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

Phase 2

• Conditions: Diabetic Macular Edema
• Interventions: Drug: bevacizumab; Drug: ziv-aflibercept 1.25 mg; Drug: ziv-aflibercept 2.5mg

• Registration Number: NCT02645734
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study First Submitted: 2016-01-02
• Study First Submitted QC: 2016-01-04
• Last Update Submitted: 2016-01-04
• Study First Posted: 2016-01-05
• Last Update Posted: 2016-01-05
• Primary Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection intravitreous bevacizumab	bevacizumab	Injection intravitreous bevacizumab at a dose 1.25mg
Injection ziv-aflibercept at dose of 1.25 mg	ziv-aflibercept 1.25 mg	Injection ziv-aflibercept at dose of 1.25 mg
Injection ziv-aflibercept at dose of 2.5 mg	ziv-aflibercept 2.5mg	Injection ziv-aflibercept at dose of 2.5 mg

Primary Outcome Measures

Name	Time	Method
visual acuity	until 6 month

Secondary Outcome Measures

Name	Time	Method
central subfield thickness(CCT)	until 6 month

Trial Locations

Locations (1)

Islamic Republic of Iran; 🇮🇷 Tehran, Iran, Islamic Republic of