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

Coats Disease Clinical Trial

— COATS-VEGF  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03940690
• Other study ID #: FME_2018_9
• Status: Suspended
• Phase: Phase 3
• Start date: October 24, 2019
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Coats Disease
• Retinal Telangiectasis
• Telangiectasis

Intervention

Drug:
• Anti-VEGF injections of bevacizumab
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)

Device:
• Laser
3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9

Locations

Country	Name	City	State
France	Centre hospitalier René Dubos (Pontoise)	Cergy-Pontoise
France	Fondation Ophtalmologique A. de Rothschild	Paris
France	Hôpital Universitaire Necker Enfants Malades, APHP	Paris
France	CHU de Reims	Reims
France	Clinique Rive Gauche	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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