The Effect of Bevacizumab on Corneal Neovascularization (BQ-1-08-ARVO)
Primary Purpose
Corneal Neovascularization
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Neovascularization focused on measuring bevacizumab, cornea, neovascularization
Eligibility Criteria
Inclusion Criteria:
- Corneal Neovascularization
- Stable lesion
Exclusion Criteria:
- Diabetes
- Autoimmune diseases
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
A single intraoperative subconjunctival application of bevacizumab and 2 months follow-up
Outcomes
Primary Outcome Measures
The Effect of Bevacizumab on Corneal Neovascularization
Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography
Secondary Outcome Measures
Full Information
NCT ID
NCT00797303
First Posted
November 22, 2008
Last Updated
December 1, 2011
Sponsor
Instituto de Olhos de Goiania
1. Study Identification
Unique Protocol Identification Number
NCT00797303
Brief Title
The Effect of Bevacizumab on Corneal Neovascularization
Acronym
BQ-1-08-ARVO
Official Title
The Effect of Bevacizumab on Corneal Neovascularization
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto de Olhos de Goiania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.
Detailed Description
To evaluate the effect of repeated subconjunctival bevacizumab (Avastin®, Roche, Rio de Janeiro, Brazil) on inflammatory corneal neovascularization.
Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Neovascularization
Keywords
bevacizumab, cornea, neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
A single intraoperative subconjunctival application of bevacizumab and 2 months follow-up
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months
Primary Outcome Measure Information:
Title
The Effect of Bevacizumab on Corneal Neovascularization
Description
Eight patients with corneal neovascularization were treated with subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent corneal neovascularization for at least 6 months unresponsive to other treatments. Patients were monitored by ophthalmic exam and anterior segment photography
Time Frame
Compare the results
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Corneal Neovascularization
Stable lesion
Exclusion Criteria:
Diabetes
Autoimmune diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belquiz A Nassaralla, PhD
Organizational Affiliation
Instituto de Olhos de Goiânia
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
The Effect of Bevacizumab on Corneal Neovascularization
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