Effect of Bevacizumab Subconjunctival Injections on Corneal Newvessels
18 Years
N/A
Both
Corneal Newvessels
Trial Information
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.
Inclusion Criteria:
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
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 exception of herpes)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Neovascularisation reduction at 3 months
Outcome Description:
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.
Outcome Time Frame:
at 3 months
Safety Issue:
No
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
I07034
NCT ID:
NCT01501760
Start Date:
January 2012
Completion Date:
October 2014
Related Keywords:
- Corneal Newvessels
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