Efficacy of Macular laser Photocoagulation with or without Intravitreal Injection of Bevacizumab (Avastin) or Triamcinolone Acetonide for Diffuse Diabetic Macular Edema
Background: Diabetic maculopathy is an important cause of visual loss around the world. Gold standard treatment of diabetic maculopathy is macular grid laser photocoagulation, but less than 3% of patients gain better visual acuity after this treatment. Because there is not an effective treatment for diabetic maculopathy, it is needed to use another therapy with laser photocoagulation to treat diabetic macular edema.
Purpose: In this study we evaluate the effect of macular laser photocoagulation on vision and macular thickness of patients of macular edema alone and with intra vitreral injection of triamcinolone or bevacizumab.
Method: 105 patients were randomized in three group; first group, grid laser photocoagulation , second group, 1 week after Macular Laser Photocoagulation 4 mg Tramcinolone Acetonide will inject Intravitrealy and third group, 1 week after Macular Laser Photocoagulation,1.25mg Bevacizumab(Avastin) will inject intravitrealy. In all patients visual acuity and macular thickness measured before and 3 months after treatment and compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205029617N1
Registration date:2012-05-10, 1391/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-10, 1391/02/21
Registrant information
Name
Behnam Sadeghi
Name of organization / entity
Jondishapur Ahvaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1222 8076
Email address
sadeghi.b@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice_chancellor in Research Affairrs of Ahvaz Jundishapur Univercity of Medical Sciences
Expected recruitment start date
2011-05-10, 1390/02/20
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Macular laser Photocoagulation with or without Intravitreal Injection of Bevacizumab (Avastin) or Triamcinolone Acetonide for Diffuse Diabetic Macular Edema
Public title
Efficacy of Macular laser Photocoagulation with or without Intravitreal Injection of Bevacizumab (Avastin) or Triamcinolone Acetonide for Diffuse Diabetic Macular Edema
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients of either gender aged more than18 years; diabetes mellitus (type 1 or 2); best corrected visual acuity (BCVA) in the study eye between 35 and 69 ETDRS letters at 4 m (Snellen equivalent 1/10-5/10); central foveal thickness more than 270 micrometer; media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus imaging; intraocular pressure (IOP )less than 21 mmHg; ability to return for regular study visits; fellow eye has vissual acuity more than 20/400; fellow eye has received no antivascular endothelial growth factor (VEGF) treatment within the past 3 months and diffuse diabetic macular edema based on fluorescein angiography.
Exclusion criteria(ocular criteria were applied to the
study eye only): macular ischemia (foveal avascular
zone [FAZ] more than1000 micrometer
or severe perifoveal intercapillary loss on fluorescein angiography); macular edema due to a cause other than diabetic maculopathy; coexistent ocular disease: a preexisting ocular condition that was likely to preclude vissual acuity improvement despite resolution of macular edema ( foveal atrophy, amblyopia, retinal vascular occlusion, neovascular glaucoma, ...); proliferative diabetic retinopathy
more than one disc in area in peripheral retina with or without vitreous hemorrhage and history of intraoccular surgery like as cataract sugery or vitrectomy.
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
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
Ahvaz Jundishapur University of medical sciences
Street address
Central Department-Golestan Square
City
Ahvaz
Postal code
6135715794
Approval date
2011-05-08, 1390/02/18
Ethics committee reference number
ETH-139
Health conditions studied
1
Description of health condition studied
Diffuse Diabetic Macular Edema
ICD-10 code
H30-H36
ICD-10 code description
Disorders of choroid and retina
Primary outcomes
1
Description
Central Macular Thickness
Timepoint
Before and Three months after Treatment
Method of measurement
Central Macular Thickness Evaluate with OCT Instrument
2
Description
Visual Acuity
Timepoint
Before Treatment and Three Months after Treatment
Method of measurement
Visual Acuity check with snellen chart
Secondary outcomes
empty
Intervention groups
1
Description
In group of Laser Photocoagulation alone, we do Macalar Laser Photocoagulation .
Category
Rehabilitation
2
Description
In group of Laser Photocoagulation with intravitreal injection of Triamcinolone Acetonide, we do Macular Laser Photocoagulation then 4mg Triamcinolone Acetonde will inject intravitrealy one week later.
Category
Treatment - Drugs
3
Description
In group of Laser Photocoagulation with intravitreal Bevacizumab(Avastin), we do Macular laser photocoagulation then 1.25mg Bevacizumab will inject intravitrealy one week later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Hospital-Ahvaz
Full name of responsible person
Dr.Sadeghi.Behnam
Street address
Ophthalmology Department-Emam Hospital-Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor in Research Affairs Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Feghhi.Mostafa
Street address
Golestan Square-Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor in Research Affairs Ahvaz Jundishapur 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
Ahvaz Jundishapur Univercity of Medical Scieces
Full name of responsible person
Dr.Sadeghi.Behnam
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Department of Ophthalmology-Emam Hospital-Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1222 8076
Fax
+98 61 1222 8076
Email
sadeghi.b@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Kasiri.Ali
Position
Attending of Ophthalmology-Vitreoretinal Surgen
Other areas of specialty/work
Street address
Department of Ophthalmology-Emam hospital-Ahvaz
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1222 2670
Fax
+98 61 1222 8076
Email
dr.pazyar@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr.Sadeghi.Behnam
Position
Resident of Ophthalmology
Other areas of specialty/work
Street address
Department of Ophthalmology-Emam Hospital-Ahvaz
City
Ahvaz
Postal code
613571594
Phone
+98 61 1222 8076
Fax
+98 61 1222 8076
Email
sadeghi.b@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)