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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Universitaetsmedizin Goettingen Goettingen Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Universitaet Leipzig Leipzig Germany
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Universitaetsklinikum Regensburg AöR Regensburg Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Saarland University Hospital Homburg Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn Bonn Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Aachen AöR Aachen Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen Am Rhein Germany
Deutsches Herzzentrum Berlin Berlin Germany
Knappschaft Kliniken Saar GmbH Sulzbach Germany
Uryashhmgydgsodjfgnnm Dpswrbfgkae Alg Duesseldorf Germany
Ukfycsbovlduvbplehnsn Mmgzljfl Acl Munster Germany
Giizld Uthkrsitlb Fjlhqqdgl Frankfurt Germany
Kdouengm dxb Uawsvpditsdd Mfnnjxak Afe Munich Germany
Urhonubrjeefljuxeefdr Wxcfmqxaa Asy Wuerzburg Germany
Uiownwzcor Mrgltle Csnzdl Hvhwaqckweqmmiwvj Hamburg Germany
Mthtfmrcqpuudyocpvzickifzf Hkgdzozymoihpyso Halle (Saale) Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.09.2022

Trial locations

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.

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 ID:
2023-507388-21-00
Protocol code:
REVISION
NCT ID:
NCT04965038
Trial Phase:
Therapeutic confirmatory (Phase III)

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