Efficacy and Safety of Sub-tenon Ranibizumab for Recurrent Pterygia
- Registration Number
- NCT01169909
- Lead Sponsor
- University of New Mexico
- Brief Summary
Ranibizumab, an effective antineovascular drug, will be studied for safety and efficacy in pterygium, a neovascular disorder of the ocular surface.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.
- Pregnancy
- History of CVA
- Monocular patients
- Minors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ranibizumab treatment Ranibizumab Patients will receive a sub-tenons injection of Ranibizumab 0.5mg, to be repeated twice with 30 day intervals between each dose.
- Primary Outcome Measures
Name Time Method Safety 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.
- Secondary Outcome Measures
Name Time Method Regression of pterygium 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
Trial Locations
- Locations (1)
University of New Mexico Health Science Center
🇺🇸Albuquerque, New Mexico, United States