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Study Comparing EYP-1901 and Aflibercept for Patients with Wet Age-Related Macular Degeneration

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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 wet age-related macular degeneration (wAMD), which affects the eyes and can lead to vision loss. The study will compare two treatments: an implant called EYP-1901, which contains a substance known as vorolanib, and a solution for injection called Eylea, which contains aflibercept. EYP-1901 is designed to be placed inside the eye, while Eylea is given as an injection. Both treatments aim to help improve or maintain vision in people with wAMD.

The purpose of the study is to evaluate how well EYP-1901 works in comparison to aflibercept in improving vision. Participants in the study will receive either the EYP-1901 implant or aflibercept injections. The study will last for up to 96 weeks, during which time the effects of the treatments on vision and the structure of the retina, the light-sensitive layer at the back of the eye, will be monitored. The study will also look at how many additional injections of aflibercept might be needed over the course of the study.

Throughout the study, changes in vision and the thickness of the retina will be assessed. The primary goal is to determine if EYP-1901 can provide similar vision benefits as aflibercept over a period of 56 weeks. Additionally, the study will track the number of injections required and any changes in the retina's structure and function over the full 96 weeks. This research aims to provide valuable information on the effectiveness of EYP-1901 as a treatment option for individuals with wet age-related macular degeneration.

The research process

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

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as age and willingness to comply with study requirements.
You will be asked to sign an informed consent form, which explains the study details and your rights as a participant.
Step 2
Treatment assignment
You will be randomly assigned to receive either the EYP-1901 implant or aflibercept injections. This process is double-masked, meaning neither you nor the study staff will know which treatment you are receiving to ensure unbiased results.
Step 3
Treatment administration
If assigned to the EYP-1901 group, you will receive an intravitreal implant, which is a small device placed inside the eye. This implant contains the active substance vorolanib and is designed to release the medication over time.
If assigned to the aflibercept group, you will receive injections directly into the eye. These injections are given as a solution and are administered at regular intervals as determined by the study protocol.
Step 4
Follow-up visits
You will attend regular follow-up visits to monitor your eye health and vision. These visits will include assessments of your visual acuity, which is how well you can see details at a distance.
The thickness of your retina will also be measured to assess any changes over time. These visits are scheduled from Week 12 through Week 56, and may continue up to 96 weeks.
Step 5
Additional treatments
Depending on your response to the initial treatment, you may receive additional aflibercept injections if necessary. The total number of these supplemental injections will be recorded as part of the study.
Step 6
Study completion
The primary goal of the study is to determine if EYP-1901 can provide the same vision benefits as aflibercept over a period of 56 weeks.
Secondary goals include evaluating the number of additional injections needed and changes in the retina's structure and function over the course of the study, which may last up to 96 weeks.

Who can join the trial?

4 criteria

Participants must be male or female and at least 50 years old.
Participants must be able to understand and willing to sign a document called informed consent, which gives permission to use their health information for the study.
Participants must be willing and able to attend all scheduled visits and follow the study's rules and assessments.
If participants are women who can have children, or men with female partners who can have children, they must agree to use a suitable form of contraception (birth control) from the start of the study and throughout its duration.

Who cannot join the trial?

10 criteria

Patients with any other eye diseases that could affect vision.
Patients who have had eye surgery in the last 3 months.
Patients with an eye infection or inflammation.
Patients who are allergic to any of the study medications.
Patients who are pregnant or breastfeeding.
Patients with uncontrolled high blood pressure.
Patients with a history of stroke or heart attack in the last 6 months.
Patients who are participating in another clinical trial.
Patients with a history of drug or alcohol abuse.
Patients with any condition that the study doctor believes would make participation unsafe.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Axon Clinical s.r.o.
Prague, Czechia
Responsive
Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia
Responsive
Semmelweis University
Budapest, Hungary

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Investigated drugs

EYP-1901
is a new type of treatment being tested for people with wet age-related macular degeneration (AMD), a condition that affects vision. It works by blocking certain signals in the body that can cause abnormal blood vessels to grow in the eye, which can lead to vision problems. This medication is given as an injection directly into the eye, and the study is looking at how well it helps improve vision compared to another treatment.
Aflibercept
is a medication already used to treat wet age-related macular degeneration (AMD). It helps to stop the growth of abnormal blood vessels in the eye, which can improve vision or prevent it from getting worse. Aflibercept is also given as an injection into the eye, and in this study, it is being used as a comparison to see how well the new treatment, EYP-1901, works.

What is already known about the treatment

EYP-1901
EYP-1901 is administered as an intravitreal (IVT) insert, meaning it is placed directly into the eye. It is currently being studied in clinical trials for its effectiveness in treating wet age-related macular degeneration (wAMD), a condition that affects vision. EYP-1901 works by inhibiting tyrosine kinase, a type of protein that plays a role in the growth of abnormal blood vessels in the eye, which can lead to vision loss. It is classified as a tyrosine kinase inhibitor (TKI), a type of medication that blocks specific enzymes involved in disease progression.
Aflibercept
Aflibercept is administered through an injection into the eye, known as an intravitreal injection. It is an established treatment for wet age-related macular degeneration (wAMD), a condition that can cause severe vision loss. Aflibercept works by blocking a protein called vascular endothelial growth factor (VEGF), which is responsible for the growth of abnormal blood vessels in the eye. By inhibiting VEGF, aflibercept helps reduce swelling and prevents further damage to the retina, thereby preserving vision. It is classified as an anti-VEGF medication.

Investigated diseases

Wet age-related macular degeneration (wAMD) – This disease affects the central part of the retina, known as the macula, which is responsible for sharp, central 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 from its normal position, resulting in rapid and severe vision loss. The progression of wAMD can lead to a significant decrease in the ability to see fine details, both up close and at a distance. Over time, the disease can cause permanent damage to the macula, leading to a loss of central vision. Peripheral vision usually remains unaffected, but the central vision loss can significantly impact daily activities.