effect of Bevacizumab alone or in combination with 1 mg Triamcinolone for treatment of diabetic retina swelling
- Conditions
- Diabetic Macular Edema.Diabetic retinopathy
- Registration Number
- IRCT2014080818733N1
- Lead Sponsor
- vice-chancellor for research-Tehran University of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
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
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;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 Outcome Measures
Name Time Method ens Cataract. Timepoint: Base line and each 2 months after injection. Method of measurement: Slit-lamp Examination.;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.