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

Conditions

• Corneal Newvessels

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — DRUG
  Three subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month
• NaCl — DRUG
  Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month

Study Details

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

Key Dates

First listed

Dec 29, 2011

Start date

May 13, 2012

Status verified

Oct 2018

Primary completion

Oct 31, 2019

Completion

Oct 31, 2019

Study Design

Enrollment

38 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.

Primary Outcome Measure

Neovascularisation reduction at 3 months [ Time Frame: at 3 months ]