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

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

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.

Study Overview

• Status: Suspended
• Conditions: Retinal Telangiectasis; Coats Disease
• Intervention / Treatment: Drug: Anti-VEGF injections of bevacizumab; Device: Laser

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Cergy-Pontoise, France, 95303
    • Centre hospitalier René Dubos (Pontoise)
  • Paris, France, 75019
    • Fondation Ophtalmologique A. de Rothschild
  • Paris, France, 75015
    • Hôpital Universitaire Necker Enfants Malades, APHP
  • Reims, France, 51092
    • CHU de Reims
  • Toulouse, France, 31000
    • Clinique Rive Gauche

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anti-VEGF injections (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	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)
Active Comparator: Arm : laser only; 3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Florence METGE, fmetge@for.paris

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2019
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: May 6, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Anti-VEGF (Vascular Endothelial Growth Factor); Retinal Telangiectasis; Coats Disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Telangiectasis; Retinal Telangiectasis; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: FME_2018_9

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No