Efficacy and Safety Study of Avastin to Treat Neovascularisation of the Cornea (BECONNEC)
Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to reduce newascularization induced by gastric cancer or age-related macular degeneration. A few reports have been published showing the interest of VEGF inhibitors to treat corneal newvessels, but no randomized study has been achieved to date.
This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal antibody, to reduce the surface of corneal newvessels in when compared to placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Bevacizumab Subconjunctival Injections on Corneal Newvessels|
- Neovascularisation reduction at 3 months [ Time Frame: at 3 months ] [ Designated as safety issue: No ]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.
- Local and general toxicity of bevacizumab [ Time Frame: at 1 months, 2 month, 3 month, 6 month ] [ Designated as safety issue: Yes ]Safty data are collected at each visit either by clinical examination or by patient questionnary
- Efficacy at 6 months [ Time Frame: at 6 month ] [ Designated as safety issue: No ]Assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 6 month
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month.
Three subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month
Placebo Comparator: Placebo
Three subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month.
Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501760
|Contact: Pierre Yves ROBERT, MDfirstname.lastname@example.org|
|Limoges, France, 87042|
|Contact: Pierre Yves ROBERT, MD 05 55 05 62 08 email@example.com|
|Principal Investigator: Pierre Yves ROBERT, MD|
|Sub-Investigator: Yohan BENAYOUN, MD|
|Poitiers, France, 86021|
|Contact: Nicolas LEVEZIEL, MD 05 49 44 41 82 firstname.lastname@example.org|
|Principal Investigator: Nicolas LEVEZIEL, MD|
|CHU Strasbourg- Service Ophtalmlogie||Recruiting|
|Strasbourg, France, 67000|
|Contact: Tristan BOURCIER, MD 03 69 55 11 16 email@example.com|
|Contact: Jonathan LETSCH, MD 03 69 55 04 52 firstname.lastname@example.org|
|Principal Investigator: Tristan BOURCIER, MD|
|Sub-Investigator: Jonathan LETSCH, MD|
|CHU de Toulouse, Service d'Ophtalmologie||Recruiting|
|Toulouse, France, 31059|
|Contact: Pierre FOURNIE, MD 05-61-77-21-61 email@example.com|
|Principal Investigator: Pierre Fournie, MD|