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

Who is this study for? Patients with Retinal Telangiectasis, Coats Disease
Status: Terminated
Location: See all (6) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Maximum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Bordeaux
Bourdeaux
Centre hospitalier René Dubos (Pontoise)
Cergy-pontoise
Fondation Ophtalmologique A. de Rothschild
Paris
Hôpital Universitaire Necker Enfants Malades, APHP
Paris
CHU de Reims
Reims
Clinique Rive Gauche
Toulouse
Time Frame
Start Date: 2019-10-24
Completion Date: 2023-10-13
Participants
Target number of participants: 18
Treatments
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
Sponsors
Leads: Fondation Ophtalmologique Adolphe de Rothschild

This content was sourced from clinicaltrials.gov