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

NCT03940690 | Terminated Phase 3

• 1 other identifier: FME_2018_9
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

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.

Conditions

Coats Disease; Retinal Telangiectasis

Keywords

Retinal Telangiectasis; Coats Disease; Anti-VEGF (Vascular Endothelial Growth Factor)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Anti-VEGF injections (bevacizumab)

EXPERIMENTAL

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

Arm : laser only

ACTIVE COMPARATOR

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

Device: Laser

Interventions

Anti-VEGF injections of bevacizumab DRUG

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)

Anti-VEGF injections (bevacizumab)

Laser DEVICE

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

Arm : laser only

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (6)

Centre hospitalier René Dubos (Pontoise)

Cergy-Pontoise, France, 95303, France

Location

Hôpital Universitaire Necker Enfants Malades, APHP

Paris, France, 75015, France

Location

Fondation Ophtalmologique A. de Rothschild

Paris, France, 75019, France

Location

CHU de Reims

Reims, France, 51092, France

Location

Clinique Rive Gauche

Toulouse, France, 31000, France

Location

CHU de Bordeaux

Bourdeaux, 33076, France

Location

MeSH Terms

Conditions

Retinal Telangiectasis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Telangiectasis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Florence METGE

  fmetge@for.paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2019
• First Posted: May 7, 2019
• Study Start: October 24, 2019
• Primary Completion: June 6, 2023
• Study Completion: October 13, 2023
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (6)