Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

Phase 2

• Conditions: Non-proliferative Diabetic Retinopathy
• Interventions: Other: Follow-up with regular examination for determination of DR progression; Drug: Intravitreal Bevacizumab IVB

• Registration Number: NCT04511715
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Study First Posted: 2020-08-13
• Last Update Posted: 2020-08-13
• Study Start: 2020-09-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
undergo regular follow-up for Diabetic Retinopathy	Follow-up with regular examination for determination of DR progression	-
Intravitreal Bevacizumab IVB group	Intravitreal Bevacizumab IVB	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with equal or more than 2 stages of progression in diabetic retinopathy staging	12 months	Multiple fundus photographs interpreted by a single vitreoretinal surgeon who is blind to the study groups

Secondary Outcome Measures

Name	Time	Method
Best corrected visual acuity	12 months	Best corrected visual acuity based on ETDRS letter scale and logMAR
Number of visits	12 months	Number of visits in each time point
Central retinal thickness	12 months	Central retinal thickness according to macular ocular coherence tomography