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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: bevacizumab
* Drug: ziv-aflibercept 1.25 mg
* Drug: ziv-aflibercept 2.5mg


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  | until 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central subfield thickness(CCT) |  | until 6 month |