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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02645734
• Other study ID #: 93210
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: January 2, 2016
• Last updated: January 4, 2016

Study information

• Verified date: October 2015
• Source: hahid Beheshti University of Medical Sciences
• Contact: Masoud Soheilian, MD
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran:Ethic committe
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 133
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• bevacizumab
1.25 mg of bevacizumab is injected
• ziv-aflibercept 1.25 mg
1.25 mg of ziv-aflibercept is injected
• ziv-aflibercept 2.5mg
2.5 mg of ziv-aflibercept is injected

Locations

Country	Name	City	State
Iran, Islamic Republic of	Islamic Republic of Iran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity		until 6 month	Yes
Secondary	central subfield thickness(CCT)		until 6 month	Yes