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

Sponsor
Shahid Beheshti University of Medical Sciences
Study ID
NCT02645734
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Status verified
Oct 2015
Primary completion
Feb 29, 2016

Study Design

Enrollment
133 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Injection intravitreous bevacizumab
    Injection intravitreous bevacizumab at a dose 1.25mg
  • Active Comparator: Injection ziv-aflibercept at dose of 1.25 mg
    Injection ziv-aflibercept at dose of 1.25 mg
  • Active Comparator: Injection ziv-aflibercept at dose of 2.5 mg
    Injection ziv-aflibercept at dose of 2.5 mg

Primary Outcome Measure

visual acuity [ Time Frame: until 6 month ]

Central Contacts

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