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Study on Alteplase for Vision Recovery in Patients with Acute Central Retinal Artery Occlusion

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 clinical trial is focused on studying a condition called Acute Central Retinal Artery Occlusion (CRAO), which is a sudden blockage of blood flow to the main artery of the eye, leading to a quick and painless loss of vision in one eye. The study is testing a treatment called Alteplase, which is a medication that helps dissolve blood clots. The trial will compare the effects of Alteplase with a placebo to see if it can help improve vision in people who have experienced this type of eye blockage.

The purpose of the study is to see if early treatment with Alteplase can help recover vision in patients with Acute Central Retinal Artery Occlusion. Participants in the study will receive either the Alteplase treatment or a placebo. The study will monitor the participants' vision over a period of time to assess any improvements. The main goal is to achieve a level of vision that is considered normal to mild impairment, as defined by the World Health Organization.

Throughout the study, participants will have their vision checked at different times to see how well they are recovering. The study will also look at other aspects of eye health and vision quality. The trial aims to provide valuable information on whether Alteplase can be an effective treatment for improving vision in patients with this sudden eye condition.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a detailed eye examination by an ophthalmologist to assess vision loss and other eye health indicators.

    A neurological examination is performed by a stroke specialist, and brain imaging is conducted using either a CT or MRI scan to assess for any signs of stroke or retinal ischemia.

  2. Step 2

    Treatment administration

    The treatment involves the administration of alteplase or a placebo. Alteplase is given as a solution for injection or infusion through an intravenous route.

    The specific dosage and frequency are determined by the study protocol, and the treatment is administered under medical supervision.

  3. Step 3

    Follow-up visit 1

    The first follow-up visit occurs between 18 to 72 hours after treatment. During this visit, visual acuity is assessed to determine any initial changes in vision.

    Additional tests may include an evaluation of the visual field and other eye health assessments.

  4. Step 4

    Follow-up visit 2

    The second follow-up visit is scheduled approximately 30 days after treatment. The primary goal is to assess functional recovery of vision.

    Tests include a detailed eye examination, visual acuity assessment, and possibly imaging tests to evaluate retinal artery recanalization and perfusion.

  5. Step 5

    Final follow-up visit

    The final follow-up visit takes place around 90 days post-treatment. This visit includes a comprehensive evaluation of visual function and any changes in vision impairment categories.

    Additional assessments may include visual field tests, retinal imaging, and quality of life questionnaires.

Who can join the trial?

6 criteria

  • Must be **18 years or older**.
  • Must have **acute non-arteritic CRAO**, which means a sudden and painless loss of vision in one eye, occurring within **12 hours** of the start of symptoms. This must be confirmed by an eye doctor using various tests like checking vision clarity, eye pressure, pupil response, and examining the eye with special equipment.
  • Must have a vision clarity measurement of **LogMAR 1.3 or worse** in the affected eye, which is considered functional blindness.
  • Must have been able to read with the affected eye before the CRAO event, with a vision clarity measurement of **LogMAR 0.5 or better**.
  • Must undergo a **neurological examination** by a doctor who specializes in strokes.
  • Must have **brain imaging** done, which could be a CT scan or an MRI, to check for any issues related to the eye condition or stroke.

Who cannot join the trial?

9 criteria

  • Patients with any other eye condition that could affect the study results.
  • Patients who have had eye surgery in the last 3 months.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are pregnant or breastfeeding.
  • Patients with any serious medical condition that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend study visits.
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Investigated drugs

Alteplase is a medication used in this trial to help restore vision in patients who have experienced a sudden blockage in the central retinal artery of the eye. It works by dissolving the blood clot that is causing the blockage, potentially improving blood flow and aiding in the recovery of vision.

What is already known about the treatment

Alteplase – Alteplase is administered intravenously and is currently being studied in a phase III clinical trial for its effectiveness in treating acute non-arteritic central retinal artery occlusion (CRAO). This medication is well-documented in medical literature as a thrombolytic agent, primarily used to dissolve blood clots. Its main therapeutic indication in this trial is to improve visual acuity in patients with CRAO. At the molecular level, alteplase works by converting plasminogen to plasmin, an enzyme that breaks down fibrin clots. It is classified pharmacologically as a tissue plasminogen activator.

Investigated diseases

Acute Non-Arteritic Central Retinal Artery Occlusion (CRAO) – This condition occurs when the central retinal artery, which supplies blood to the retina, becomes blocked. It typically results in sudden, painless vision loss in one eye. The blockage is usually caused by an embolus or thrombus, leading to a lack of oxygen and nutrients to the retina. Without adequate blood flow, the retinal cells can become damaged, affecting vision. The progression of CRAO can lead to varying degrees of visual impairment, depending on the duration and extent of the blockage. Early intervention is crucial to potentially restore some vision, but the condition can lead to permanent vision changes.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507388-21-00Protocol codeREVISIONEstimated enrolment1 422 patientsSponsorUniversitaetsklinikum Tuebingen AöR

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.

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