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

Pterygium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02342392
• Other study ID #: 1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 14, 2015
• Last updated: January 14, 2015
• Start date: September 2012
• Est. completion date: September 2014

Study information

• Verified date: January 2015
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: National Medical Research Register
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium
• Recurrence

Intervention

Drug:
• ranibizumab
Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Science Malaysia

References & Publications (35)

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* Note: There are 35 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pterygium recurrence	pterygium recurrence is defined as true recurrence with a fibrovascular tissue invading the cornea (grade 4 lesion)	1 year	No
Secondary	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.	1 week	No
Secondary	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.	1 week	No