Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia
|ClinicalTrials.gov Identifier: NCT01169909|
Recruitment Status : Completed
First Posted : July 26, 2010
Last Update Posted : May 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pterygium||Drug: Ranibizumab||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Ranibizumab to Control Pterygium Growth in Recurrences and in Non-surgical Primary Lesions.|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169909
|United States, New Mexico|
|University of New Mexico Health Science Center|
|Albuquerque, New Mexico, United States, 87106|