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

This study is currently recruiting participants.
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
  Purpose

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


Condition Intervention Phase
Corneal Newvessels
Drug: bevacizumab
Drug: NaCl
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 48
Study Start Date: January 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01501760

Contacts
Contact: Pierre Yves ROBERT, MD pierre-yves.robert@unilim.fr

Locations
France
Service d'Ophtalmologie Recruiting
Limoges, France, 87042
Contact: Pierre Yves ROBERT, MD    05 55 05 62 08    pierre-yves.robert@unilim.fr   
Principal Investigator: Pierre Yves ROBERT, MD         
Sub-Investigator: Yohan BENAYOUN, MD         
CHU Poitiers-Ophtalmologie Recruiting
Poitiers, France, 86021
Contact: Nicolas LEVEZIEL, MD    05 49 44 41 82    nicolas.leveziel@chu-poitiers.fr   
Principal Investigator: Nicolas LEVEZIEL, MD         
CHU Strasbourg- Service Ophtalmlogie Recruiting
Strasbourg, France, 67000
Contact: Tristan BOURCIER, MD    03 69 55 11 16    tristan.bourcier@chru-strasbourg.fr   
Contact: Jonathan LETSCH, MD    03 69 55 04 52    jonathan.letsch@chru-strasbourg.fr   
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    fournie.p@chu-toulouse.fr   
Principal Investigator: Pierre Fournie, MD         
Sponsors and Collaborators
University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01501760     History of Changes
Other Study ID Numbers: I07034
Study First Received: December 26, 2011
Last Updated: April 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014