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Study on the Effectiveness of OPT-302 and Ranibizumab for Patients 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 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 that combines two medications: OPT-302 and ranibizumab. OPT-302 is a solution for injection that targets specific proteins involved in the growth of abnormal blood vessels in the eye. Ranibizumab is a well-known medication already used to treat wet AMD, and it is also given as an injection into the eye.

The purpose of this study is to evaluate how effective and safe the combination of OPT-302 and ranibizumab is compared to using ranibizumab alone. Participants in the study will receive regular injections of these medications over a period of time. Some participants will receive both OPT-302 and ranibizumab, while others will receive only ranibizumab. There is also a possibility of receiving a placebo, which is an inactive substance. The study will monitor changes in vision and eye health to determine the effectiveness of the treatment.

Throughout the study, participants will have regular check-ups to assess their vision and the condition of their eyes. The study aims to see if the combination of these medications can improve vision more effectively than the standard treatment alone. This research could potentially lead to better treatment options for people with wet AMD, helping to preserve their vision and improve their quality of life.

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, participants are required to meet specific criteria, including being at least 50 years old and having a certain type of eye condition related to age-related macular degeneration (AMD).

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition of the eye. This includes measuring visual acuity using a standardized test known as ETDRS BCVA, which assesses the ability to read letters on a chart.

  3. Step 3

    Treatment administration

    Participants receive an injection of OPT-302 combined with ranibizumab or ranibizumab alone. The injection is administered directly into the eye, a method known as intravitreal use.

    The dosage for OPT-302 is 2.0 mg, and for ranibizumab, it is 0.5 mg. These injections are given as part of the treatment plan for neovascular AMD.

  4. Step 4

    Follow-up visits

    Regular follow-up visits are scheduled to monitor the progress of the treatment. These visits include assessments similar to the initial evaluation, focusing on changes in visual acuity and the condition of the eye.

  5. Step 5

    Final assessment

    At the end of the study period, a final assessment is conducted to determine the overall effectiveness of the treatment. This includes measuring the change in visual acuity from the start of the study to the end, approximately 52 weeks later.

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 study eye. This means there is a problem with the blood vessels in the eye related to **age-related macular degeneration (AMD)**.
  • Participants must have an **ETDRS BCVA score** between **60 and 25 letters** in the study eye. This score is a way to measure how well you can see.

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 within the last three months.
  • Patients who are currently receiving or have received certain treatments for eye conditions in the past three months.
  • Patients with a history of severe allergic reactions to any of the study medications.
  • Patients who have uncontrolled high blood pressure.
  • Patients with any serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who are unable to comply with the study procedures.
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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 goal of using OPT-302 is to improve vision by targeting specific pathways involved in the disease process.

  • Ranibizumab

    is a medication commonly used to treat neovascular age-related macular degeneration (nAMD). It is also given as an intravitreal injection. Ranibizumab works by inhibiting a protein that contributes to the growth of abnormal blood vessels in the eye, which can lead to vision loss. In this study, it is used both alone and in combination with OPT-302 to evaluate the effectiveness of the combination therapy.

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 eye condition. 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.

  • Ranibizumab

    This medication is also administered via intravitreal injection and is well-established in medical practice for treating neovascular age-related macular degeneration (wet AMD). It is used to prevent vision loss and improve vision by inhibiting a protein that causes abnormal blood vessel growth in the eye. Ranibizumab is classified as a monoclonal antibody fragment that targets vascular endothelial growth factor (VEGF).

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 damage to the macula, the part of the retina responsible for central vision. As the disease progresses, it can lead to rapid and severe vision loss. Wet AMD is more severe than its counterpart, dry AMD, and can develop quickly. It primarily affects older adults and is a leading cause of vision loss in this age group.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512879-13-00Protocol codeOPT-302-1004Estimated enrolment986 patientsSponsorOpthea Limited

sourced from the EU Clinical Trials Register and site verification

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