Back to resultsThe Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
bevacizumab
ziv-aflibercept 1.25 mg
ziv-aflibercept 2.5mg
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
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)
Sites / Locations
- Islamic Republic of IranRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Injection intravitreous bevacizumab
Injection ziv-aflibercept at dose of 1.25 mg
Injection ziv-aflibercept at dose of 2.5 mg
Arm Description
Injection intravitreous bevacizumab at a dose 1.25mg
Injection ziv-aflibercept at dose of 1.25 mg
Injection ziv-aflibercept at dose of 2.5 mg
Outcomes
Primary Outcome Measures
visual acuity
Secondary Outcome Measures
central subfield thickness(CCT)
Full Information
NCT ID
NCT02645734
First Posted
January 2, 2016
Last Updated
January 4, 2016
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02645734
Brief Title
The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
Official Title
The Comparison Between the Therapeutic Effect of Intravitreal Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
133 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Injection intravitreous bevacizumab
Arm Type
Active Comparator
Arm Description
Injection intravitreous bevacizumab at a dose 1.25mg
Arm Title
Injection ziv-aflibercept at dose of 1.25 mg
Arm Type
Active Comparator
Arm Description
Injection ziv-aflibercept at dose of 1.25 mg
Arm Title
Injection ziv-aflibercept at dose of 2.5 mg
Arm Type
Active Comparator
Arm Description
Injection ziv-aflibercept at dose of 2.5 mg
Intervention Type
Drug
Intervention Name(s)
bevacizumab
Intervention Description
1.25 mg of bevacizumab is injected
Intervention Type
Drug
Intervention Name(s)
ziv-aflibercept 1.25 mg
Intervention Description
1.25 mg of ziv-aflibercept is injected
Intervention Type
Drug
Intervention Name(s)
ziv-aflibercept 2.5mg
Intervention Description
2.5 mg of ziv-aflibercept is injected
Primary Outcome Measure Information:
Title
visual acuity
Time Frame
until 6 month
Secondary Outcome Measure Information:
Title
central subfield thickness(CCT)
Time Frame
until 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Masoud Soheilian, MD
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Islamic Republic of Iran
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Masoud Soheilian, MD
Phone
009822591616
Email
labbafi@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
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