Efficacy and Safety Study of Avastin to Treat Neovascularisation of the Cornea

Phase 3

Completed

• Conditions: Corneal Newvessels
• Interventions: Drug: NaCl; Drug: bevacizumab

• Registration Number: NCT01501760
• Lead Sponsor: University Hospital, Limoges

Brief Summary

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

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 Timeline

• Study First Submitted: 2011-12-26
• Study First Submitted QC: 2011-12-28
• Study First Posted: 2011-12-29
• Study Start: 2012-05-13
• Status Verified: 2018-10
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NaCl	Three subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month.
bevacizumab	bevacizumab	Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month.

Primary Outcome Measures

Name	Time	Method
Neovascularisation reduction at 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Local and general toxicity of bevacizumab	at 1 months, 2 month, 3 month, 6 month	Safty data are collected at each visit either by clinical examination or by patient questionnary
Efficacy at 6 months	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

Trial Locations

Locations (5)

CHU St Etienne; 🇫🇷 Saint-Étienne, France

CHU Strasbourg- Service Ophtalmlogie; 🇫🇷 Strasbourg, France

Service d'Ophtalmologie; 🇫🇷 Limoges, France

CHU Poitiers-Ophtalmologie; 🇫🇷 Poitiers, France

CHU de Toulouse, Service d'Ophtalmologie; 🇫🇷 Toulouse, France