Subconjunctival Bevacizumab and Recurrent Pterygium

Recurrent Pterygium Clinical Trial

— BRP  

Official title:

Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744756
• Other study ID #: pterygium bevacizumab
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 29, 2012
• Last updated: December 6, 2012
• Start date: February 2012
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: Instituto de Olhos de Goiania
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.

Description:

1. Pacients with recurrent pterygium

2. Anti-VEGF therapy -Bevacizumab

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Recurrent pterygium

Exclusion Criteria:

• Pregnant or lactating women

• History of myocardial infarction

• History of stroke

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium
• Recurrent Pterygium

Intervention

Drug:
• Bevacizumab
One subconjunctival aplication of Bevacizumabe 0,5ml

Locations

Country	Name	City	State
Brazil	Instituto de Olhos de Goiania	Goiania	Goias

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Olhos de Goiania

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pterygium size after subconjunctival bevacizumab	-Size of recurrent pterygium (measured in mm) after injection	8 weeks	Yes
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	-Number of patients with hyposphagma and irritative symptoms after subconjunctival injection	8 weeks	Yes