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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Barnet Dulaney Perkins Eye Center - Mesa /ID# 279265
  Mesa, Arizona, United States Recruiting
• American Vision Partners /ID# 264615
  Sun City, Arizona, United States Recruiting
• Retinal Diagnostic Center /ID# 263054
  Campbell, California, United States Recruiting
• The Retina Partners /ID# 263265
  Encino, California, United States Recruiting
• Retina Associates of Southern California /ID# 263056
  Huntington Beach, California, United States Recruiting
• Shiley Eye Institute At Uc San Diego Health /ID# 276682
  La Jolla, California, United States Recruiting

+88 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.