Informations générales (source: ClinicalTrials.gov)
Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease (COATS-VEGF)
Interventional
Phase 3
Fondation Ophtalmologique Adolphe de Rothschild (Voir sur ClinicalTrials)
octobre 2019
novembre 2024
19 octobre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FONDATION A. DE ROTHSCHILD | Florence METGE | 21/06/2024 13:32:55 | Contacter | ||
| HOPITAL NOVO | PASQUIER | 04/07/2024 11:04:56 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Necker-Enfants Malades | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Reims - 51092 - Reims - France | Contact (sur clinicalTrials) | ||||
| Clinique Rive Gauche - 31000 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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