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Efficacy of Macular laser Photocoagulation with or without Intravitreal Injection of Bevacizumab (Avastin) or Triamcinolone Acetonide for Diffuse Diabetic Macular Edema

Efficacy of Macular laser Photocoagulation with or without Intravitreal Injection of Bevacizumab (Avastin) or Triamcinolone Acetonide for Diffuse Diabetic Macular Edema

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT201205029617N1
Enrollment
105
Registered
2012-05-10
Start date
2011-05-10
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Diabetic Macular Edema. Disorders of choroid and retina

Interventions

Intervention 1: In group of Laser Photocoagulation alone, we do Macalar Laser Photocoagulation . Intervention 2: In group of Laser Photocoagulation with intravitreal injection of Triamcinolone Acetoni
Rehabilitation
Treatment - Drugs
In group of Laser Photocoagulation alone, we do Macalar Laser Photocoagulation .
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 late
In group of Laser Photocoagulation with intravitreal Bevacizumab(Avastin), we do Macular laser photocoagulation then 1.25mg Bevacizumab will inject intravitrealy one week later.

Sponsors

Vice-Chancellor in Research Affairs Ahvaz Jundishapur University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Central Macular Thickness. Timepoint: Before and Three months after Treatment. Method of measurement: Central Macular Thickness Evaluate with OCT Instrument.;Visual Acuity. Timepoint: Before Treatment and Three Months after Treatment. Method of measurement: Visual Acuity check with snellen chart.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Sadeghi.Behnam

Ahvaz Jundishapur Univercity of Medical Scieces

sadeghi.b@ajums.ac.ir+98 61 1222 8076

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026