- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02645734
The Effect of Bevacizumab and Ziv-aflibercept in Diabetic Macular Edema
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Masoud Soheilian, MD
- Phone Number: 009822591616
- Email: labbafi@hotmail.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
- Islamic Republic of Iran
-
Contact:
- Masoud Soheilian, MD
- Phone Number: 009822591616
- Email: labbafi@hotmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
1.25 mg of bevacizumab is injected
|
Active Comparator: Injection ziv-aflibercept at dose of 1.25 mg
|
1.25 mg of ziv-aflibercept is injected
|
Active Comparator: Injection ziv-aflibercept at dose of 2.5 mg
|
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
Study record dates
Study Major Dates
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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