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

October 23, 2019 updated by: University Hospital, Limoges

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Limoges, France, 87042
        • Service d'Ophtalmologie
      • Poitiers, France, 86021
        • CHU Poitiers-Ophtalmologie
      • Saint-Étienne, France
        • CHU ST Etienne
      • Strasbourg, France, 67000
        • CHU Strasbourg- Service Ophtalmlogie
      • Toulouse, France, 31059
        • CHU de Toulouse, Service d'Ophtalmologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bevacizumab
Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month.
Drug: bevacizumab
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.
Drug: NaCl
Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neovascularisation reduction at 3 months
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local and general toxicity of bevacizumab
Time Frame: at 1 months, 2 month, 3 month, 6 month
Safty data are collected at each visit either by clinical examination or by patient questionnary
at 1 months, 2 month, 3 month, 6 month
Efficacy at 6 months
Time Frame: at 6 month
Assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 6 month
at 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Limoges

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2012

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

December 26, 2011

First Submitted That Met QC Criteria

December 28, 2011

First Posted (Estimate)

December 29, 2011

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I07034

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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