Multicenter randomized controlled trial on the interest of intravitreal injections of anti-VEGF as initial and adjuvant treatment in Coats disease

Phase 1

• Conditions: Coats disease; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-003863-67-FR
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-28
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: A
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- Patient = 16 years old
- Coats disease confirmed by fundus examination and fluorescein angiography
- Stage 2 or 3 at the fundus (Shields classification) on at least 2 quadrants
- Naïve to any eye treatment on the eye affected by Coats disease

Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified