Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

August 12, 2020 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intravitreal Bevacizumab IVB group
Drug: Intravitreal Bevacizumab IVB
Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment
SHAM_COMPARATOR: undergo regular follow-up for Diabetic Retinopathy
Other: Follow-up with regular examination for determination of DR progression
regular examination for determination of DR progression

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (ACTUAL)

August 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 13, 2020

Last Update Submitted That Met QC Criteria

August 12, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9800

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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