The Comparison of Efficacy Between Iranian Made Ranibizumab and Imported Ranibizumab in Diabetic Patients with Macular Edema
- Conditions
- Diabetic retinopathy.Type 1 diabetes mellitus with ophthalmic complicationsE10.3
- Registration Number
- IRCT20170303032845N1
- Lead Sponsor
- Aracell zist daru
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 154
Diabetes mellitus type 1 or 2
Center involving macular edema with a central subfield thickness (CST) of >300
Early treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity letter score of 24 to 78 (20/32 to 20/400)
HbA1c<9%
Blood Pressure <150/100
Triglyceride and LDL up to 20% higher than upper normal limits
Pseudophakic patients are allowed to enter the study.
Signed written inform consent
History of intravitreal injection within the past 2 months
History of any ocular surgery within the past 6 months
History of glaucoma or ocular hypertension
Any media opacity in the cornea, lens and vitreous body which interferes with eye examination and imaging.
Monocular patients
Pregnant or breastfeeding women
Proliferative diabetic retinopathy (PDR) with high-risk characteristics
HbA1c>10%
Smoking (more than 10 cigarettes per day)
Use of acetazolamide tablets or intraocular pressure-lowering drops
Use of systemic corticosteroids or nonsteroidal anti-inflammatory eye drops (NSAIDs)
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Central macular thickness. Timepoint: At the beginning of the study (before the intervention), 30 days after injection. Method of measurement: Optical coherence tomography.
- Secondary Outcome Measures
Name Time Method Visual acuity. Timepoint: At the beginning of the study (before the intervention), 7 and 30 days after injection. Method of measurement: Snellen chart.