Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

Not Applicable

Completed

• Conditions: Pterygium of the Conjunctiva and Cornea
• Interventions: Drug: Bevacizumab; Drug: Fluorometholone

• Registration Number: NCT01288404
• Lead Sponsor: Ramathibodi Hospital

Brief Summary

Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.

Detailed Description

1. Impending recurrent pterygium

2. Anti-VEGF therapy

* Bevacizumab

* Subconjunctival injection

* Suppress neovascularization

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Status Verified: 2011-01
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-01
• Last Update Submitted: 2011-02-01
• Study First Posted: 2011-02-02
• Last Update Posted: 2011-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
2. Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
3. No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
4. No other ocular surface pathologies or coexisting ocular diseases.
5. No other ocular surgeries within the previous 6 months.
6. No history of allergy to the medications used in this study.
7. Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion Criteria

1. Platelet disorders
2. Hypertension
3. Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
bevacizumab group 3	Bevacizumab	bevacizumab 3.75 mg/0.15mL
Bevacizumab group 2	Bevacizumab	Bevacizumab 2.5 mg/0.1mL
Control	Fluorometholone	topical 0.1% fluorometholone eye drops
Bevacizumab group 1	Bevacizumab	Bevacizumab 1.25 mg/0.05mL

Primary Outcome Measures

Name	Time	Method
Severity of impending recurrent pterygium	3 months

Secondary Outcome Measures

Name	Time	Method
Visual analog scales	3 months
Adverse reactions	3 months

Trial Locations

Locations (1)

Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand