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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

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.

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Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Injection intravitreous bevacizumab

Injection intravitreous bevacizumab at a dose 1.25mg

Group Type ACTIVE_COMPARATOR

bevacizumab

Intervention Type DRUG

1.25 mg of bevacizumab is injected

Injection ziv-aflibercept at dose of 1.25 mg

Group Type ACTIVE_COMPARATOR

ziv-aflibercept 1.25 mg

Intervention Type DRUG

1.25 mg of ziv-aflibercept is injected

Injection ziv-aflibercept at dose of 2.5 mg

Group Type ACTIVE_COMPARATOR

ziv-aflibercept 2.5mg

Intervention Type DRUG

2.5 mg of ziv-aflibercept is injected

Interventions

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bevacizumab

1.25 mg of bevacizumab is injected

Intervention Type DRUG

ziv-aflibercept 1.25 mg

1.25 mg of ziv-aflibercept is injected

Intervention Type DRUG

ziv-aflibercept 2.5mg

2.5 mg of ziv-aflibercept is injected

Intervention Type DRUG

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes