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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: Aflibercept; Bevacizumab

Criteria

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)