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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
Universiti Sains Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring pterygium, ranibizumab, anti-VEGF, recurrence, vascularity, size

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    January 14, 2015
    Last Updated
    January 14, 2015
    Sponsor
    Universiti Sains Malaysia
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    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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