The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema

January 4, 2016 updated by: Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

The Comparison Between the Therapeutic Effect of Intravitreal Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema

In this double clinical trial 132 patient with the history of DME (Diabetic Macular Edema) to receive intravitreous bevacizumab at a dose of 1.25mg (44 patient) , ziv-aflibercept at dose of 1.25 mg (44 patient) , ziv-aflibercept at dose of 2.5 mg (44 patient) .

The study drugs were administered as often as every 4 weeks for 3 months.monitoring of best-corrected visual acuity, CST ( Central Subfield Thickness) by OCT (Optical coherence tomography) was done from base line ,4 weeks, 8weeks after injection.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

133

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The patient at least 18 years old had type 1 or 2 diabetes who presented with Central DME involvement (defined as retinal thickening involving 1mm central sub field thickness(CCT)
  • Have at least a BCVA ( best corrected visual acuity) between 20/50 to 20/320 Snellen equivalent
  • Have received to anti-VEGF( anti -vascular endothelial growth factor) and laser treatment within the previous 3 months

Exclusion Criteria:

  • Uncontrolled glaucoma/uncontrolled diabet , high risk PRP(pan-retinal photocoagulation), one eye
  • Prior treatment with intravitreal or peribulbar injection and laser therapy during the last 3 months
  • Substantial cataract, history of uveitis
  • Macular edema due to a cause other than DME
  • VMT(Vitreomacular traction ) and ERM (epiretinal membrane)

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Injection intravitreous bevacizumab
Injection intravitreous bevacizumab at a dose 1.25mg
Drug: bevacizumab
1.25 mg of bevacizumab is injected
Active Comparator: Injection ziv-aflibercept at dose of 1.25 mg
Drug: ziv-aflibercept 1.25 mg
1.25 mg of ziv-aflibercept is injected
Active Comparator: Injection ziv-aflibercept at dose of 2.5 mg
Drug: ziv-aflibercept 2.5mg
2.5 mg of ziv-aflibercept is injected

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual acuity
Time Frame: until 6 month
until 6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
central subfield thickness(CCT)
Time Frame: until 6 month
until 6 month

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

Primary Completion (Anticipated)

February 1, 2016

Study Registration Dates

First Submitted

January 2, 2016

First Submitted That Met QC Criteria

January 4, 2016

First Posted (Estimate)

January 5, 2016

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 93210

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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