Rare diseases
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2 clinical trials in this condition
Belgium
GermanyIn short
Currently, there are 2 ongoing clinical trials investigating treatments for retinal artery occlusion, a condition where blood flow to the eye's retina becomes blocked, causing sudden vision loss. These trials are testing clot-dissolving medications to help restore vision in affected patients and are being conducted across several European countries including Sweden, Norway, Finland, Belgium, Denmark, Ireland, and Germany.
This trial is comparing two different treatment approaches for people who have experienced central retinal artery occlusion, a condition where the main blood vessel supplying the retina becomes blocked, leading to sudden vision loss. The study focuses on patients whose symptoms started within the last 4.5 hours, as early treatment is critical for potentially restoring vision.
Main inclusion criteria: To participate, you must have confirmed central retinal artery occlusion with significantly reduced vision, with symptoms that started less than 4.5 hours ago. You need to be at least 18 years old and able to provide written consent to join the study. The treatment must be given within 4.5 hours from when your symptoms first appeared. Women who can become pregnant will need to confirm they are not currently pregnant or have a negative pregnancy test before receiving treatment.
Main exclusion criteria: You cannot participate if you are younger than 18 or older than 85 years of age. People with bleeding disorders, active bleeding, or recent major surgery within the past two weeks are not eligible. If you have had a stroke in the past three months, have uncontrolled high blood pressure (above 185/110 mmHg), are currently taking blood thinners, or are pregnant or breastfeeding, you cannot join this study. Those with severe liver or kidney disease, previous allergic reactions to similar medications, blood sugar levels outside the safe range, or symptoms lasting longer than 4.5 hours are also excluded.
Focus and goal: The trial aims to evaluate whether tenecteplase, a clot-dissolving medication, can effectively improve vision when given within 4.5 hours of symptom onset. The study uses a double-blind design, meaning neither patients nor doctors know which treatment each participant receives during the trial. Participants will receive either tenecteplase through an intravenous injection plus an inactive tablet, or acetylsalicylic acid (aspirin) as a tablet plus an inactive injection. The main measure of success is whether vision improves to a score of 0.7 logMAR or better after 30 days of treatment.
Investigational drugs: Tenecteplase is the primary medication being studied. It works by breaking down blood clots that block the artery supplying blood to the retina. This medication is given as a single dose through an intravenous injection at a dose of 0.25 mg per kilogram of body weight. Acetylsalicylic acid (aspirin) serves as the comparison treatment in this trial. It is a blood-thinning medication that helps prevent blood clots from forming by making blood platelets less sticky.
This clinical trial is investigating whether alteplase, a clot-dissolving medication, can help restore vision in people who have experienced acute central retinal artery occlusion. This condition causes sudden, painless vision loss in one eye due to a blockage in the main artery that supplies blood to the retina. The study compares alteplase treatment with a placebo to determine if early intervention can lead to meaningful vision recovery.
Main inclusion criteria: You must be 18 years or older to participate. You need to have acute non-arteritic central retinal artery occlusion that occurred within 12 hours of symptom onset, confirmed by an eye doctor through various tests including vision clarity checks, eye pressure measurements, pupil response, and detailed eye examinations. Your vision in the affected eye must be at a level of LogMAR 1.3 or worse, which represents functional blindness. Before the occlusion occurred, you must have been able to read with the affected eye, with vision of LogMAR 0.5 or better. You will undergo a neurological examination by a stroke specialist and brain imaging using either a CT scan or MRI to check for related conditions.
Main exclusion criteria: You cannot participate if you have any other eye condition that could interfere with the study results or if you have had eye surgery in the last three months. People with a history of severe allergic reactions to medications, those currently in another clinical trial, or those with uncontrolled high blood pressure are not eligible. If you have a history of drug or alcohol abuse, are pregnant or breastfeeding, or have any serious medical condition that could affect the study, you cannot join. You must also be able to follow study procedures and attend all study visits.
Focus and goal: The primary goal of this study is to determine if treatment with alteplase can help patients achieve normal to mild vision impairment as defined by the World Health Organization. The study follows participants over 90 days, with vision assessments at multiple time points. The first follow-up occurs 18 to 72 hours after treatment to check for initial vision changes. A key assessment happens at 30 days to evaluate functional recovery, and a final comprehensive evaluation takes place at 90 days. Throughout the study, researchers will examine various aspects of eye health, including retinal artery blood flow restoration and overall vision quality.
Investigational drug: Alteplase is the medication being tested in this trial. It is given through an intravenous route as a solution for injection or infusion. Alteplase works by converting plasminogen to plasmin, an enzyme that breaks down the fibrin in blood clots. By dissolving the clot blocking the central retinal artery, alteplase may help restore blood flow to the retina, potentially allowing for vision recovery. The specific dosage and administration schedule are determined by the study protocol and administered under medical supervision.
Both ongoing trials for retinal artery occlusion focus on using clot-dissolving medications to restore vision following sudden blockage of blood flow to the retina. A notable difference between the trials is the treatment window: one study requires treatment within 4.5 hours of symptom onset, while the other allows up to 12 hours. This reflects ongoing research into the optimal time frame for intervention in this urgent condition.
The trials are testing different thrombolytic medications—tenecteplase and alteplase—both of which work by breaking down blood clots. The first trial includes a comparison with aspirin, a commonly used blood-thinning medication, while the second compares the investigational drug with a placebo. Geographically, these trials show concentration in Northern European countries, with the tenecteplase study spanning multiple countries including Sweden, Norway, Finland, Belgium, Denmark, and Ireland, while the alteplase study is being conducted in Germany.
Both studies emphasize the importance of quick treatment, detailed neurological and eye examinations, and careful monitoring of vision recovery over time. These trials represent important research efforts to find effective treatments for a condition that can lead to permanent vision loss if not treated promptly.
This guide is here to help you understand the condition. It does not replace a conversation with your doctor, who knows your situation best.
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