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RECRUITING 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)

NCT07007065 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 561 participants
Start Date 2025-11-05
Est. Completion 2033-03
Phase Phase 3

Sponsor

AbbVie

603 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07007065

The ClinicalTrials.gov registry entry for NCT07007065 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 561 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07007065 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07007065?

The interventions under investigation include: Surabgene Lomparvovec (ABBV-RGX-314) (DRUG), Ranibizumab Control (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07007065?

This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial