Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

Non-proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04511715
• Other study ID #: 9800
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: August 2020
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Homayon Nikkhah, MD
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: November 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Non-proliferative Diabetic Retinopathy
• Retinal Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Best corrected visual acuity	Best corrected visual acuity based on ETDRS letter scale and logMAR	12 months
Secondary	Central retinal thickness	Central retinal thickness according to macular ocular coherence tomography	12 months
Secondary	Number of visits	Number of visits in each time point	12 months