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Surabgene Lomparvovec to reduce injections and preserve vision in adults with wet AMD

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)

Phase 3 Interventional AbbVie · NCT07007065

This study will test whether a single subretinal dose of Surabgene Lomparvovec can reduce the need for repeated eye injections and help preserve vision in adults 50 and older with previously treated neovascular (wet) AMD compared with standard ranibizumab care.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment561 (estimated)
Ages50 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Drugs / interventionsRanibizumab
Locations104 sites (Mesa, Arizona and 103 other locations)
Trial IDNCT07007065 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial randomizes about 561 adults with previously treated neovascular AMD into three treatment arms: two arms receive a single subretinal dose of ABBV‑RGX‑314 (Surabgene Lomparvovec) and the control arm receives ranibizumab as needed. Eligible participants are pseudophakic adults aged 50 or older with CNV secondary to AMD and prior responsiveness to anti-VEGF injections. Key outcomes include injection burden, adverse events, changes in disease activity, and long-term maintenance of visual acuity, with centralized imaging review of lesion characteristics. The study is conducted across roughly 150 sites worldwide, including multiple retinal specialty centers in the United States.

Who should consider this trial

Good fit: Ideal candidates are adults aged 50 or older who are pseudophakic in the study eye, have CNV from AMD that is under 10 disc areas, and have received and responded to at least two anti-VEGF injections in the prior six months.

Not a fit: Patients with CNV or macular edema from causes other than AMD, nAMD diagnosed more than four years ago in the study eye, very large pigment epithelial detachments, recent cataract surgery, or those who have not responded to prior anti-VEGF therapy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the therapy could significantly reduce how often patients need intravitreal injections while helping maintain vision over the long term.

How similar studies have performed: Earlier-phase studies of RGX‑314/ABBV‑RGX‑314 have shown promising safety and reductions in injection requirements, but long-term Phase 3 evidence is still needed.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \[Week -6\]) in the study eye.
* Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye

  --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\^2)
* Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator)

Exclusion Criteria:

* CNV or macular edema in the study eye that is secondary to any causes other than AMD
* Study eye with nAMD diagnosed \> 4 years from Screening Visit 1
* Any retinal pigment epithelial detachment \> 400 μm or any pigment epithelial detachment \> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center.
* Any subretinal hemorrhage in the study eye \> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center
* Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.

Where this trial is running

Mesa, Arizona and 103 other locations

+54 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neovascular Age-related Macular DegenerationNeovascular age-related macular degenerationSurabgene LomparvovecABBV-RGX-314
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.