Pterygium
Conditions
Keywords
Pterygium
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.
Interventions
DRUGRanibizumab
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.
Sponsors
Genentech, Inc.
University of New Mexico
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patients with actively growing pterygia, either surgical recurrences, or non-surgical primary lesions.
Exclusion criteria
* Pregnancy * History of CVA * Monocular patients * Minors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed