Clinical Trial: Topical Avastin for Treatment of Corneal Neovascularization

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization

Brief Summary: The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization.

Detailed Summary: Primary outcomes measures included neovascular area (NA), defined as the area of the corneal vessels themselves; vessel caliber (VC), defined as the mean diameter of the corneal vessels; and invasion area (IA), defined as the fraction of the total cornea into which the vessels extend. The occurrence of ocular and systemic adverse events was closely monitored throughout the course of the study.
Sponsor: Massachusetts Eye and Ear Infirmary

Current Primary Outcome:

  • The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study. [ Time Frame: Six Months ]
    The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.
  • Ocular and Systemic Safety [ Time Frame: All study visits ]
    The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.


Original Primary Outcome: The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study. [ Time Frame: Six Months ]

Current Secondary Outcome:

Original Secondary Outcome: Monitoring the safety of the treatment: comprehensive eye examination, BCVA, IOP, evaluation of the lid/lashes, conjunctiva, cornea, anterior chamber, iris/pupil, lens, vitreous, macula and optic nerve, querying and recording of adverse events. [ Time Frame: Six Months ]

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: November 14, 2007
Date Started: February 2007
Date Completion:
Last Updated: October 2, 2012
Last Verified: October 2012