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

Conditions

• Coats Disease
• Retinal Telangiectasis

Eligibility Criteria

Sex

ALL

Age

N/A - 16 Years

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

First listed

May 7, 2019

Start date

Oct 24, 2019

Status verified

Dec 2025

Primary completion

Jun 6, 2023

Completion

Oct 13, 2023

Study Design

Enrollment

18 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• 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

Primary Outcome Measure

Proportion of patients with improvement of stage of disease, according to the Shields classification [ Time Frame: 6 months after randomization ]