Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

NCT ID: NCT01288404

Last Updated: 2011-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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1. Impending recurrent pterygium
2. Anti-VEGF therapy

* Bevacizumab
* Subconjunctival injection
* Suppress neovascularization

Conditions

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Pterygium of the Conjunctiva and Cornea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

topical 0.1% fluorometholone eye drops

Group Type PLACEBO_COMPARATOR

Fluorometholone

Intervention Type DRUG

topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks

Bevacizumab group 1

Bevacizumab 1.25 mg/0.05mL

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

subconjunctival bevacizumab 1.25 mg/0.05mL

Bevacizumab group 2

Bevacizumab 2.5 mg/0.1mL

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

subconjunctival bevacizumab 2.5 mg/0.1mL

bevacizumab group 3

bevacizumab 3.75 mg/0.15mL

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

subconjunctival bevacizumab 3.75 mg/0.15mL

Interventions

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Fluorometholone

topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks

Intervention Type DRUG

Bevacizumab

subconjunctival bevacizumab 1.25 mg/0.05mL

Intervention Type DRUG

Bevacizumab

subconjunctival bevacizumab 2.5 mg/0.1mL

Intervention Type DRUG

Bevacizumab

subconjunctival bevacizumab 3.75 mg/0.15mL

Intervention Type DRUG

Other Intervention Names

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FML eye drops Avastin Avastin Avastin

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ramathibodi Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ramathibodi Hospital

Principal Investigators

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Kaevalin Lekhanont, MD

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital

Locations

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Ramathibodi Hospital

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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055217

Identifier Type: -

Identifier Source: org_study_id

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