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NCT07007065 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Neovascular Age-related Macular Degeneration, sponsored by AbbVie.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 561
- Enrollment target
- 20
- Study locations
NCT07007065: Recruiting Phase 3 study of Neovascular Age-related Macular Degeneration, sponsored by AbbVie.
NCT07007065 is a Phase 3 study of Neovascular Age-related Macular Degeneration that is actively recruiting participants, run by AbbVie. The registered enrollment target is 561 participants, above the 392-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (43% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07007065, a Phase 3 study of Neovascular Age-related Macular Degeneration, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 561 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
To assess the injection burden and the necessity for supplemental anti-VEGF injections over the first year of the study period across the different treatment groups.
Conditions Studied
Interventions
- DRUG Surabgene Lomparvovec (ABBV-RGX-314)
- DRUG Ranibizumab Control
Study Locations (20)
California
- Retinal Diagnostic Center /ID# 263054 - Campbell
- The Retina Partners /ID# 263265 - Encino
- Retina Associates of Southern California /ID# 263056 - Huntington Beach
- Retinal Consultants - Sacramento - Greenback Lane /ID# 263983 - Sacramento
- Orange County Retina Medical Group /ID# 266612 - Santa Ana
Colorado
- Retina Consultants of Southern Colorado /ID# 263284 - Colorado Springs
- Colorado Retina Associates /ID# 263247 - Lakewood
- Advanced Vision Surgery Center /ID# 264208 - Longmont
Florida
- Advanced Research, LLC /ID# 276526 - Deerfield Beach
- Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631 - Fort Myers
- Florida Retina Institute - Lake Mary /ID# 263288 - Lake Mary
Maryland
- The Retina Care Center /ID# 263263 - Baltimore
- Retina Specialist /ID# 264633 - Towson
Arizona
- American Vision Partners /ID# 264615 - Sun City
Georgia
- Southeast Retina Center /ID# 263264 - Augusta
Illinois
- Springfield Clinic Main Campus /ID# 265202 - Springfield
Indiana
- Midwest Eye Institute North Indianapolis /ID# 264031 - Carmel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 561 participants |
| Start Date | 2025-11-05 |
| Est. Completion | 2033-03 |
| Phase | Phase 3 |
What NCT07007065 shows while recruiting
NCT07007065 is an interventional study that assigns participants to a tested intervention. The registered 561 participants enrollment target is mid-sized for trials with a published cap, above the 392-participant average among 33 other Neovascular Age-related Macular Degeneration trials with a reported enrollment target (43% higher).
The record links to 1 condition, with Neovascular Age-related Macular Degeneration appearing as the primary indexed condition, and to 2 interventions - of which Surabgene Lomparvovec (ABBV-RGX-314) is the first listed.
NCT07007065 names 20 study sites across 11 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT07007065 about?
NCT07007065 is a clinical study titled "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)". 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 partici...
What is the current status of trial NCT07007065?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 561 participants. The study started on 2025-11-05. Estimated completion is 2033-03.
What conditions does trial NCT07007065 study?
This clinical trial studies the following conditions: Neovascular Age-related Macular Degeneration.
What interventions are being tested in trial NCT07007065?
The interventions under investigation include: Surabgene Lomparvovec (ABBV-RGX-314) (DRUG), Ranibizumab Control (DRUG).
Who is sponsoring clinical trial NCT07007065?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07007065 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neovascular Age-related Macular Degeneration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07007065's enrollment target sits among peer trials
561 7th of 33 higher than 27 of 33 other Neovascular Age-related Macular Degeneration trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neovascular Age-related Macular Degeneration trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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