Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study
Primary Purpose
Pterygium
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Pterygium focused on measuring pterygium, ranibizumab, anti-VEGF, recurrence, vascularity, size
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
treatment group
control group
Arm Description
intralesional ranibizumab injected
no intralesional ranibizumab injected.
Outcomes
Primary Outcome Measures
pterygium recurrence
pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion)
Secondary Outcome Measures
pterygium vessel area
Pterygium vesel area is defined as the as the ration of pixels occupied by the vessels within the pterygium area in percentage.
corneal pterygium area
Corneal pterygium area is defined as the as the ration of pixels occupied by the pterygium within the cornea area in percentage.
Full Information
NCT ID
NCT02342392
First Posted
January 14, 2015
Last Updated
January 14, 2015
Sponsor
Universiti Sains Malaysia
1. Study Identification
Unique Protocol Identification Number
NCT02342392
Brief Title
Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study
Official Title
Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Sains Malaysia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
The purpose of this study is to:
Compare the vascularity of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.
Compare the size of primary pterygium before and 1 week after intralesional ranibizumab (0.3 mg/0.03 mL) injection.
Compare the recurrence rate at 1 year after pterygium excision surgery between the group with and without intralesional ranibizumab injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
pterygium, ranibizumab, anti-VEGF, recurrence, vascularity, size
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Active Comparator
Arm Description
intralesional ranibizumab injected
Arm Title
control group
Arm Type
No Intervention
Arm Description
no intralesional ranibizumab injected.
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Description
Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.
Primary Outcome Measure Information:
Title
pterygium recurrence
Description
pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
pterygium vessel area
Description
Pterygium vesel area is defined as the as the ration of pixels occupied by the vessels within the pterygium area in percentage.
Time Frame
1 week
Title
corneal pterygium area
Description
Corneal pterygium area is defined as the as the ration of pixels occupied by the pterygium within the cornea area in percentage.
Time Frame
1 week
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hao Chi Ho, MD
Organizational Affiliation
Hospital Universiti Sains Malaysia
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study
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