TREATMENT OF CORNEAL NEOVASCULARIZATIO

Phase 1

• Conditions: Corneal neovascularisation; MedDRA version: 14.0 Level: PT Classification code 10055665 Term: Corneal neovascularisation System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-022858-16-FR
• Lead Sponsor: CHU de Limoges

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-19
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

•Patients with corneal neovascularization whatever the origin
•Patient did not receive treatment with topical corticosteroids during the month preceding inclusion.
•Patient who has been properly informed and signed consent
•Patient aged over 18
•Patient affiliated with a health insurance plan or benefit of such a regime
- Negative pregnancy test for Women at inclusion

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

•Patients who received local or general treatment of concomitant prostaglandin derivatives
•Patients with current infection of the cornea or other tissue / organ
•Women of childbearing age without contraception
•Pregnancy and Lactation
•Patient participating in another study
•Patient with contact lenses
•Patients with uncontrolled hypertension
•Patient with a history of stroke, myocardial infarction, angina pectoris, thrombophlebitis, Raynaud's phenomenon.
•Patients hypersensitive to the active substance or any excipients
•Patients hypersensitive to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies.
•Patients with active bacterial eye infections, fungal, parasitic or viral infection (with the exeption of herpes)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate Bevacizumab subconjunctival injections effectiveness on corneal neovascularisation reduction after 3 monthly injections;<br> Secondary Objective: •The effectiveness of bevacizumab on reducing the percentage of corneal surface occupied by neovascularization at 6 months <br> •The effectiveness of bevacizumab on reducing the use of corneal graft. <br> •The local and general toxicity of bevacizumab administered by subconjunctival way.<br> <br> ;Primary end point(s): Reduction higher than 30 % of the corneal surface occupied by newvessels , at 3 months, in the Bevacizumab group compared to the placebo group.;Timepoint(s) of evaluation of this end point: - at 3 month (one month after the third injection)

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): •Reduction the percentage of corneal surface occupied by neovascularization at 6 months <br> •Reduction of the use of corneal graft<br> •Local and general toxicity of bevacizumab administered by subconjunctival way<br> ;Timepoint(s) of evaluation of this end point: -At 6 month (4 months after the third injection)