Efficacy and Safety Study of Avastin to Treat Neovascularisation of the Cornea (BECONNEC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01501760
First received: December 26, 2011
Last updated: April 5, 2014
Last verified: April 2014

December 26, 2011
April 5, 2014
January 2012
April 2015   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01501760 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Avastin to Treat Neovascularisation of the Cornea
Effect of Bevacizumab Subconjunctival Injections on Corneal Newvessels

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Corneal Newvessels
  • Drug: bevacizumab
    Three subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month
  • Drug: NaCl
    Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month
  • Experimental: bevacizumab
    Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month.
    Intervention: Drug: bevacizumab
  • Placebo Comparator: Placebo
    Three subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month.
    Intervention: Drug: NaCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
April 2016
April 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Pierre Yves ROBERT, MD pierre-yves.robert@unilim.fr
France
 
NCT01501760
I07034
Yes
University Hospital, Limoges
University Hospital, Limoges
Not Provided
Not Provided
University Hospital, Limoges
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP