Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease

Study Overview
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Brief Summary
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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.

Official Title
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Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease

Conditions
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Retinal Telangiectasis, Coats Disease

Intervention / Treatment
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* Drug: Anti-VEGF injections of bevacizumab
* Device: Laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-VEGF injections (bevacizumab)<br>5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9 | Drug: Anti-VEGF injections of bevacizumab<br>* 5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9)<br>|
| Active Comparator: Arm : laser only<br>3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9 | Device: Laser<br>* 3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with improvement of stage of disease, according to the Shields classification | Stages assessed by retinal multimodal imaging (retinophotography, optical coherence tomography when age allows, retinal fluorescein angiography) by two independent expert ophthalmologists | 6 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retinal Telangiectasis, Coats Disease, Anti-VEGF (Vascular Endothelial Growth Factor)