Effect of Bevacizumab Subconjunctival Injections on Corneal Newvessels
This study will involve 42 outpatients of the CHU of Limoges, Bordeaux, and Toulouse,
addressed for corneal pathologies including corneal newvessels. The patients will be
randomly assigned to two groups, one receiving three subconjunctival injections of
bevacizumab, the other three subconjunctival injections of placebo (Balanced salt solution).
The progression of newvessels will be assessed using color photographs and a
picture-analyser software that will calculate the percentage of corneal surface occupied by
the newvessels. Randomization, and preparation of both study drug and placebo syringes will
be performed by the central pharmacy of the CHU de Limoges. Patients will be followed-up as
outpatients, with visits scheduled 15 days before treatment, at baseline, and then at 1
month, 2 months, 3 months, and 6 months.
- Primary outcome: To demonstrate Bevacizumab subconjunctival injections effectiveness on
corneal neovascularisation reduction definite by a superior percentage of patient with
a reduction higher than 30 % of the corneal surface occupied by newvessels , at 3
months, in the group Bevacizumab compared with the group placebo
- Secondary outcomes:
- The effectiveness of bevacizumab on reducing the percentage of corneal surface occupied
by neovascularization at 6 months
- The effectiveness of bevacizumab on reducing the use of corneal graft.
- The local and general toxicity of bevacizumab administered by subconjunctival way.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Neovascularisation reduction at 3 months
Assessement using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 3 months. A reduction of 30% is target.
at 3 months
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)