Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease (NCT03940690) | Clinical Trial Compass
TerminatedPhase 3
Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease
Stopped: Study futility based on the interim analysis
France18 participantsStarted 2019-10-24
Plain-language summary
Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.
The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Coats disease confirmed by fundus examination and fluorescein angiography
* Stage 2 or 3 at the fundus (Shields classification)
* Naive to any eye treatment on the eye affected by Coats disease
Exclusion Criteria:
* Other ocular pathology on the eye affected by Coats' disease
* Bilateral forms of the disease
* History of hypersensitivity to bevacizumab
* History of hypersensitivity to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies
* Allergic reaction in a previous fluorescein retinal angiogram
* Pregnancy or breastfeeding
* Active or suspected periocular infection
* Contraindication to treatments used for general anesthesia and morphine derivatives
* Cardiovascular, haemorrhagic and gastrointestinal risks
* Premature baby who has not reached the correct age of 37 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with improvement of stage of disease, according to the Shields classification
Timeframe: 6 months after randomization
Trial details
NCT IDNCT03940690
SponsorFondation Ophtalmologique Adolphe de Rothschild