Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

NCT ID: NCT04511715

Last Updated: 2020-08-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intravitreal Bevacizumab IVB group

Group Type: ACTIVE_COMPARATOR

Intravitreal Bevacizumab IVB

Intervention Type: DRUG

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

undergo regular follow-up for Diabetic Retinopathy

Group Type: SHAM_COMPARATOR

Follow-up with regular examination for determination of DR progression

Intervention Type: OTHER

regular examination for determination of DR progression

Interventions

Intravitreal Bevacizumab IVB

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

Intervention Type: DRUG

Follow-up with regular examination for determination of DR progression

regular examination for determination of DR progression

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Rabbani Khah

Head of ophthalmic research center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Homayon Nikkhah, MD

Role: CONTACT

labbafi@hotmail.com

009822591616

Other Identifiers

9800

Identifier Type: -

Identifier Source: org_study_id