Bevacizumab for Primary Pterygium Treatment

Phase 1

Completed

• Conditions: Pterygium
• Interventions: Procedure: Autoconjunctival grafting; Drug: Subconjuntival bevacizumab injection

• Registration Number: NCT01686529
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Brief Summary

The aim of this study was to investigate the efficacy and safety of subconjunctival bevacizumab application as an adjuvant therapy for primary pterygium.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-02
• Study Completion: 2012-02
• Study First Submitted: 2012-09-11
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-18
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Patients with primary pterygium

Exclusion Criteria

• Patients with diabetes mellitus
• collagenopathies,
• previous ocular surgeries,
• pregnant or lactating patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
One subconjunctival injection	Autoconjunctival grafting	Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery
One subconjunctival injection	Subconjuntival bevacizumab injection	Autoconjunctival grafting and one subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery
Two subconjuctival injections	Autoconjunctival grafting	Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery
Two subconjuctival injections	Subconjuntival bevacizumab injection	Autoconjunctival grafting and subconjuntival bevacizumab injection (2.5mg/0.1ml) was applied after surgery, with another injection 15 days after surgery
Conventional treatment	Autoconjunctival grafting	Autoconjunctival grafting without subconjuntival bevacizumab injection

Primary Outcome Measures

Name	Time	Method
Pterygium recurrence	One point.	The pterygium recurrence is evaluated at one year postoperative

Secondary Outcome Measures

Name	Time	Method
Conjunctival ischemia	Ischemia is measured at 24 h, 1 week, 15 days, six months and one year postoperative	Whiteness of conjunctival bed, that means absence of blood vessels

Trial Locations

Locations (1)

Instituto de Oftalmología; 🇲🇽 Mexico City, Mexico