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

  • STATUS
    Recruiting
  • End date
    Nov 23, 2024
  • participants needed
    30
  • sponsor
    Fondation Ophtalmologique Adolphe de Rothschild
Updated on 12 February 2022

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.

Details
Condition Retinal Telangiectasis, Coats Disease
Treatment Laser, Anti-VEGF injections of bevacizumab
Clinical Study IdentifierNCT03940690
SponsorFondation Ophtalmologique Adolphe de Rothschild
Last Modified on12 February 2022

Eligibility

Yes No Not Sure

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
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