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Study on the Effects of RGX-314 Gene Therapy Compared to Aflibercept and Ranibizumab for Patients with Neovascular 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 clinical trial is focused on studying a condition called neovascular age-related macular degeneration (nAMD), which affects the eyes and can lead to vision loss. The study is testing a new treatment called RGX-314, which is a type of gene therapy. Gene therapy involves using genes to treat or prevent diseases. In this case, RGX-314 is designed to help manage nAMD by targeting a specific protein involved in the disease process. The study will compare the effectiveness and safety of RGX-314 with another treatment called aflibercept, which is already used to treat nAMD. Aflibercept is given as an injection into the eye to help reduce vision loss.

The purpose of the study is to see if RGX-314 is not worse than aflibercept in improving vision over a period of time. Participants in the study will receive either RGX-314 or aflibercept, and some may receive a placebo. The study will last for about 54 weeks, during which participants will have regular check-ups to monitor their vision and overall health. The study aims to find out if RGX-314 can help maintain or improve vision in people with nAMD, and if it can reduce the need for additional treatments.

Throughout the study, participants will undergo various assessments to track changes in their vision and any side effects they might experience. The study will also look at how often participants need additional treatments to manage their condition. By the end of the study, researchers hope to gather enough information to determine if RGX-314 is a safe and effective treatment option for people with neovascular age-related macular degeneration.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, vision score, and previous treatment response.

    Participants must be between 50 and 89 years old and have a specific vision score in the study eye.

    A diagnosis of neovascular age-related macular degeneration (nAMD) is required, with prior treatment history.

  2. Step 2

    Initial treatment phase

    Participants receive either aflibercept or RGX-314 as part of the treatment.

    Aflibercept is administered as an intravitreal injection, which means it is injected into the eye.

    RGX-314 is administered as a subretinal injection, which involves delivering the treatment beneath the retina.

  3. Step 3

    Treatment monitoring

    Participants are monitored for changes in vision and any side effects.

    The primary goal is to assess the change in vision from the start of the study to Week 54.

    The study also evaluates the need for additional anti-VEGF injections during this period.

  4. Step 4

    Follow-up assessments

    Regular follow-up visits are scheduled to assess vision and overall eye health.

    The effectiveness of RGX-314 compared to aflibercept is evaluated based on vision improvement and injection frequency.

  5. Step 5

    Completion of study

    The study concludes with a final assessment of vision and any long-term effects of the treatment.

    Participants' data contribute to understanding the safety and efficacy of RGX-314 for treating nAMD.

Who can join the trial?

6 criteria

  • Age must be between 50 and 89 years old.
  • Must have a specific vision score in the study eye, which is measured using a special eye chart called ETDRS BCVA. The score should be between 40 and 78 letters.
  • Must have a diagnosis of **CNV** (a type of eye condition) caused by **AMD** (age-related macular degeneration) in the study eye. The patient should have received at least one injection of a treatment called anti-VEGF in the study eye before the first screening visit and shown improvement.
  • Must have had cataract surgery in the study eye at least 12 weeks ago, meaning the eye is now **pseudophakic** (has an artificial lens).
  • Must be willing and able to sign a consent form to participate in the study and must not be in prison. People who are under legal protection or unable to give consent cannot participate.
  • Must have shown a meaningful improvement with anti-VEGF therapy at the start of the study.

Who cannot join the trial?

8 criteria

  • Patients who have any other eye diseases that could affect vision.
  • Patients who have had eye surgery within the last 3 months.
  • Patients who have received any other treatment for eye conditions within the last 3 months.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of stroke or heart attack within the last 6 months.
  • Patients with any other serious medical conditions that could interfere with the study.
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Investigated drugs

  • ABBV-RGX-314

    is a gene therapy being studied for its potential to treat neovascular age-related macular degeneration (nAMD). This therapy aims to provide a long-term solution by delivering a gene that helps the eye produce a protein to reduce abnormal blood vessel growth and leakage, which are common in nAMD.

  • Aflibercept

    is a medication used to treat nAMD by blocking the growth of abnormal blood vessels in the eye. It works by inhibiting specific proteins that contribute to the disease, helping to maintain or improve vision.

What is already known about the treatment

  • ABBV-RGX-314

    This medication is administered as a gene therapy injection directly into the eye. It is currently being studied in clinical trials for its effectiveness and safety in treating neovascular age-related macular degeneration (nAMD). The main therapeutic indication is to improve vision in patients with this condition. At the molecular level, it works by delivering a gene that produces a protein to inhibit the growth of abnormal blood vessels in the eye. It is classified as a gene therapy product.

  • Aflibercept

    This medication is administered through an injection into the eye. It is an established treatment in medical literature for neovascular age-related macular degeneration (nAMD). The main therapeutic indication is to prevent vision loss in patients with this condition. Its mechanism of action involves binding to and inhibiting proteins that promote the growth of abnormal blood vessels in the eye. It is classified as an anti-VEGF (vascular endothelial growth factor) agent.

Investigated diseases

Neovascular age-related macular degeneration – This is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp vision. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause the macula to lift and pull away from its base, resulting in rapid and severe vision loss. The disease typically progresses with symptoms such as blurred vision, dark spots in the center of vision, and distorted vision. Over time, it can lead to significant impairment in the ability to see fine details, affecting daily activities like reading and recognizing faces. The progression can vary, with some individuals experiencing a slow decline in vision, while others may notice a more rapid deterioration.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503666-23-00Protocol codeRGX-314-3101/M23-409Estimated enrolment714 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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