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Intravitreal Bevacizumab alone or in combination with 1 mg Triamcinolone in diabetic macular edema

Protocol summary

Summary
Diabetic retinopathy is the main sight threatening disease in the developed world. Further, it is an increasing cause of blindness in developing countries. The goal of this study is to introduce safer and more effective treatment that can reduce the number of injections. This study will be conducted on 50 patients with bilateral diabetic macular edema in non-proliferative phase that have no previous medical or surgical treatment for it and will be visited in retinal clinic of Farabi eye hospital from October 2013 till June 2014. Each eye of a 50 patients will be randomly allocated to 2 different groups: IVB group, eyes receiving IVB injection alone; IVB/IVT group, eyes receiving IVB injection plus IVT. Before treatment complete ocular examination (include visual acuity), optical coherence tomography (OCT) and fluorescein angiography (FA) will be done. Each patient will be followed up for about 2 years. Complete ocular examination including Intraocular pressure, visual acuity and cataract progression estimation and also OCT will be done at follow ups sessions (2week, 4 week, 6 week, 8 week, 12 week, 6 month, 12 month and 24 month after treatments) . Finally two groups will be compared based on different visual acuity improvement, central macular reduction, cataract formation and intraocular pressure elevation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014080818733N1
Registration date: 2015-03-16, 1393/12/25
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-03-16, 1393/12/25
Registrant information
Name
Hamid Riazi Esfahani
Name of organization / entity
Farabi Eye hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2255 5790
Email address
h-riazi@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research- Tehran University of Medical Science
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-05-17, 1394/02/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intravitreal Bevacizumab alone or in combination with 1 mg Triamcinolone in diabetic macular edema
Public title
effect of Bevacizumab alone or in combination with 1 mg Triamcinolone for treatment of diabetic retina swelling
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: bilateral macular edema with foveal involvement; Visual acuity between 20/40-20/400; Age more than 20; HbA1c more less than 10; Blood pressure less than 160/100. Exclusion criteria: previous panretinal or focal laser photocoagulation; prior vitreoretinalr surgery or injection; unilateral cataract surgery; history of glaucoma or ocular hypertension; VA worse than 20/400; proliferative diabetic retinopathy; significant media opacity; Monocularity; Central macular thickness>320; pregnancy; serum creatinine>3 mg/dl; other retinal diseases; unilateral cataract surgery; Cataract surgery during last 3 months; macular ischemia (Foveal avascular zone>100); uncontrolled blood pressure or diabetes with medication; previous corticostroid consumption during last 3 months; HbA1c>10
Age
From 20 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Farabi eye hospital ethic committee / Tehran University Of Medical Science
Street address
Farabi eye hospital-Qazvin Sq.
City
Tehran
Postal code
Approval date
2013-05-30, 1392/03/09
Ethics committee reference number
ERC/R/332

Health conditions studied

1

Description of health condition studied
Diabetic Macular Edema
ICD-10 code
H36.0
ICD-10 code description
Diabetic retinopathy

Primary outcomes

1

Description
Visual acuity
Timepoint
At baseline before injection and then 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months,12 months and 24 months after first injection
Method of measurement
Snellen chart

2

Description
Macular Thickness
Timepoint
At baseline before injection and then 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months,12 months and 24 months after first injection
Method of measurement
Optical coherencetomography( Heidelberg spectoralis Sd)( roct/germany)OCT

Secondary outcomes

1

Description
Lens Cataract
Timepoint
Base line and each 2 months after injection
Method of measurement
Slit-lamp Examination

2

Description
Intraocular Pressure
Timepoint
At baseline before injection and then 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months,12 months and 24 months after first injection
Method of measurement
Goldman tonometry

Intervention groups

1

Description
For the IVB group, 0.05 ml (1.25 mg) of bevacizumab was injected intravitreally with a 27-gauge needle through the supratemporal quadrant.
Category
Treatment - Drugs

2

Description
For the IVB+IVT group, 0.05 ml (1.25 mg) of Bevacizumab was injected intravitreally with a 27-gauge needle through the infratemporal quadrant in combination with 0.025 ml of Triamcinolone(1mg).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Hamid Riazi Esfahani
Street address
Farabi Eye hospital- Qazvin Sq
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice-chancellor for research-Tehran University of Medical Science
Full name of responsible person
Dr.Mohammad Riazi Esfahani
Street address
Tehran University of Medical Science- Poorsina St.- 16th Azar Ave.
City
Tehran
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-Tehran University of Medical Science
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
Eye research center, Farabi Eye Hospital
Full name of responsible person
Hamid Riazi Esfahani
Position
Resident of ophthalmology
Other areas of specialty/work
Street address
Qazvin Aq
City
Tehran
Postal code
Phone
+98 21 5542 1002
Fax
Email
hamidriazi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Eye research cente,r Farabi Eye Hospital
Full name of responsible person
Mohammad Riazi Esfahani
Position
Professor of ophthalmology/ director of eye research center
Other areas of specialty/work
Street address
Qazvin sq
City
Tehran
Postal code
Phone
+98 21 5542 1010
Fax
Email
Riazifahimi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Eye research center, Farabi Eye Hospital
Full name of responsible person
Hamid Riazi Esfahani
Position
Resident of ophthalmology
Other areas of specialty/work
Street address
Qazvin Sq
City
tehran
Postal code
Phone
00
Fax
Email
Hamidriazi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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