Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

NCT04511715 | Unknown Phase 2

• 1 other identifier: 9800
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-proliferative Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Best corrected visual acuity

  12 months

• Central retinal thickness

  12 months

• Number of visits

  12 months

Study Arms (2)

Intravitreal Bevacizumab IVB group

ACTIVE COMPARATOR

Drug: Intravitreal Bevacizumab IVB

undergo regular follow-up for Diabetic Retinopathy

SHAM COMPARATOR

Other: Follow-up with regular examination for determination of DR progression

Interventions

Intravitreal Bevacizumab IVB DRUG

Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment

Intravitreal Bevacizumab IVB group

Follow-up with regular examination for determination of DR progression OTHER

regular examination for determination of DR progression

undergo regular follow-up for Diabetic Retinopathy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Central Study Contacts

Homayon Nikkhah, MD

CONTACT

009822591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ophthalmic research center

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 13, 2020
• Study Start: September 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: November 1, 2021
• Last Updated: August 13, 2020

Record last verified: 2020-08