At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Surabgene Lomparvovec (ABBV-RGX-314) (drug), Ranibizumab Control (drug)
- How long the study runs
- Study runs about 88 months (dates as stated)
- About the drug or intervention
- Surabgene Lomparvovec (ABBV-RGX-314) — drug: subretinal injection · Ranibizumab Control — drug: intravitreal injection
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 50 Years and over
- Who
- All
- Number of participants
- 561
- Started
- 2025-11-05
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for neovascular age-related macular degeneration
- • Phase3 - 561 participants
- • 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
Who can take part?
- • Ages 50 Years and over
- • Diagnosed with neovascular age-related macular degeneration
Where?
- • Gloucester - Gloucestershire Royal Hospital /ID# 276072
- • London - Moorfields Eye Hospital /ID# 267227
- • London - The Retina Clinic London /ID# 266156
- • Liverpool - Liverpool University Hospitals NHS Foundation Trust /ID# 265854
- • +3 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years and over
- Who can join: All genders
What the study is looking for
- ✓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...
- ✓-CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc...
Who cannot take part
- ✗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...
- ✗Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the...
See the full criteria
Where Is This Study? (7 UK sites)
Gloucestershire Royal Hospital /ID# 276072
Gloucester GL1 3NN, United Kingdom
R&I Professional Services
ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467Moorfields Eye Hospital /ID# 267227
London EC1V 2PD, United Kingdom
Research Portfolio Managers- Daniela Narvaez, Anika Kadchha, Abi Chandrakumar, Xin Liu
moorfields.resadmin@nhs.net0207 566 2036The Retina Clinic London /ID# 266156
London W1G 7LB, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 265854
Liverpool L9 7AL, United Kingdom
Bristol Eye Hospital /ID# 266155
Bristol BS1 2LX, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 267024
Newcastle upon Tyne NE3 3HD, United Kingdom
Sunderland Royal Hospital /ID# 266664
Sunderland SR4 7TN, United Kingdom
How to Get in Touch
ABBVIE CALL CENTER
Sponsor contactCONTACT