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A study comparing 4D-150 and aflibercept for adults with abnormal blood vessel growth in the eye due to 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 is looking at macular neovascularization secondary to age-related macular degeneration, which is a condition where abnormal blood vessels grow under the center part of the retina, the light-sensitive tissue at the back of the eye. This happens as part of age-related macular degeneration, a disease that affects central vision and is common in older adults. The study will test a treatment called 4D-150, which is an experimental gene therapy given as a single injection into the eye. This will be compared with aflibercept, an approved medication that is also injected into the eye but needs to be given repeatedly every eight weeks. The study will also use difluprednate eye drops as an additional medication. The purpose of the study is to find out if a single injection of the experimental treatment works as well as regular injections of the approved medication in maintaining or improving vision over time.

People taking part in the study will be randomly assigned to receive either one injection of the experimental treatment or regular injections of the approved medication. Before starting the main part of the study, participants will receive one injection of the approved medication to make sure their condition responds to this type of treatment. During the study, doctors will measure vision using an eye chart and will take images of the eye to see how the condition is changing. The main measurement will be the change in vision after one year of treatment. Doctors will also track how many additional injections are needed and whether the experimental treatment can reduce the need for repeated injections compared to the standard treatment.

The study will last several years and will continue to follow participants to see how long the effects of the treatments last. Throughout the study, participants will have regular visits where their vision will be tested and their eyes will be examined. The study aims to determine whether the single injection of gene therapy can provide lasting benefits and reduce the treatment burden for people with this eye condition.

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

    Screening and Preparation Period

    During the screening visit, your best corrected visual acuity (the clearest vision you can achieve with glasses or contact lenses) will be measured in both eyes using a standardized eye chart.

    Your study eye will be examined using fluorescein angiography (a test where dye is injected into your arm to photograph blood vessels in your eye) and optical coherence tomography (a scanning device that takes detailed images of your retina).

    Your central subfield thickness (the thickness of the central part of your retina) will be measured and must be 500 micrometers or less.

    Between Week -5 and Week -1, you will receive an injection of aflibercept into your study eye to assess your response to treatment. This medication is given as a single intravitreal injection (an injection directly into the gel-filled space of your eye).

    At Week -1, your eye will be examined again to confirm that the thickness of your retina has decreased by at least 15% or that fluid has completely resolved, and that your vision has not decreased by 15 letters or more compared to the screening visit.

  2. Step 2

    Randomization and First Treatment

    On Day 1, you will be randomly assigned to one of two treatment groups. This means you will receive either 4D-150 or aflibercept, but neither you nor your doctor will know which treatment you are receiving.

    If assigned to the 4D-150 group, you will receive a single intravitreal injection of 4D-150 at a dose of 3 ×10^10 vector genomes into your study eye.

    If assigned to the aflibercept group, you will receive an intravitreal injection of aflibercept at a dose of 2 mg into your study eye.

    Following the injection, you will receive difluprednate eye drops to be applied topically (directly onto the surface of your eye) as prescribed by your doctor.

  3. Step 3

    Follow-up Treatment Period (Week 4 through Week 52)

    If you were assigned to the aflibercept group, you will receive additional intravitreal injections of aflibercept at a dose of 2 mg every 8 weeks throughout this period.

    If you were assigned to the 4D-150 group, you will be monitored at regular visits. You may receive additional aflibercept injections if your doctor determines that your eye condition requires further treatment based on examination findings.

    At each visit, your vision will be tested and your retina will be examined using imaging techniques to assess the response to treatment.

  4. Step 4

    Primary Assessment at Week 52

    At Week 52 (approximately one year after your first treatment), your best corrected visual acuity will be measured to determine the change in your vision compared to the beginning of the trial.

    The thickness of your retina will be measured to assess anatomical changes.

    The number of additional injections you received after Week 4 will be recorded.

  5. Step 5

    Extended Follow-up Period (Week 52 through Week 104)

    You will continue to attend regular follow-up visits through Week 104 (approximately two years after your first treatment).

    If you were assigned to the aflibercept group, you will continue receiving intravitreal injections of aflibercept at a dose of 2 mg every 8 weeks.

    If you were assigned to the 4D-150 group, you will continue to be monitored and may receive additional aflibercept injections if needed based on your eye condition.

    Your vision and retinal thickness will continue to be assessed at each visit throughout this period.

  6. Step 6

    Contraceptive Requirements for Male Participants

    If you are a sexually active male, you must use a barrier method of contraception (such as a condom) during sexual intercourse for 3 months after Day 1 to prevent transmission of bodily fluids.

    During this 3-month period, you should not father a child or donate sperm.

Who can join the trial?

12 criteria

  • You must sign a consent form before any tests or evaluations are done for this study
  • Your vision in the study eye must be between 25 and 78 letters on a special eye chart called ETDRS, which is a standard way to measure how well you can see
  • Your vision in the other eye must be at least 34 letters on the ETDRS eye chart
  • Your study eye must be suitable for receiving an injection into the eye, as determined by the doctor
  • You must be able to follow the study procedures and attend all required visits, as judged by the doctor
  • You must be 50 years of age or older
  • If you are a sexually active male, you must use a barrier method such as a condom during sexual intercourse for 3 months after the first treatment day, and you should not father a child or donate sperm during this time
  • You must have macular neovascularization, which means abnormal blood vessel growth in the back of the eye, caused by age-related macular degeneration. You must either have never received eye injections for this condition before, or have received no more than 4 injections, been diagnosed within the last 6 months, and shown improvement with previous treatment
  • You must have active abnormal blood vessel growth in the center area of your eye, which is shown by fluid or leakage on special eye imaging tests called fluorescein angiography or optical coherence tomography
  • The abnormal blood vessel area in your study eye must meet specific size requirements: the total affected area must be 9 disc areas or less, the abnormal blood vessel portion must be at least 50% of the total area, and there must be fluid present on imaging
  • The thickness of the center of your retina, called central subfield thickness, must be 500 micrometers or less in your study eye
  • You must show a positive response to a medication called aflibercept, demonstrated by at least a 15% reduction in retinal thickness or complete disappearance of fluid between specific study visits, and your vision must not have decreased by 15 letters or more on the eye chart

Who cannot join the trial?

3 criteria

  • The study information provided does not include specific exclusion criteria, which are conditions or situations that would prevent a patient from participating in this clinical trial.
  • Exclusion criteria are rules that describe who cannot join the study, such as having certain other eye diseases, taking specific medications, or having particular health conditions that might make the treatment unsafe or affect the results.
  • Without detailed exclusion criteria in the provided information, patients interested in this study would need to have their individual medical situation reviewed by the research team to determine if they are suitable candidates.
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Investigated drugs

  • 4D-150

    is an experimental gene therapy given as a single injection into the eye. It is designed to deliver genetic material that may help treat abnormal blood vessel growth in the back of the eye caused by age-related macular degeneration. The goal is to provide long-lasting treatment with just one injection.

  • Aflibercept

    is an approved medication that is injected into the eye to treat abnormal blood vessel growth in the back of the eye. It works by blocking certain proteins that cause these abnormal blood vessels to grow and leak. In this trial, it is given as an injection every 8 weeks and is used as a comparison treatment to see how well the experimental medication works.

What is already known about the treatment

  • 4D-150

    4D-150 is an investigational gene therapy medication given as a single injection directly into the eye (intravitreal injection) for treating wet age-related macular degeneration, a condition where abnormal blood vessels grow under the retina and can cause vision loss. This experimental treatment is currently being studied in clinical trials to compare its effectiveness against standard treatments, and it works by delivering genetic material that helps produce proteins to block the growth of these abnormal blood vessels. The goal is to provide long-lasting treatment with just one injection instead of requiring repeated injections every few weeks, and it belongs to the class of gene therapy medications that aim to treat disease by modifying cells at the genetic level.

  • Aflibercept

    Aflibercept is an approved medication administered as an injection into the eye (intravitreal injection) every 8 weeks to treat wet age-related macular degeneration, a disease where unwanted blood vessels leak fluid and damage the central part of the retina responsible for sharp vision. This medication is widely used in current medical practice and works by blocking specific proteins called vascular endothelial growth factors that promote the growth of these abnormal blood vessels, thereby reducing fluid leakage and preventing further vision loss. It belongs to a class of drugs known as anti-VEGF agents, which are designed to stop the formation of new blood vessels and reduce swelling in the retina.

Investigated diseases

Macular Neovascularization Secondary to Age-Related Macular Degeneration – This condition occurs when abnormal blood vessels grow beneath the macula, the central part of the retina responsible for sharp, detailed vision. It develops as a complication of age-related macular degeneration, specifically the wet form of the disease. The abnormal blood vessels leak fluid and blood into the retinal tissue, causing damage to the light-sensitive cells. This leakage leads to distortion of vision, with straight lines appearing wavy or bent. As the condition progresses, central vision becomes increasingly blurred and dark spots may appear in the visual field. Without intervention, the disease can advance rapidly, resulting in significant loss of central vision needed for activities like reading and recognizing faces.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521349-25-00Protocol code4D-150-C004Estimated enrolment480 patientsSponsor4d Molecular Therapeutics Inc.

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