Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia
Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.|
- Safety [ Time Frame: Within the first 30 days after injection ] [ Designated as safety issue: Yes ]The following safety criteria will be monitored: subjective complaints, objective signs of inflammation, intraocular pressure, tear film and ocular surface integrity.
- Regression of pterygium [ Time Frame: Within 30 days after drug injection ] [ Designated as safety issue: No ]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
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
Experimental: Ranibizumab treatment
Patients will receive a sub-tenons injection of Ranibizumab 0.5mg, to be repeated twice with 30 day intervals between each dose.
Subtenon injections of Ranibizumab 0.5mg will be given, and repeated twice with 30 day intervals between each dose. Note, after an amendment in February 2011, this dose was increased to 2mg with the same schedule.
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.
|Contact: Linda Rose, MDfirstname.lastname@example.org|
|Contact: Arup Das, MDemail@example.com|
|United States, New Mexico|
|University of New Mexico Health Science Center||Recruiting|
|Albuquerque, New Mexico, United States, 87106|
|Principal Investigator: Linda Rose, MD PhD|