NCT04511715

Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

Efficacy and Safety of Intravitreal Bevacizumab for the Improvement of Severe Non-proliferative Diabetic Retinopathy Without DME: a Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Intravitreal Bevacizumab IVB	Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment
OTHER	Follow-up with regular examination for determination of DR progression	regular examination for determination of DR progression

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-01-01
• Completion: 2021-11-01
• First posted: 2020-08-13
• Last updated: 2020-08-13