Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
Public ClinicalTrials.gov record NCT07007065. 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, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD). Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide. Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study identification
- NCT ID
- NCT07007065
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 561 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 50 Years and older
- 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
- Nov 4, 2025
- Primary completion
- Feb 28, 2033
- Completion
- Feb 28, 2033
- Last update posted
- Aug 13, 2026
2025 – 2033
United States locations
- U.S. sites
- 53
- U.S. states
- 20
- U.S. cities
- 52
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Barnet Dulaney Perkins Eye Centers /ID# 279265 | Mesa | Arizona | 85206 | Recruiting |
| American Vision Partners /ID# 264615 | Sun City | Arizona | 85351 | Recruiting |
| Retinal Diagnostic Center /ID# 263054 | Campbell | California | 95008 | Recruiting |
| The Retina Partners /ID# 263265 | Encino | California | 91436 | Recruiting |
| Retina Associates of Southern California /ID# 263056 | Huntington Beach | California | 92647 | Recruiting |
| Northern California Retina Vitreous Associates - Mountain View /ID# 263990 | Mountain View | California | 94040-4119 | Recruiting |
| Eye Research Foundation /ID# 277345 | Newport Beach | California | 92663 | Recruiting |
| Retina Consultants of San Diego /ID# 264026 | Poway | California | 92064-2530 | Recruiting |
| Retina Consultants Of Southern California - Redlands /ID# 276496 | Redlands | California | 92374 | Recruiting |
| Kaiser Permanente - Riverside Medical Center /ID# 263253 | Riverside | California | 92505 | Recruiting |
| Retinal Consultants - Sacramento - Greenback Lane /ID# 263983 | Sacramento | California | 95841 | Recruiting |
| UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058 | San Francisco | California | 94143-2510 | Recruiting |
| Orange County Retina Medical Group /ID# 266612 | Santa Ana | California | 92705 | Recruiting |
| Retina Consultants of Southern Colorado /ID# 263284 | Colorado Springs | Colorado | 80909 | Recruiting |
| Colorado Retina Associates /ID# 263247 | Lakewood | Colorado | 80228 | Recruiting |
| Advanced Vision Surgery Center /ID# 264208 | Longmont | Colorado | 80503 | Recruiting |
| Advanced Research, LLC /ID# 276526 | Deerfield Beach | Florida | 33064-1346 | Recruiting |
| Segal Drug Trials, Inc /ID# 276966 | Delray Beach | Florida | 33484 | Recruiting |
| Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631 | Fort Myers | Florida | 33917 | Recruiting |
| Leder Retina & Uveitis Specialist /ID# 276824 | Jacksonville | Florida | 32216 | Not yet recruiting |
| Florida Retina Institute - Lake Mary /ID# 263288 | Lake Mary | Florida | 32746 | Recruiting |
| Center for Retina and Macular Disease /ID# 264201 | Winter Haven | Florida | 33880 | Recruiting |
| Southeast Retina Center /ID# 263264 | Augusta | Georgia | 30909 | Recruiting |
| Vision Medical Research /ID# 277102 | Oak Lawn | Illinois | 60453 | Recruiting |
| Springfield Clinic Main Campus /ID# 265202 | Springfield | Illinois | 62703-2403 | Recruiting |
| Midwest Eye Institute North Indianapolis /ID# 264031 | Carmel | Indiana | 46290 | Recruiting |
| Wolfe Eye Clinic - West Des Moines /ID# 263270 | West Des Moines | Iowa | 50266 | Recruiting |
| Retina Associates - Lenexa /ID# 264607 | Lenexa | Kansas | 66215 | Recruiting |
| Maine Eye Center - Marginal Way Campus /ID# 263251 | Portland | Maine | 04101 | Recruiting |
| The Retina Care Center /ID# 263263 | Baltimore | Maryland | 21209 | Recruiting |
| Retina Specialist /ID# 264633 | Towson | Maryland | 21204 | Recruiting |
| Associated Retinal Consultants /ID# 263289 | Royal Oak | Michigan | 48073 | Recruiting |
| Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427 | Edina | Minnesota | 55435 | Recruiting |
| Mayo Clinic - Minnesota /ID# 263977 | Rochester | Minnesota | 55905 | Recruiting |
| Retina Institute - St. Louis /ID# 263985 | St Louis | Missouri | 63128 | Recruiting |
| Monmouth Retina Consultants /ID# 279252 | Little Silver | New Jersey | 07739 | Recruiting |
| Cleveland Clinic - Cleveland /ID# 264210 | Cleveland | Ohio | 44195 | Recruiting |
| Ohio State Havener Eye Institute - Columbus /ID# 263987 | Columbus | Ohio | 43212 | Recruiting |
| Midwest Retina /ID# 263231 | Dublin | Ohio | 43016 | Recruiting |
| Erie Retina Research /ID# 263287 | Erie | Pennsylvania | 16507 | Recruiting |
| Mid Atlantic Retina /ID# 263291 | Philadelphia | Pennsylvania | 19107 | Recruiting |
| Charleston Neuroscience Institute - Bluffton /ID# 264037 | Bluffton | South Carolina | 29910 | Recruiting |
| Charleston Neuroscience Institute - Charleston /ID# 276425 | Charleston | South Carolina | 29414 | Recruiting |
| Retina Consultants of South Carolina - Ladson /ID# 277596 | Ladson | South Carolina | 29456 | Recruiting |
| Retina Consultants of America /ID# 264038 | Mt. Pleasant | South Carolina | 29464 | Recruiting |
| Retina Research Institute of Texas /ID# 263233 | Abilene | Texas | 79606 | Recruiting |
| Austin Retina Associates - Austin /ID# 266770 | Austin | Texas | 78705 | Recruiting |
| Austin Clinical Research, LLC /ID# 263229 | Austin | Texas | 78750-2298 | Recruiting |
| Star Retina /ID# 266386 | Burleson | Texas | 76028 | Recruiting |
| Retina Consultants of Texas /ID# 263274 | Houston | Texas | 77056-3030 | Recruiting |
| Austin Retina Associates - Round Rock /ID# 266776 | Round Rock | Texas | 78681 | Recruiting |
| Retina Consultants of Texas - Westover /ID# 264209 | San Antonio | Texas | 78251 | Recruiting |
| Rocky Mountain Retina Consultants /ID# 263266 | Murray | Utah | 84107 | Recruiting |
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 78 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07007065, 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 13, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07007065 live on ClinicalTrials.gov.