Comparison of the effect of intravitreal injection of bevacizumab (Stevenet) alone with intravitreal injection of bevacizumab and triamcinolone in the treatment of diabetic macular edema with a thickness greater than 500 microns in patients
Phase 1
Recruiting
- Conditions
- Diabetic macular edema.Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edemaE08.311
- Registration Number
- IRCT20211130053229N1
- Lead Sponsor
- Kerman University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Patients with clinically significant DME according to ETDRS criteria
Patients with clinically significant DME based on criteria of central thickness greater than 500 microns
Exclusion Criteria
History of previous DME treatment (focal or panretinal laser coagulation or IVB or IVT)
Eye surgery
Glaucoma or ocular hypertension
monocular vision
pregnancy
Significant media opacity
CMT<500
The patient's absence in follow-up in the following weeks
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method BCVA change based on LogMAR chart. Timepoint: BCVA measurement at baseline and at week 12. Method of measurement: Based on Snellen chart.
- Secondary Outcome Measures
Name Time Method Changes in central macular thickness (CMT). Timepoint: CMT changes at weeks 4, 8, 12. Method of measurement: Optical coherence tomography.