NCT02342392CompletedPhase 2
Intralesional Ranibizumab on Pterygium Vascularity, Size and Recurrence Rate: a Pilot Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Universiti Sains Malaysia
- Enrollment
- 36
- Primary Endpoint
- pterygium recurrence
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
treatment group
Active Comparator
intralesional ranibizumab injected
Intervention: ranibizumab (Drug)
Outcomes
Primary Outcomes
pterygium recurrence
Time Frame: 1 year
pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion)
Secondary Outcomes
- pterygium vessel area(1 week)
- corneal pterygium area(1 week)
Investigators
Hao Chi Ho
DR.
Universiti Sains Malaysia
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