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Study of Surabgene Lomparvovec Compared to Ranibizumab for Adults with Wet Age-Related Macular Degeneration

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with neovascular age-related macular degeneration, a condition where abnormal blood vessels grow under the central part of the retina at the back of the eye, which can lead to vision loss. The study will test a treatment called surabgene lomparvovec, also known as ABBV-RGX-314, which is a gene therapy given as a single injection under the retina. This treatment is designed to help the eye produce its own medicine that blocks the growth of abnormal blood vessels. The study will compare this gene therapy to ranibizumab, which is an approved medicine given as repeated injections into the eye to treat this condition.

The purpose of this study is to find out how many injections people need after receiving the gene therapy compared to those who continue getting regular injections of ranibizumab, and to see how well the gene therapy works in preserving vision over time in a setting that is similar to everyday medical practice. The study will also look at the safety of the gene therapy and measure any side effects that may occur in the treated eye or the other eye. Additionally, the study will check for changes in areas of damage in the central part of the retina.

People taking part in the study will be randomly assigned to receive either the gene therapy or ranibizumab. Those who receive the gene therapy will have it injected under the retina during a surgical procedure, while those in the comparison group will receive ranibizumab injections into the eye as needed based on how their condition responds. During the first year, people will be monitored closely and receive additional injections if needed according to specific guidelines. After the first year, the treatment schedule will follow a more flexible approach that reflects how treatment is typically managed in regular clinics. The study will last for several years to see how well vision is maintained over the long term.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    Upon joining the study, you will be randomly assigned to one of two treatment groups. One group will receive surabgene lomparvovec, which is delivered as a single injection beneath the retina in your eye. The other group will receive ranibizumab, which is given as injections into the eye as needed.

    The study eye is the eye that will receive treatment. If you have had cataract surgery, it must have been completed at least 12 weeks before starting the study.

  2. Step 2

    Treatment administration

    If you are assigned to receive surabgene lomparvovec, you will receive a single injection of this medication beneath the retina of your study eye. This is called subretinal administration. The medication is a suspension for injection.

    If you are assigned to receive ranibizumab, you will receive injections into the eye as needed based on specific criteria. This is called intravitreal administration. The medication is a solution for injection, available as Lucentis 10 mg/ml in a pre-filled syringe.

  3. Step 3

    First year monitoring period

    From week 6 through week 54 (the first year), you will be monitored regularly. During this time, the number of injections you receive will be tracked.

    If you are in the ranibizumab group, you will receive additional injections only when needed, based on specific protocol criteria determined during your visits.

    Your best corrected visual acuity (the clearest vision you can achieve with glasses or contact lenses) will be measured and compared to your vision at the start of the study.

  4. Step 4

    Extended monitoring through year three

    Monitoring will continue from week 6 through year 3. The total number of anti-VEGF injections you receive during this entire period will be recorded.

    Changes in your vision from the beginning of the study will be assessed at the year 3 time point.

    If you are in the ranibizumab group, after the first year, injections will be given as needed based on criteria that reflect typical clinical practice.

  5. Step 5

    Safety and eye health assessments

    Throughout the study, any eye-related side effects in both your study eye and your other eye will be recorded and evaluated for their severity.

    Your eyes will be examined using fundus autofluorescence (FAF), which is a special imaging technique that takes pictures of the back of your eye. This will measure any changes in areas of macular atrophy (thinning or damage to the central part of the retina) compared to the start of the study.

  6. Step 6

    Long-term follow-up

    The study will continue for several years to assess the long-term preservation of your visual acuity and the overall safety of the treatment.

    Regular visits will be scheduled to monitor your eye health and vision over this extended period.

Who can join the trial?

6 criteria

  • You must have had cataract surgery (a procedure to replace the cloudy lens in your eye with a clear artificial lens) at least 12 weeks before the first screening visit in the eye being studied
  • You must have a diagnosis of CNV (choroidal neovascularization, which means abnormal new blood vessels growing under the retina at the back of your eye) caused by AMD (age-related macular degeneration, a condition affecting the central part of your vision) in the eye being studied
  • You must have received at least 2 intravitreal anti-VEGF injections (eye injections with medicine that stops abnormal blood vessel growth) in the past 6 months in the eye being studied before the first screening visit
  • Your eye must have responded well to the previous anti-VEGF injections, as determined by your doctor
  • You can be male or female
  • You must be an adult or elderly person

Who cannot join the trial?

7 criteria

  • The specific exclusion criteria (reasons why a patient cannot participate in this study) have not been provided in the available information
  • Generally, clinical trials have rules about who can and cannot join to ensure patient safety and reliable results
  • Common reasons patients might not be able to join eye treatment studies may include having other serious eye diseases, recent eye surgery, active eye infections, or certain general health conditions
  • Pregnant or breastfeeding women are often excluded from studies involving new treatments
  • People taking certain medications that might interfere with the study treatment may not be eligible
  • Patients with known allergies (bad reactions) to similar medications used in the study may be excluded
  • Those who have participated in other clinical trials recently might not be allowed to join
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Investigated drugs

  • Surabgene lomparvovec

    is a gene therapy that is given as a one-time injection under the retina (the light-sensitive tissue at the back of the eye). It works by delivering genetic material that helps your eye produce its own medicine to treat wet age-related macular degeneration, a condition where abnormal blood vessels grow in the eye and can cause vision loss.

  • Ranibizumab

    is a medicine that is injected into the eye to treat wet age-related macular degeneration. It works by blocking a protein that causes abnormal blood vessel growth in the eye. This medication helps reduce swelling and leaking from these blood vessels, which can help preserve or improve vision.

What is already known about the treatment

  • Surabgene Lomparvovec

    Surabgene Lomparvovec is an experimental gene therapy medication currently being tested in Phase 3b clinical trials for the treatment of neovascular age-related macular degeneration, a condition where abnormal blood vessels grow in the eye and can cause vision loss. This medication is administered as a one-time injection beneath the retina (the light-sensitive layer at the back of the eye) during a surgical procedure. It works at the molecular level by delivering genetic material that instructs eye cells to produce their own anti-VEGF protein, which blocks the growth of abnormal blood vessels that damage vision, potentially reducing the need for frequent eye injections over time.

  • Ranibizumab

    Ranibizumab is an approved medication used to treat neovascular age-related macular degeneration and other eye conditions involving abnormal blood vessel growth. It is administered as an injection directly into the vitreous (the gel-like substance inside the eye) and is typically given on a regular or as-needed basis in a doctor's office. This medication works by blocking a protein called VEGF (vascular endothelial growth factor) that promotes the growth of abnormal blood vessels in the eye, thereby helping to prevent further vision loss and, in some cases, improving vision.

Investigated diseases

Neovascular Age-Related Macular Degeneration – This is an eye disease that affects the macula, which is the central part of the retina responsible for sharp, detailed vision. The condition occurs when abnormal blood vessels grow beneath the retina and leak fluid or blood, damaging the macula. As the disease progresses, it causes distortion of straight lines and blurring of central vision, making activities like reading and recognizing faces difficult. The leaking fluid can lead to swelling and scarring of the macula over time. This form of age-related macular degeneration develops more rapidly than the dry form. It primarily affects people over the age of 50 and can significantly impact daily activities requiring clear central vision.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512298-28-00Protocol codeM24-528Estimated enrolment561 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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