Exudative retinopathy Trials in Disease

Study on Bevacizumab Injections for Patients with Coats' Disease

This clinical trial is investigating a treatment for Coats' disease, a rare eye condition that affects the blood vessels in the retina, the light-sensitive layer at the back of the eye. The study is comparing the effectiveness of bevacizumab (marketed as Avastin) given through injections directly into the eye with the standard treatment of laser photocoagulation, which uses a laser to seal off abnormal blood vessels.

Who can participate:

• Children and teenagers who are 16 years old or younger
• Those who have confirmed Coats' disease at Stage 2 or 3 according to the Shields classification
• Patients whose affected eye has not received any previous treatment
• Those covered by a social security health insurance plan
• Parents or guardians must provide written consent after being fully informed about the study

Who cannot participate:

• Patients with any other eye disease besides Coats' disease
• Those who have had previous eye surgery or treatment for the condition
• Patients with a history of severe allergic reactions to the study medications
• Those with serious health conditions that might interfere with the treatment
• Pregnant or breastfeeding women
• Patients unable to follow study procedures or attend regular follow-up visits

What the trial involves:

The main goal of this study is to determine whether bevacizumab injections can improve the condition of the eye by at least one stage over a six-month period. Participants will receive either the Avastin injection or the standard laser treatment, and their progress will be monitored regularly at 2, 4, 6, and 9 months after starting treatment. During these visits, doctors will check for improvements in the disease stage, changes in vision, and the overall health of the eye using various imaging techniques.

Investigational drugs:

The trial is testing bevacizumab (Avastin), a medication that works by blocking a protein called VEGF. This protein is involved in the growth of abnormal blood vessels, and blocking it can help reduce leakage and potentially improve or preserve vision. The medication is given as an injection directly into the eye.

The comparison treatment is laser photocoagulation, which uses laser energy to seal or destroy abnormal blood vessels in the eye, preventing them from leaking fluid or blood and helping to stabilize or improve vision.

If necessary, additional treatments may be considered during the study, including more laser sessions or surgical interventions, depending on how each patient responds to the initial treatment. The final evaluation of treatment effectiveness and any side effects will be conducted at the end of the study period.