Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intravitreal Bevacizumab for Nonproliferative Diabetic Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04511715
Recruitment Status : Not yet recruiting
First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Non-proliferative Diabetic Retinopathy Drug: Intravitreal Bevacizumab IVB Other: Follow-up with regular examination for determination of DR progression Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intravitreal Bevacizumab for the Improvement of Severe Non-proliferative Diabetic Retinopathy Without DME: a Randomized Clinical Trial
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : November 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 12 months ]
    Best corrected visual acuity based on ETDRS letter scale and logMAR

  2. Central retinal thickness [ Time Frame: 12 months ]
    Central retinal thickness according to macular ocular coherence tomography

  3. Number of visits [ Time Frame: 12 months ]
    Number of visits in each time point


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511715


Contacts
Layout table for location contacts
Contact: Homayon Nikkhah, MD 009822591616 labbafi@hotmail.com

Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Zahra Rabbani Khah, Head of ophthalmic research center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT04511715    
Other Study ID Numbers: 9800
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
 Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors