Clinical trial NCT02342392: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pterygium
Keywords: pterygium
ranibizumab
anti-VEGF
recurrence
vascularity
size
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: pterygium recurrence
timeFrame: 1 year
Secondary outcomes:
measure: pterygium vessel area
timeFrame: 1 week
measure: corneal pterygium area
timeFrame: 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universiti Sains Malaysia
name: Hao Chi Ho, MD
role: PRINCIPAL_INVESTIGATOR
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