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Study comparing tenecteplase and acetylsalicylic acid in patients with central retinal artery occlusion within 4.

Fast replyRegistered 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 focuses on central retinal artery occlusion, a condition where blood flow to the eye's retina becomes blocked, which can cause sudden vision loss. The research compares two different treatments: tenecteplase, a medication given through an intravenous injection, and acetylsalicylic acid (also known as aspirin), which is taken as a tablet.

The purpose of this research is to evaluate how effective tenecteplase is when given within 4.5 hours after the first symptoms of central retinal artery occlusion appear. During the study, participants will receive either tenecteplase with a placebo tablet or acetylsalicylic acid with a placebo injection. Neither the patients nor the doctors will know which treatment each participant receives during the study.

The study will monitor changes in vision over time, particularly focusing on vision improvement after 30 days of treatment. Participants will receive either a single dose of tenecteplase through an intravenous injection or acetylsalicylic acid tablets. Some participants will also receive sodium chloride solution (normal saline) as part of their treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial vision assessment

    Your vision will be tested to confirm central retinal artery occlusion (a blockage in the blood vessel of the eye) and verify that your vision score is at least 1.0 logMAR

    The assessment must occur within 4.5 hours from when your symptoms began

  2. Step 2

    Medical eligibility check

    Your eligibility for the study will be confirmed based on age (must be 18 or older)

    If you are a woman who can become pregnant, a pregnancy test may be required

  3. Step 3

    Treatment administration

    You will receive one of two possible treatments:

    Option 1: Tenecteplase (0.25 mg per kg of body weight) given through an intravenous injection, plus an inactive tablet

    Option 2: Acetylsalicylic acid (Albyl-E 75 mg) tablet taken by mouth, plus an inactive intravenous solution

    Neither you nor your doctor will know which treatment you receive

  4. Step 4

    Follow-up vision assessment

    Your vision will be tested again after 30 days (plus or minus 5 days)

    The test will measure if your vision has improved to a score of 0.7 logMAR or better

Who can join the trial?

6 criteria

  • You must have a condition called central retinal artery occlusion (a blockage in the blood vessel that supplies blood to your retina) with significantly reduced vision and symptoms that started less than 4.5 hours ago
  • You must be able to receive the study medication within 4.5 hours from when your symptoms first started
  • You must be at least 18 years old
  • You must be able to provide written informed consent to participate in the study
  • If you are a woman who can become pregnant, you must either:
    • Confirm that you cannot be pregnant at the moment
    • If there is a possibility of pregnancy, have a negative pregnancy test before receiving the study medication

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 85 years
  • Presence of any bleeding disorders or active bleeding
  • Recent major surgery within the past 14 days
  • History of stroke in the past 3 months
  • Uncontrolled high blood pressure (blood pressure higher than 185/110 mmHg)
  • Current use of blood thinners (anticoagulants)
  • Pregnancy or breastfeeding
  • Known severe liver or kidney disease
  • Previous allergic reactions to tenecteplase or similar medications
  • Symptoms lasting longer than 4.5 hours
  • Active internal bleeding or history of bleeding in the brain
  • Severe heart disease or recent heart attack
  • Blood sugar levels below 50 mg/dL or above 400 mg/dL
  • Current participation in other clinical trials
  • Inability to provide informed consent
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Investigated drugs

  • Tenecteplase (TNK)

    is a medication used to break up blood clots. In this trial, it is being studied for treating central retinal artery occlusion (CRAO), which is a blockage in the blood vessel that supplies the retina. The medication works by helping to dissolve the clot that is blocking blood flow to the eye.

  • Aspirin (ASA)

    is a common blood-thinning medication that helps prevent blood clots from forming. It works by making blood platelets less sticky, which reduces the chance of clots forming in blood vessels. In this trial, it serves as an active comparison treatment for patients with central retinal artery occlusion.

What is already known about the treatment

Tenecteplase – A thrombolytic medication administered intravenously that is being studied for the treatment of central retinal artery occlusion (CRAO). This modified form of tissue plasminogen activator (tPA) works by breaking down blood clots through enzymatic action, potentially restoring blood flow to the affected retina. The drug has a faster onset of action and greater fibrin specificity compared to traditional thrombolytics, making it particularly interesting for emergency situations where quick restoration of blood flow is crucial. Currently being investigated in phase 3 clinical trials at a dose of 0.25 mg/kg, tenecteplase represents a potential new treatment option for patients suffering from sudden vision loss due to CRAO.

Investigated diseases

Central Retinal Artery Occlusion - A condition where blood flow through the central retinal artery becomes blocked, cutting off blood supply to the retina. The blockage typically occurs when a blood clot or piece of fatty deposit (embolus) gets lodged in the artery. The retina, which is the light-sensitive tissue at the back of the eye, becomes deprived of oxygen and nutrients. This condition usually develops suddenly and affects one eye at a time. The lack of blood flow causes the retinal cells to become damaged, leading to vision problems in the affected eye. Vision loss typically occurs in the central field of vision while peripheral vision may remain intact.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517606-29-00Estimated enrolment78 patientsSponsorOslo University Hospital HF

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).