Neovascular Age-related Macular Degeneration study: Surabgene Lomparvovec
Official title 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)
ClinicalTrials.gov ID: NCT07007065
What this study is testing
What is Surabgene Lomparvovec (ABBV-RGX-314)?
This is an investigational gene therapy being studied as a potential treatment for neovascular age-related macular degeneration (nAMD).
Also referred to as ABBV-RGX-314.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if a new gene therapy is safe and effective for treating wet age-related macular degeneration. It also looks at how often injections are needed and how well vision is preserved over time.
- Who it's for
- The study is looking for adults aged 50 and older who have already been treated for wet age-related macular degeneration.
- What's involved
- Participants will receive either a one-time gene therapy injection behind the retina or standard anti-vein injections as needed. They will also undergo regular medical checks, blood tests, and vision assessments.
- Time commitment
- The study lasts up to 5 years and requires regular monthly visits to a hospital or clinic.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
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 choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye --CNV lesion...
- 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...
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 retinal pigment epithelial detachment \> 400 μm or any pigment epithelial detachment \> 350 μm within the central subfield (central 1 mm) in the...
- 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...
- Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.
The study team makes the final eligibility decision.
Where it is enrolling
- Mesa, Arizona, United States
- Sun City, Arizona, United States
- Campbell, California, United States
- Encino, California, United States
- Huntington Beach, California, United States
- La Jolla, California, United States
- Mountain View, California, United States
- Newport Beach, California, United States
- Poway, California, United States
- Redlands, California, United States
- Riverside, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Ana, California, United States
- Colorado Springs, Colorado, United States
- Lakewood, Colorado, United States
- Longmont, Colorado, United States
- Deerfield Beach, Florida, United States
- Delray Beach, Florida, United States
- Fort Myers, Florida, United States
+ 112 more site(s).
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, but 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, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Mesa, Arizona, United States; Sun City, Arizona, United States; Campbell, California, United States; Encino, California, United States; Huntington Beach, California, United States; La Jolla, California, United States and 126 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.