EUCTR2018-003863-67-FR
Active, not recruiting
Phase 1
Multicenter randomized controlled trial on the interest of intravitreal injections of anti-VEGF as initial and adjuvant treatment in Coats disease - COATS-VEGF
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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