CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Bevacizumab +1 moredrug
Likely dose
Bevacizumab 1.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01115517
NCT01115517Phase 2Completed

A Pilot Study to Assess Safety and Efficacy of Intraoperative Topical Mitomycin C and Bevacizumab (Avastin) Applied to Bare Sclera in Pterygium Surgery

The University of Texas Health Science Center, Houston·interventional·Posted May 4, 2010·Updated Oct 21, 2016

In Brief

A Phase 2 clinical trial evaluating Bevacizumab and Mitomycin C for Pterygium. Completed, enrolled 51 participants across 2 sites.

Detailed Summary

This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPterygium
CountriesUnited States
CollaboratorsHermann Eye Center

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 4, 2010
Enrollment StartOct 1, 2010
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 16.2 years ago

Interventions

Bevacizumabdrug

1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.

Mitomycin Cdrug

Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.