Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of OPT-302 and Aflibercept for Patients with Wet Age-related Macular Degeneration

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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, often referred to as wet AMD. This is a common eye disease that can lead to vision loss in older adults. The study is testing a new treatment approach using a combination of two medications: OPT-302 and aflibercept. Aflibercept is already used to treat wet AMD, and the trial aims to see if adding OPT-302 can improve outcomes for patients.

The purpose of the study is to evaluate the effectiveness and safety of this combination treatment compared to using aflibercept alone. Participants in the study will receive injections directly into the eye, a method known as intravitreal use. The study will last for a period of 96 weeks, during which participants will receive regular injections and have their vision monitored to assess any changes.

Throughout the study, some participants will receive a placebo, which is a treatment that looks like the real medication but does not contain any active ingredients. This helps researchers understand the true effects of the medications being tested. The study will measure changes in vision and other eye health indicators to determine the success of the treatment. The goal is to find out if the combination of OPT-302 and aflibercept can provide better results for people with wet AMD.

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 and eye condition.

    Participants must be at least 50 years old and have a specific type of eye condition related to age-related macular degeneration.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish a baseline for visual acuity using a standardized test.

    This assessment helps in measuring changes in vision throughout the study.

  3. Step 3

    Treatment administration

    Participants receive an injection of aflibercept (2.0 mg) into the eye, which is a medication used to treat the eye condition.

    Some participants also receive an additional injection of OPT-302 (2.0 mg) to evaluate its combined effect with aflibercept.

    The injections are administered directly into the eye, a method known as intravitreal use.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled to monitor the condition and any changes in vision.

    These visits include visual acuity tests and imaging of the eye to assess the treatment's effectiveness.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to measure the overall change in vision.

    The primary goal is to determine the mean change in visual acuity from the start of the study to the end.

Who can join the trial?

3 criteria

  • Participants must be **male or female** and at least **50 years old**.
  • Participants must have an **active subfoveal CNV lesion** or a **juxtafoveal CNV lesion** with **foveal involvement** in the eye being studied. A **CNV lesion** is an area in the eye where abnormal blood vessels grow, and **foveal involvement** means it affects the central part of the retina responsible for sharp vision.
  • Participants must have an **ETDRS BCVA score** between **60 and 25 letters** in the eye being studied. This score is a way to measure vision clarity, with a higher number indicating better vision.

Who cannot join the trial?

10 criteria

  • Patients who have any other eye diseases that could affect the study results.
  • Patients who have had eye surgery in the last three months.
  • Patients who are currently receiving treatment for another eye condition.
  • Patients who have a history of severe allergic reactions to medications used in the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have had a stroke or heart attack in the last six months.
  • Patients who have any serious health conditions that could interfere with the study.
  • Patients who are participating in another clinical trial.
  • Patients who are unable to follow the study procedures or attend study visits.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • OPT-302

    is an investigational medication being studied for its potential to treat neovascular age-related macular degeneration (nAMD). It is administered through an injection into the eye, known as an intravitreal injection. The purpose of this medication in the trial is to evaluate its effectiveness and safety when used in combination with another medication, aflibercept, to improve vision in patients with nAMD.

  • Aflibercept

    is a medication already used to treat neovascular age-related macular degeneration (nAMD). It works by blocking the growth of abnormal blood vessels in the eye, which can help prevent vision loss. In this trial, aflibercept is used both alone and in combination with OPT-302 to compare the outcomes and determine if the combination provides better results for patients with nAMD.

What is already known about the treatment

  • OPT-302

    This medication is administered through an injection into the eye, known as intravitreal injection. It is currently being studied in clinical trials for its effectiveness in treating neovascular age-related macular degeneration (wet AMD). The main therapeutic indication is to improve vision in patients with this condition. At the molecular level, OPT-302 works by blocking specific proteins that contribute to abnormal blood vessel growth in the eye. It is classified as an anti-angiogenic agent.

  • Aflibercept

    This medication is also administered via intravitreal injection. It is an established treatment for neovascular age-related macular degeneration (wet AMD) and is widely used in medical practice. Aflibercept helps to prevent vision loss by inhibiting the growth of abnormal blood vessels in the eye. It achieves this by binding to and blocking the activity of proteins that promote blood vessel formation. Aflibercept is classified as a vascular endothelial growth factor (VEGF) inhibitor.

Investigated diseases

Neovascular Age-related Macular Degeneration (wet AMD) – This is a chronic eye disorder that causes blurred vision or a blind spot in your visual field. 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, damaging the retina and leading to vision loss. The disease progresses as these abnormal blood vessels continue to grow and leak, further impairing vision. Over time, this can result in significant vision impairment if not managed. Wet AMD is one of the leading causes of vision loss in older adults.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512880-30-00Protocol codeOPT-302-1005Estimated enrolment998 patientsSponsorOpthea Limited

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.