Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Early Reperfusion Therapy with Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion (REVISION) - A double-blind randomized placebo-controlled phase III trial

The REVISION study is a research trial exploring a new way to treat sudden vision loss caused by a blockage in the central retinal artery of the eye. This blockage is like a 'mini-stroke' in the eye. The study is testing a medicine called tenecteplase (also known as Metalyse) to see if it can quickly unblock the vessel and help people get their vision back. This is a Phase 3 study, meaning it's a key stage to confirm if the treatment works and is safe. Researchers will compare tenecteplase to a placebo (a dummy treatment) to understand its effects, focusing on vision improvements about a month after treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitaetsklinikum Tuebingen AöR

Enrolment target

1,422

Start

18 Oct 2023

Acute non-arteritic central retinal artery occlusion (CRAO)

What is this study about?

Imagine your eye needs a constant supply of fresh blood, just like any other part of your body. Sometimes, a tiny blood vessel that supplies the main nerve in your eye gets blocked. This is a bit like a 'mini-stroke' happening in your eye and can cause sudden, significant vision loss. It's called a central retinal artery occlusion, and it needs urgent attention.

The REVISION study is looking into a medicine called tenecteplase (you might hear it called Metalyse) which is already used to treat blood clots in other parts of the body, like during a heart attack. The idea is that if this medicine is given early, it could dissolve the clot in your eye and restore blood flow, hopefully saving your vision.

This study is a 'Phase 3' trial, which means it's a big, important step to find out if tenecteplase is a safe and effective treatment for this specific eye condition. Researchers want to see if people who receive the treatment have better vision outcomes compared to those who receive a placebo (a dummy treatment, which looks exactly like the real medicine but contains no active drug). This type of study is called 'double-blind,' meaning neither you nor your doctors will know if you're getting the active medicine or the placebo, to make sure the results are as fair and unbiased as possible.

Key takeaways

The study is investigating a new treatment for sudden vision loss caused by a blocked eye artery.
It tests a clot-dissolving medicine called tenecteplase (Metalyse).
It's a 'double-blind' study, meaning some participants get active medicine, and others get a placebo.
The main goal is to see if the medicine helps improve vision significantly.
Participation involves IV treatment and several follow-up eye exams over three months.

Who may be eligible?

You might be able to take part in this study if you are 18 years old or older and have recently experienced sudden vision loss due to a blocked central retinal artery in one of your eyes. This condition will need to be confirmed by a doctor.

The study is looking for people who haven't had other serious eye conditions that might affect their vision, or other medical conditions that would make taking the study medicine unsafe. Both men and women are eligible to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently experienced sudden vision loss in one eye?
Has a doctor confirmed this is due to a central retinal artery occlusion?
Do you have any other serious medical conditions that might prevent you from taking new medicines?
Are you able to attend follow-up appointments for approximately three months?

Answer every question to see your result.

What does participation involve?

If you decide to join the REVISION study, you will be given an intravenous (IV) infusion of either the study medicine (tenecteplase) or a placebo through a drip in your arm. Neither you nor your doctor will know which one you are receiving. You will have several check-ups over about three months. The first check-up will be soon after you receive the treatment (within 18-72 hours), followed by another about 30 days later, and a final check-up around 90 days after treatment.

During these visits, doctors will measure your vision carefully using special charts (like the ones you see at the optician, but more detailed). They will also do various eye scans and tests to check the blood flow in your eye and the health of your retina. Some tests might include special eye photography and scans that look at the tiny blood vessels. You might also be asked to fill out questionnaires about how your vision affects your daily life and receive overall health checks, including a brain scan (MRI) shortly after treatment to ensure safety. The total duration of your active participation, including follow-up visits, will be approximately 90 days.

Potential risks and benefits

Participating in this study means you might be among the first to receive a potentially effective treatment for central retinal artery occlusion, which could help improve or restore your vision. However, like all medicines, tenecteplase can have side effects, including a risk of bleeding, which will be closely monitored. There's also a chance you might receive the placebo and not the active drug. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is 'central retinal artery occlusion'?

It's like a 'mini-stroke' in your eye, where a blood vessel gets blocked, causing sudden vision loss.

What is tenecteplase (Metalyse)?

It's a medicine that helps dissolve blood clots. It's being tested in this study to see if it can unblock the vessel in your eye.

What does 'double-blind' mean?

It means neither you nor your doctors helping with the study will know if you're getting the active medicine or a dummy treatment (placebo).

How long will I be in the study?

You will have follow-up visits and assessments over approximately 90 days (about three months).

Can I choose not to finish the study?

Yes, you can leave the study at any time for any reason, and your medical care will not be affected.