Study on Bevacizumab Injections for Patients with Coats’ Disease

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What is this study about?

This clinical trial is focused on studying a rare eye condition called Coats’ disease. This disease affects the blood vessels in the retina, which is the light-sensitive layer at the back of the eye, and can lead to vision problems. The study is investigating the use of a treatment called Avastin, which contains the active substance bevacizumab. Avastin is given as an injection directly into the eye, a method known as intravitreal injection. The purpose of the study is to compare the effectiveness of Avastin with a standard treatment called laser photocoagulation, which uses a laser to seal off abnormal blood vessels in the eye.

Participants in the study will receive either the Avastin injections or the laser treatment. The study will last for about six months, during which the progress of the disease will be monitored. The main goal is to see if Avastin can improve the condition of the eye by at least one stage, according to a specific classification system used by eye doctors. The study will also look at other factors, such as changes in vision and the thickness of the retina, to understand the overall impact of the treatment.

Throughout the study, participants will have regular check-ups to assess their eye health and any changes in their condition. The study aims to provide valuable information on whether Avastin can be a beneficial treatment option for people with Coats’ disease, potentially offering an alternative to the current standard treatment. This research could help improve the management of this rare eye condition and enhance the quality of life for those affected by it.

1 initial treatment phase

The study begins with the administration of an intravitreal injection of bevacizumab (Avastin®). This medication is injected directly into the eye to treat Coats’ disease.

The injection is given as a solution for infusion, specifically designed for use inside the eye.

2 follow-up and monitoring

After the initial treatment, the condition of the eye is monitored at regular intervals. Evaluations occur at 2, 4, 6, and 9 months after the start of the treatment.

These evaluations include checking for improvements in the disease stage, visual acuity, and other eye health indicators using various imaging techniques.

3 comparison of treatment outcomes

The study compares the effects of the bevacizumab injection with a reference treatment, which involves laser photocoagulation. This comparison helps determine the effectiveness of the injection.

The primary goal is to see if there is an improvement in the disease stage 6 months after treatment begins.

4 additional treatment assessment

If necessary, additional treatments may be considered. This could include more laser sessions or surgical interventions, depending on the patient’s response to the initial treatment.

The need for further treatment is assessed 9 months after the initial treatment.

5 final evaluation

The final evaluation of the treatment’s effectiveness and any side effects is conducted at the end of the study period.

This includes a comprehensive assessment of the eye’s condition and any changes in the disease stage.

Who Can Join the Study?

The patient must be 16 years old or younger.
The patient must have Coats’ disease, which is confirmed by a special eye exam called a fundus examination and a test called fluorescein angiography. This test uses a dye to look at the blood vessels in the eye.
The disease must be at Stage 2 or 3 according to a specific way of classifying the disease, known as the Shields classification.
The patient must not have received any previous treatment for the eye affected by Coats’ disease. This means the eye is naïve to any ocular treatment.
The patient must be a beneficiary of a Social Security scheme. This means they should be covered by a health insurance plan.
Both parents or guardians must provide free, informed, written consent for the patient to participate in the study. This means they agree to the study after understanding all the details.

Who Cannot Join the Study?

Patients who have any other eye disease besides Coats’ disease cannot participate. Coats’ disease is a rare eye condition that affects the blood vessels in the retina.
Patients who have had previous eye surgery or treatment for Coats’ disease are not eligible.
Patients with a history of severe allergic reactions to medications used in the study cannot join.
Patients with any serious health condition that might interfere with the study treatment are excluded.
Pregnant or breastfeeding women are not allowed to participate.
Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hopital Necker Enfants Malades	Paris	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Fondation A De Rothschild	Paris	France
Hopital NOVO	Pontoise	France
Cbrmtx Hpjqazhwoam Uvvntyrbeppbk Rjkip	Reims	France
Cowxdggl Rqzt Gwtmyq	Toulouse	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.10.2019

Trial locations

Investigated drugs:

Bevacizumab

Bevacizumab (Avastin) is a medication used in this trial as an initial and then additional treatment for Coats’ disease. It is given through an injection into the eye. Bevacizumab works by blocking a protein called VEGF, which can help reduce abnormal blood vessel growth and leakage in the eye, potentially improving vision or preventing further vision loss.

Laser Photocoagulation is a reference treatment used in this trial for Coats’ disease. This therapy involves using a laser to seal or destroy abnormal blood vessels in the eye. The goal is to prevent these vessels from leaking fluid or blood, which can help stabilize or improve vision.

Coats’ disease – Coats’ disease is a rare eye condition characterized by abnormal development of blood vessels in the retina, leading to leakage of blood and fluid. This leakage can cause retinal swelling and detachment, potentially affecting vision. The disease typically progresses through stages, starting with mild symptoms like small retinal telangiectasia and advancing to more severe stages with significant exudation and retinal detachment. It primarily affects young males and is usually unilateral, meaning it affects only one eye. As the disease progresses, it can lead to complications such as glaucoma or phthisis bulbi, where the eye becomes shrunken and non-functional. Early detection and monitoring are crucial to managing the progression and preserving vision.

Trial ID:

2024-517036-21-00

Protocol code:

FME_2018_9

NCT ID:

NCT03940690

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Bevacizumab Injections for Patients with Coats’ Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?