Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study

Phase 2

Completed

• Conditions: Pterygium
• Interventions: Drug: ranibizumab

• Registration Number: NCT02342392
• Lead Sponsor: Universiti Sains Malaysia

Brief Summary

The purpose of this study is to evaluate the pterygium vascularity and size before and after intralesional ranibizumab injection and to evaluate its recurrence rate following pterygium excision surgery.

Detailed Description

The purpose of this study is to:

1. Compare the vascularity of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.

2. Compare the size of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.

3. Compare the recurrence rate at 1 year after pterygium excision surgery between the group with and without intralesional ranibizumab injection.

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-01-14
• Last Update Submitted: 2015-01-14
• Study First Posted: 2015-01-19
• Last Update Posted: 2015-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• All patients with primary pterygium.
• Grade T3 (fleshy) pterygium.

Exclusion Criteria

• Patients with other ocular surface disorders.
• Previous ocular surgery or trauma.
• History of systemic thromboembolic event.
• Pregnant women and lactating mother.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment group	ranibizumab	intralesional ranibizumab injected

Primary Outcome Measures

Name	Time	Method
pterygium recurrence	1 year	pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion)

Secondary Outcome Measures

Name	Time	Method
pterygium vessel area	1 week	Pterygium vesel area is defined as the as the ration of pixels occupied by the vessels within the pterygium area in percentage.
corneal pterygium area	1 week	Corneal pterygium area is defined as the as the ration of pixels occupied by the pterygium within the cornea area in percentage.