In this randomized clinical trial, 100 eyes with nonproliferative diabetic retinopathy will be included and divided randomly into 2 groups: Intravitreal Bevacizumab group (50 eyes) that receive 6 bimonthly intravitreal bevacizumab, and control group (50 eyes) that undergo regular follow-up for Diabetic Retinopathy. Diabetic macular edema (DME) will be treated independently in all groups by intravitreal bevacizumab. Primary outcome will be the percentage of patients with progression of 2 or more stages through international diabetic retinopathy staging. The secondary measures will be changes in best corrected visual acuity (BCVA) and central macular thickness (CMT), and number of examinations and injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment
regular examination for determination of DR progression
Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging
Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups
Time frame: 12 months
Best corrected visual acuity
Best corrected visual acuity based on ETDRS letter scale and logMAR
Time frame: 12 months
Central retinal thickness
Central retinal thickness according to macular ocular coherence tomography
Time frame: 12 months
Number of visits
Number of visits in each time point
Time frame: 12 months
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