Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Multicenter randomized controlled trial of the value of intravitreal anti-VEGF injections as initial then adjuvant treatment in Coats' disease

This research is a clinical trial exploring a new approach to treating Coats' disease, a rare eye condition that can affect vision. Doctors are testing whether a medication given as an injection directly into the eye (called anti-VEGF, specifically Avastin) can help improve the disease more effectively than current methods. The study will compare patients receiving these injections, either as the main treatment or alongside other treatments, to those receiving standard care. Scientists want to see if the injections can improve the disease by at least one stage according to a recognised eye classification system. The trial is in an early phase (Phase II), meaning it's focused on understanding if the treatment works and is safe, rather than being a final test for widespread use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondation A De Rothschild

Enrolment target

Start

06 Nov 2024

Coats' disease

What is this study about?

Coats' disease is a rare eye condition, mostly affecting children, where blood vessels in the retina (the light-sensitive lining at the back of the eye) develop abnormally. These abnormal vessels can leak fluid and fats, causing a build-up that can lead to vision loss, and in severe cases, even blindness. Currently, treatments often involve laser therapy or freezing treatments (cryotherapy) to seal the leaky blood vessels and prevent further damage. However, these treatments aren't always enough.

This study is looking into a new treatment option involving a medicine called anti-VEGF, specifically Avastin, which is given as an injection directly into the eye. Anti-VEGF medicines work by blocking a protein that encourages blood vessel growth and leakage. The idea is that by reducing this leakage, the disease might improve more effectively than with existing treatments alone.

The trial aims to find out if these injections can improve the condition by at least one stage (based on how doctors classify Coats' disease) over several months. It will also compare how well people in the study see, how much fluid is in their eye, and if they need other treatments or experience any side effects. This is a "Phase II" study, which means it's an early stage to see if the treatment is safe and shows promise for helping patients with Coats' disease.

Key takeaways

This study is testing new eye injections (Avastin) for Coats' disease.
It's an early-stage study to see if the treatment is safe and effective.
Participants will have regular eye exams over 9 months.
The goal is to see if the injections improve the disease or reduce the need for other treatments.
Participation involves eye injections, which carry some risks.

Who may be eligible?

This study is looking for patients of any age who have Coats' disease. There are no restrictions based on whether you are male or female.

However, to join the study, you would need to be diagnosed with Coats' disease. The doctors running the trial would carefully check your specific situation to make sure the study is a good fit for you.

Quick self-check

Do you have Coats' disease?
Are you willing to have regular eye check-ups?
Are you comfortable with the idea of eye injections?
Are you able to commit to 9 months of study participation?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two groups: one receiving the anti-VEGF injections or one receiving standard care, or a combination. The treatment involves injections directly into the eye, and you would have regular follow-up appointments over about 9 months. During these visits, doctors would perform eye examinations, including special scans and photographs of your retina, and check your vision. They would also monitor for any side effects. The total duration of active participation in the study, where your treatment and eye checks are closely monitored, would be about 9 months.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment that might improve your Coats' disease. However, as with any medical treatment, there are potential risks associated with eye injections, including infection, bleeding, or other eye complications. The study will carefully monitor for any side effects. It’s important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

—
France

Common questions

What is Coats' disease?

Coats' disease is a rare eye condition where abnormal blood vessels in the retina leak fluid, potentially causing vision loss.

What are 'anti-VEGF injections'?

These are medicines, like Avastin in this study, injected into the eye to stop abnormal blood vessels from leaking and growing.

What is a 'Phase II' clinical trial?

It's an early stage of research to see if a new treatment is safe and if it seems to work for the condition being studied.

Will I definitely get the new treatment?

Participants are randomly assigned to either receive the new injections (alone or with other care) or standard care, so you might not get the new treatment.

How long does the study last?

Your active participation, with treatments and close monitoring, would last for about 9 months.