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Multicenter randomized controlled trial of the value of intravitreal anti-VEGF injections as initial then adjuvant treatment in Coats' disease
EU CTIS ID: 2024-517036-21-00
What this study is testing
To compare the efficacy of treatment with intravitreal (IVT) injection of anti-VEGF (bevacizumab, Avastin®) on the stage of Coats' disease, versus reference treatment with laser photocoagulation, 6 months after initiation of study treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patient ≤ 16 years
- Coats disease confirmed by fundus examination and fluorescein angiography
- Stages 2 or 3 on fundus examination (Shields classification)
- Naïve to any ocular treatment on the eye affected by Coats' disease
- Beneficiary of a Social Security scheme
- Free, informed, written consent of both holders of parental authority
You likely can't join if
- Other ocular pathology on the eye affected by Coats' disease
- Pregnancy or breastfeeding
- Bilateral forms of the disease
- History of hypersensitivity to bevacizumab
- History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or to other human or humanized recombinant antibodies
- Allergic reaction to previous fluorescein retinal angiography
See the full eligibility criteria
- Patient ≤ 16 years
- Coats disease confirmed by fundus examination and fluorescein angiography
- Stages 2 or 3 on fundus examination (Shields classification)
- Naïve to any ocular treatment on the eye affected by Coats' disease
- Beneficiary of a Social Security scheme
- Free, informed, written consent of both holders of parental authority
- Other ocular pathology on the eye affected by Coats' disease
- Pregnancy or breastfeeding
- Bilateral forms of the disease
- History of hypersensitivity to bevacizumab
- History of hypersensitivity to Chinese Hamster Ovary (CHO) cell products or to other human or humanized recombinant antibodies
- Allergic reaction to previous fluorescein retinal angiography
- Active or suspected periocular infection
- Contraindication to treatments used for general anesthesia (Propofol, halogenated gases (Sevoflurane) and morphine derivatives (Sufentanil))
- Cardiovascular, hemorrhagic and gastrointestinal risks
- Premature infant under 37 weeks corrected age
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.