Clinical trial NCT03940690: Interest of Intravitreal Injections of Anti-VEGF As Initial and Adjuvant Treatment in Coats Disease
Official title: Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF As Initial and Adjuvant Treatment in Coats Disease
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Retinal Telangiectasis
Coats Disease
Keywords: Retinal Telangiectasis
Coats Disease
Anti-VEGF (Vascular Endothelial Growth Factor)
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-07
Enrollment: 30
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients with improvement of stage of disease, according to the Shields classification
timeFrame: 6 months after randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Cergy-Pontoise
country: France
facility: Centre hospitalier René Dubos (Pontoise)
city: Paris
country: France
facility: Hôpital Universitaire Necker Enfants Malades, APHP
city: Paris
country: France
facility: Fondation Ophtalmologique A. de Rothschild
city: Reims
country: France
facility: CHU de Reims
city: Toulouse
country: France
facility: Clinique Rive Gauche
Study officials:
affiliation: fmetge@for.paris
name: Florence METGE
role: PRINCIPAL_INVESTIGATOR
References: