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Subconjunctival Bevacizumab and Recurrent Pterygium (BRP)

Primary Purpose

Recurrent Pterygium

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Instituto de Olhos de Goiania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Pterygium focused on measuring Subconjunctival Bevacizumab, Recurrent pterygium

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Recurrent pterygium

Exclusion Criteria:

  • Pregnant or lactating women
  • History of myocardial infarction
  • History of stroke

Sites / Locations

  • Instituto de Olhos de Goiania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subconjunctival Bevacizumab

Arm Description

One aplication of subconjunctival Bevacizumab 0,5 ml

Outcomes

Primary Outcome Measures

Pterygium size after subconjunctival bevacizumab
-Size of recurrent pterygium (measured in mm) after injection

Secondary Outcome Measures

Number of Participants with Adverse Events as a Measure of Safety and Tolerability
-Number of patients with hyposphagma and irritative symptoms after subconjunctival injection

Full Information

First Posted
November 29, 2012
Last Updated
December 6, 2012
Sponsor
Instituto de Olhos de Goiania
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1. Study Identification

Unique Protocol Identification Number
NCT01744756
Brief Title
Subconjunctival Bevacizumab and Recurrent Pterygium
Acronym
BRP
Official Title
Interventional Trial of Subconjunctival Bevacizumab in Recurrent Pterygium
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Olhos de Goiania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A study to research whether subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, retarding and decreasing the size of recurrent pterygium.
Detailed Description
Pacients with recurrent pterygium Anti-VEGF therapy -Bevacizumab

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pterygium
Keywords
Subconjunctival Bevacizumab, Recurrent pterygium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subconjunctival Bevacizumab
Arm Type
Experimental
Arm Description
One aplication of subconjunctival Bevacizumab 0,5 ml
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
One subconjunctival aplication of Bevacizumabe 0,5ml
Primary Outcome Measure Information:
Title
Pterygium size after subconjunctival bevacizumab
Description
-Size of recurrent pterygium (measured in mm) after injection
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
-Number of patients with hyposphagma and irritative symptoms after subconjunctival injection
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Recurrent pterygium Exclusion Criteria: Pregnant or lactating women History of myocardial infarction History of stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larissa S Stival, MD
Organizational Affiliation
Instituto de Olhos de Goiania
Official's Role
Study Chair
Facility Information:
Facility Name
Instituto de Olhos de Goiania
City
Goiania
State/Province
Goias
ZIP/Postal Code
74110120
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
25076364
Citation
Stival LR, Lago AM, Figueiredo MN, Bittar RH, Machado ML, Nassaralla Junior JJ. Efficacy and safety of subconjunctival bevacizumab for recurrent pterygium. Arq Bras Oftalmol. 2014 Jan-Feb;77(1):4-7. doi: 10.5935/0004-2749.20140003.
Results Reference
derived

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Subconjunctival Bevacizumab and Recurrent Pterygium

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