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

Shahid Beheshti University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: bevacizumab; Drug: ziv-aflibercept 1.25 mg; Drug: ziv-aflibercept 2.5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02645734

93210

Details and patient eligibility

About

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.

Enrollment: 133 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 3 patient groups

Injection intravitreous bevacizumab

Active Comparator group

Description:

Injection intravitreous bevacizumab at a dose 1.25mg

Treatment:

Drug: bevacizumab

Injection ziv-aflibercept at dose of 1.25 mg

Active Comparator group

Description:

Injection ziv-aflibercept at dose of 1.25 mg

Treatment:

Drug: ziv-aflibercept 1.25 mg

Injection ziv-aflibercept at dose of 2.5 mg

Active Comparator group

Description:

Injection ziv-aflibercept at dose of 2.5 mg

Treatment:

Drug: ziv-aflibercept 2.5mg