Clinical Trial: Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia

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

Official Title: The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.

Brief Summary: Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.

Detailed Summary:

Ptergyia are chronic fibrovascular lesions of the ocular surface. This study is designed to look for a signal of efficacy when the lesions are in a phase of active vascular growth. This phase is most often caught in a newly recurring pterygia post-operatively.

Patients identified with actively growing lesions, will be offered local injections directly beneath the lesions. They will be examined for any adverse side effects and regression of the lesion.


Sponsor: University of New Mexico

Current Primary Outcome: Safety [ Time Frame: Within the first 30 days after injection ]

The following safety criteria will be monitored: subjective complaints, objective signs of inflammation, intraocular pressure, tear film and ocular surface integrity.


Original Primary Outcome: Same as current

Current Secondary Outcome: Regression of pterygium [ Time Frame: Within 30 days after drug injection ]

Regression of the lesion will be determined by measurement if the horizontal extension of the lesion relative to the limbus, and by photographic comparison incorporating software analysis


Original Secondary Outcome: Same as current

Information By: University of New Mexico

Dates:
Date Received: July 23, 2010
Date Started: August 2010
Date Completion:
Last Updated: May 13, 2016
Last Verified: May 2016