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

January 14, 2015 updated by: Hao Chi Ho, Universiti Sains Malaysia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 3

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:

  • 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 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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: treatment group
intralesional ranibizumab injected
Drug: ranibizumab
Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.
Other Names:
  • Lucentis
No Intervention: control group
no intralesional ranibizumab injected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pterygium recurrence
Time Frame: 1 year
pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion)
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pterygium vessel area
Time Frame: 1 week
Pterygium vesel area is defined as the as the ration of pixels occupied by the vessels within the pterygium area in percentage.
1 week
corneal pterygium area
Time Frame: 1 week
Corneal pterygium area is defined as the as the ration of pixels occupied by the pterygium within the cornea area in percentage.
1 week

Collaborators and Investigators

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

Sponsor

Universiti Sains Malaysia

Investigators

  • Principal Investigator: Hao Chi Ho, MD, Hospital Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

January 14, 2015

First Submitted That Met QC Criteria

January 14, 2015

First Posted (Estimate)

January 19, 2015

Study Record Updates

Last Update Posted (Estimate)

January 19, 2015

Last Update Submitted That Met QC Criteria

January 14, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

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.

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