations
- U.S. sites
- 107
- U.S. states
- 33
- U.S. cities
- 97
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barnet Dulaney Eye Center-Phoenix /ID# 256340 | Phoenix | Arizona | 85016 | — |
| Retinal Research Institute /ID# 256238 | Phoenix | Arizona | 85053 | — |
| Retina Macula Institute of Arizona /ID# 271026 | Scottsdale | Arizona | 85255-4134 | — |
| California Retina Consultants - Bakersfield /ID# 256240 | Bakersfield | California | 93309-1677 | — |
| Retina Vitreous Assoc Med Grp /ID# 256246 | Beverly Hills | California | 90211 | — |
| Retinal Diagnostic Center /ID# 256262 | Campbell | California | 95008 | — |
| The Retina Partners - Encino /ID# 259660 | Encino | California | 91436 | — |
| Retina Consultants of Orange County /ID# 256267 | Fullerton | California | 92835 | — |
| Jacobs Retina Center at UCSD/ID# 256320 | La Jolla | California | 92093 | — |
| California Retina Consultants - Oxnard - North Ventura Road /ID# 262883 | Oxnard | California | 93036 | — |
| Byers Eye Institute Stanford /ID# 262853 | Palo Alto | California | 94303 | — |
| Retina Consultants of San Diego /ID# 256258 | Poway | California | 92064-2530 | — |
| Kaiser Permanente - Riverside Medical Center /ID# 262413 | Riverside | California | 92505 | — |
| UC Davis Health Eye Center | Sacramento | California | 95817 | — |
| Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353 | Sacramento | California | 95841 | — |
| Orange County Retina Medical Group /ID# 256286 | Santa Ana | California | 92705 | — |
| Macula Retina Vitreous Center - Torrance /ID# 270247 | Torrance | California | 90503 | — |
| Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513 | Walnut Creek | California | 94598 | — |
| Retina Consultants of Southern Colorado /ID# 256285 | Colorado Springs | Colorado | 80909 | — |
| Southwest Retina Research Center /ID# 256261 | Durango | Colorado | 81303 | — |
| Colorado Retina Associates /ID# 256378 | Lakewood | Colorado | 80228 | — |
| Advanced Vision Research Institute /ID# 256380 | Longmont | Colorado | 80503 | — |
| Retina Consultants, P.C. /ID# 273610 | Manchester | Connecticut | 06042-3556 | — |
| Rand Eye Institute /ID# 256337 | Deerfield Beach | Florida | 33064 | — |
| National Ophthalmic Research Institute /ID# 256344 | Fort Myers | Florida | 33912-7125 | — |
| Vitreoretinal Associates, P.A. /ID# 256266 | Gainesville | Florida | 32607 | — |
| Florida Retina Consultants /ID# 256321 | Lakeland | Florida | 33805 | — |
| Florida Retina Institute - Orlando /ID# 256373 | Orlando | Florida | 32806-1101 | — |
| Retina Specialty Institute /ID# 256268 | Pensacola | Florida | 32503 | — |
| Fort Lauderdale Eye Institute /ID# 266011 | Plantation | Florida | 33324 | — |
| Retina Vitreous Associates of Florida - St. Petersburg /ID# 256279 | St. Petersburg | Florida | 33711-1141 | — |
| Center for Retina and Macular Disease /ID# 256335 | Winter Haven | Florida | 33880 | — |
| Georgia Retina - Marietta /ID# 256264 | Marietta | Georgia | 30060 | — |
| Retina Consultants of Hawaii /ID# 256278 | ‘Aiea | Hawaii | 96701 | — |
| Northwestern Memorial Hospital - Department of Ophthalmology /ID# 256379 | Chicago | Illinois | 60611-2987 | — |
| University Retina and Macula Associates /ID# 256288 | Lemont | Illinois | 60439 | — |
| University Retina and Macula Associates /ID# 256287 | Oak Forest | Illinois | 60452 | — |
| Illinois Retina Associates - Oak Park /ID# 256375 | Oak Park | Illinois | 60304 | — |
| Springfield Clinic - First /ID# 256371 | Springfield | Illinois | 62702 | — |
| Retina Partners Midwest, PC /ID# 256277 | Indianapolis | Indiana | 46290 | — |
| John-Kenyon American Eye Institute -New Albany /ID# 256283 | New Albany | Indiana | 47150 | — |
| Wolfe Eye Clinic - West Des Moines /ID# 256314 | West Des Moines | Iowa | 50266 | — |
| Retina Associates - Lenexa /ID# 258296 | Lenexa | Kansas | 66215 | — |
| Maine Eye Center - Marginal Way Campus /ID# 256391 | Portland | Maine | 04101 | — |
| Retina Specialists /ID# 256392 | Baltimore | Maryland | 21204 | — |
| Johns Hopkins Hospital /ID# 256236 | Baltimore | Maryland | 21287 | — |
| Mid Atlantic Retina Specialists - Hagerstown /ID# 256310 | Hagerstown | Maryland | 21740-5965 | — |
| MA Eye & Ear Infirmary /ID# 262430 | Boston | Massachusetts | 02114 | — |
| Ophthalmic Consultants of Boston /ID# 256233 | Boston | Massachusetts | 02114 | — |
| Vitreo Retinal Associates - Worcester /ID# 266008 | Worcester | Massachusetts | 01605 | — |
| Retina Associates of Michigan /ID# 256393 | Grand Blanc | Michigan | 48439 | — |
| Associated Retinal Consultants /ID# 256269 | Royal Oak | Michigan | 48073 | — |
| VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256272 | Edina | Minnesota | 55435 | — |
| Mayo Clinic - Rochester /ID# 258295 | Rochester | Minnesota | 55905-0001 | — |
| Mississippi Retina Associates /ID# 270934 | Madison | Mississippi | 39110-2028 | — |
| Mid America Surgery Center /ID# 258993 | Chesterfield | Missouri | 63017 | — |
| University of Missouri Hospital /ID# 262474 | Columbia | Missouri | 65212 | — |
| Washington University School of Medicine - St. Louis /ID# 256383 | St Louis | Missouri | 63108 | — |
| Sierra Eye Associates /ID# 256239 | Reno | Nevada | 89502 | — |
| Envision Ocular, LLC /ID# 256367 | Bloomfield | New Jersey | 07003 | — |
| Monmouth Retina Consultants /ID# 275895 | Little Silver | New Jersey | 07739 | — |
| Columbia University of New York - Edward S. Harkness Eye Institute /ID# 256342 | New York | New York | 10032 | — |
| Retina Associates of Western New York /ID# 256374 | Rochester | New York | 14620 | — |
| Asheville Eye Associates- Retina Division /ID# 256355 | Asheville | North Carolina | 28803 | — |
| Duke University Medical Center /ID# 256245 | Durham | North Carolina | 27710 | — |
| Graystone Eye /ID# 256424 | Hickory | North Carolina | 28602 | — |
| Cincinnati Eye Institute /ID# 256247 | Cincinnati | Ohio | 45242-5664 | — |
| Retina Associates of Cleveland-Middleburg Heights /ID# 256280 | Cleveland | Ohio | 44130 | — |
| Cleveland Clinic - Cleveland /ID# 256282 | Cleveland | Ohio | 44195 | — |
| Ohio State University /ID# 256275 | Columbus | Ohio | 43210 | — |
| Midwest Retina /ID# 276644 | Dublin | Ohio | 43016 | — |
| Retina Vitreous Center, Research /ID# 256284 | Edmond | Oklahoma | 73013 | — |
| University of Pennsylvania /ID# 258995 | Philadelphia | Pennsylvania | 19104-5502 | — |
| Mid Atlantic Retina /ID# 256232 | Philadelphia | Pennsylvania | 19107 | — |
| University of Pittsburgh Medical Center /ID# 258994 | Pittsburgh | Pennsylvania | 15213 | — |
| Charleston Neuroscience Institute - Beaufort /ID# 256385 | Beaufort | South Carolina | 29902-6216 | — |
| Charleston Neurosciences Institute /ID# 256351 | Charleston | South Carolina | 29414-5896 | — |
| Palmetto Retina Center-Florence /ID# 256244 | Florence | South Carolina | 29501 | — |
| Charleston Neurosciences Institute /ID# 256336 | Ladson | South Carolina | 29414-5896 | — |
| Black Hills Regional Eye Institute /ID# 262872 | Rapid City | South Dakota | 57701 | — |
| Southeastern Retina Associates - Chattanooga /ID# 258992 | Chattanooga | Tennessee | 37421 | — |
| Charles Retina Institute /ID# 256237 | Germantown | Tennessee | 38138 | — |
| Southeastern Retina Associates - Johnson City /ID# 256396 | Johnson City | Tennessee | 37604 | — |
| Tennessee Retina - Nashville /ID# 256388 | Nashville | Tennessee | 37203-1513 | — |
| Vanderbilt University Medical Center /ID# 256372 | Nashville | Tennessee | 37232-0011 | — |
| Retina Research Institute of Texas /ID# 256263 | Abilene | Texas | 79606-1224 | — |
| Austin Research Center for Retina /ID# 256265 | Austin | Texas | 78705 | — |
| Austin Clinical Research, LLC /ID# 256274 | Austin | Texas | 78750-2298 | — |
| Retina Consultants of Texas - Bellaire /ID# 256377 | Bellaire | Texas | 77401 | — |
| Star Retina - Burleson /ID# 256376 | Burleson | Texas | 76028 | — |
| Texas Retina Associates /ID# 256259 | Dallas | Texas | 75231 | — |
| Texas Retina Associates - Fort Worth /ID# 256326 | Fort Worth | Texas | 76104 | — |
| Austin Retina Associates - Round Rock /ID# 256387 | Round Rock | Texas | 78681 | — |
| Retina Consultants of Texas/ID# 259661 | San Antonio | Texas | 78240-1655 | — |
| Retina Associates of South Texas | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas /ID# 256382 | San Antonio | Texas | 78251 | — |
| Retina Center Of Texas (Rct) - Southlake /ID# 256281 | Southlake | Texas | 76092 | — |
| Rocky Mountain Retina Consultants /ID# 256369 | Murray | Utah | 84107 | — |
| Retina Associates of Utah /ID# 256276 | Salt Lake City | Utah | 84107 | — |
| Piedmont Eye Center /ID# 256386 | Lynchburg | Virginia | 24502 | — |
| Wagner Kapoor Research Institute - Norfolk /ID# 256260 | Norfolk | Virginia | 23502 | — |
| Retina Institute of Virginia /ID# 256394 | Richmond | Virginia | 23235 | — |
| Vistar Eye Center /ID# 271024 | Roanoke | Virginia | 24019 | — |
| Pacific Northwest Retina /ID# 258999 | Bellevue | Washington | 98004 | — |
| Retina Center NW, PLLC /ID# 256395 | Silverdale | Washington | 98383 | — |
| Spokane Eye Clinic /ID# 256338 | Spokane | Washington | 99204 | — |
| Gundersen Health System - La Crosse Medical Center /ID# 276012 | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05407636, 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 Aug 3, 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 NCT05407636 live on ClinicalTrials.gov.