Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

February 1, 2011 updated by: Ramathibodi Hospital

A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. Impending recurrent pterygium

  2. Anti-VEGF therapy

    • Bevacizumab
    • Subconjunctival injection
    • Suppress neovascularization

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
topical 0.1% fluorometholone eye drops
Drug: Fluorometholone
topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks
Other Names:
  • FML eye drops
Active Comparator: Bevacizumab group 1
Bevacizumab 1.25 mg/0.05mL
Drug: Bevacizumab
subconjunctival bevacizumab 1.25 mg/0.05mL
Other Names:
  • Avastin
Drug: Bevacizumab
subconjunctival bevacizumab 2.5 mg/0.1mL
Other Names:
  • Avastin
Drug: Bevacizumab
subconjunctival bevacizumab 3.75 mg/0.15mL
Other Names:
  • Avastin
Active Comparator: Bevacizumab group 2
Bevacizumab 2.5 mg/0.1mL
Drug: Bevacizumab
subconjunctival bevacizumab 1.25 mg/0.05mL
Other Names:
  • Avastin
Drug: Bevacizumab
subconjunctival bevacizumab 2.5 mg/0.1mL
Other Names:
  • Avastin
Drug: Bevacizumab
subconjunctival bevacizumab 3.75 mg/0.15mL
Other Names:
  • Avastin
Active Comparator: bevacizumab group 3
bevacizumab 3.75 mg/0.15mL
Drug: Bevacizumab
subconjunctival bevacizumab 1.25 mg/0.05mL
Other Names:
  • Avastin
Drug: Bevacizumab
subconjunctival bevacizumab 2.5 mg/0.1mL
Other Names:
  • Avastin
Drug: Bevacizumab
subconjunctival bevacizumab 3.75 mg/0.15mL
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity of impending recurrent pterygium
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Visual analog scales
Time Frame: 3 months
3 months
Adverse reactions
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Kaevalin Lekhanont, MD, Ramathibodi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 1, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

February 2, 2011

Last Update Submitted That Met QC Criteria

February 1, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 055217

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pterygium of the Conjunctiva and Cornea

Clinical Trials on Fluorometholone

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe