Purpose: to evaluate the efficacy and safety of itravitreal bevacizumab in proliferative diabetic retinopathy (PDR)patients.
Design: Quasi clinical study
Methods: 39 eyes of 26 PDR patients were evaluated. All patients completed 12 weeks of follow-up. Patients were treated with one intravitreal injection of 1.25 mg of bevacizumab. Evaluation consisted of a complete ophthalmologic examination, including Snellen Visual acuity (VA) measurement, ophtalmoscopy and fluorescein angiography(FA).
Main outcome measures: changes in VA and FA.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903314232N1
Registration date:2010-11-26, 1389/09/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-11-26, 1389/09/05
Registrant information
Name
Ebrahim Mikaniki
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1219 9015
Email address
e.mikaniki@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Babol University of Medical Sciences
Expected recruitment start date
2007-10-31, 1386/08/09
Expected recruitment end date
2009-10-31, 1388/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Intravitreal Bevacizumab (Avastin) therapy on visual acuity in patients with Proliferative Diabetic Retinopathy
Public title
Intravitreal Bevacizumab (Avastin) therapy for Proliferative Diabetic Retinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Patients were not offered treatment if they had uncontrolled hypertension or recent myocardial infarction or cerebral vascular accident.
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol university of medical sciences
Street address
Ganj Afrooz st., Babol university of medical sciences
City
Babol
Postal code
Approval date
2010-10-12, 1389/07/20
Ethics committee reference number
1816
Health conditions studied
1
Description of health condition studied
diabetic retinopathy
ICD-10 code
H36.0
ICD-10 code description
Retinal disorders in diseases classified elsewhere
Primary outcomes
1
Description
Visual Acuity
Timepoint
0, 4, 12 weeks
Method of measurement
complete ophtalmic examination
Secondary outcomes
1
Description
Speed of improvement and durability of visual acuity
Timepoint
4 and 12 weeks after intervention
Method of measurement
ophtalmic examination
Intervention groups
1
Description
One intravitreal injection of 1.25 mg of bevacizumab (Avastin)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Mikaniki
Street address
Ganj Afrooz st., Babol university of medical sciences
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research; Babol university of medical sciences
Full name of responsible person
Vice chancellor for research
Street address
Ganj Afrooz st., Babol university of medical sciences
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research; Babol university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Ebrahim Mikaniki
Position
Assistant Professor
Other areas of specialty/work
Street address
Ganj Afrooz st., Babol university of medical sciences
City
Babol
Postal code
Phone
+98 11 1219 9015
Fax
Email
dr_emikaniki@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Ebrahim Mikaniki
Position
Assistant Professor
Other areas of specialty/work
Street address
Ganj Afrooz st., Babol university of medical sciences
City
Babol
Postal code
Phone
+98 11 1219 9015
Fax
Email
dr_emikaniki@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol university of medical sciences
Full name of responsible person
Ebrahim Mikaniki
Position
Assistant Professor
Other areas of specialty/work
Street address
Ganj Afrooz st., Babol university of medical sciences
City
Babol
Postal code
Phone
+98 11 1219 9015
Fax
Email
dr_emikaniki@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)