Back to resultsPOSTERIOR SUB-TENON'S Avastin
Primary Purpose
Diffuse Diabetic Macular Edema
Status
Unknown status
Phase
Phase 4
Locations
Mexico
Study Type
Interventional
Intervention
bevacizumab (Sub-tenon´s injection)
Sponsored by
About this trial
This is an interventional treatment trial for Diffuse Diabetic Macular Edema focused on measuring Diffuse diabetic macular edema, sub-tenon, Bevacizumab
Eligibility Criteria
Inclusion Criteria:
Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment
Sites / Locations
- Asociación para Evitar la Ceguera en MexicoRecruiting
Outcomes
Primary Outcome Measures
macular volume
Secondary Outcome Measures
macular thickness
best corrected visual acuity
Full Information
NCT ID
NCT00567372
First Posted
November 30, 2007
Last Updated
December 5, 2008
Sponsor
Asociación para Evitar la Ceguera en México
1. Study Identification
Unique Protocol Identification Number
NCT00567372
Brief Title
POSTERIOR SUB-TENON'S Avastin
Official Title
POSTERIOR SUB-TENON'S CAPSULE INJECTION OF BEVACIZUMAB FOR TREATMENT OF DIFFUSE DIABETIC MACULAR EDEMA
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Anticipated)
Study Completion Date
June 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Asociación para Evitar la Ceguera en México
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Posterior sub-tenon's injection of bevacizumab decreased diffuse diabetic macular edema
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Diabetic Macular Edema
Keywords
Diffuse diabetic macular edema, sub-tenon, Bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bevacizumab (Sub-tenon´s injection)
Intervention Description
a single posterior sub-tenon's capsule injection of bevacizumab (2.5 mg /0.1ml)
Primary Outcome Measure Information:
Title
macular volume
Time Frame
baseline, 3,6 and 12 weeks
Secondary Outcome Measure Information:
Title
macular thickness
Time Frame
baseline,3,6 and 12 weeks
Title
best corrected visual acuity
Time Frame
baseline, 3,6 and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with diffuse diabetic macular edema non-proliferative diabetic retinopathy Maculat thickness ≥250 μ BCVA ≥ 20/400 Without any treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Vera-Rodriguez, MD
Phone
525510841400
Ext
1171
Email
retinamex@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Vera, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en Mexico
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hugo Quiroz-Mercado, MD
Organizational Affiliation
Denver Health Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adai Pérez-Montesinos, MD
Organizational Affiliation
Asociación para Evitar la Ceguera en Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación para Evitar la Ceguera en Mexico
City
Mexico DF
State/Province
DF
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoko Burgoa, Lic
Phone
525514841400
Ext
1171
Email
retinamex@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
POSTERIOR SUB-TENON'S Avastin
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