Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

• Status: Not yet recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• Presence of severe NPDR with DRSS score more than 53 with or without diabetic macular edema

• Diagnosis of DM (type 1 or 2) with age more than 18 years' old

• Visual acuity from 20/25 to 20/40 according to Snellen chart examination or more than 69 letters according to ETDRS chart

Exclusion Criteria:

• Presence of proliferative diabetic retinopathy features including vitreous hemorrhage or optic disc or retinal neovascularization

• History of retinal laser photocoagulation

• Tractional retinal detachment involving the macula

• Evidence of neovascularization of angle on examination

• Macular edema due to a cause other than DME

• Any ocular condition which may change visual acuity during the study

• History of intravitreal injection of anti-vascular endothelial growth factor agent in past 3 months

• History of any use of intravitreal corticosteroid

• History of major intra-ocular surgery except cataract surgery in the past 6 months

• History of thromboembolic every in the past 3 months