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Study to Assess the Injection Burden, Safety, Efficacy, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) Compared to Ranibizumab in Adult Participants with Neovascular Age-Related Macular Degeneration (nAMD)
EU CTIS ID: 2024-512298-28-00
What this study is testing
To evaluate anti-VEGF injection burden and long-term efficacy after subretinal surabgene lomparvovec administration, compared to PRN intravitreal ranibizumab given per protocol specified criteria during Year 1, and subsequently compared to a PRN intravitreal ranibizumab schedule that mimics the real-world clinic setting after Year 1.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 [Week –6]) in the study eye
- Must have a diagnosis of CNV secondary to AMD in the study eye
- Must have received at least 2 intravitreal anti-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)
You likely can't join if
- 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 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.
- History of retinal detachment, retinal tear or macular hole in the study eye that, in the opinion of the investigator, may preclude successful subretinal injection of surabgene lomparvovec.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Canada
- Puerto Rico
- Switzerland
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Canada; Puerto Rico; Switzerland; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.