Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

Sponsor
Shahid Beheshti University of Medical Sciences
Study ID
NCT01823081
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

Eligible eyes are randomized to two groups. Group A will receive three intravitreal injections of bevacizumab at 4 week intervals. In group B, three intravitreal injections of combined bevacizumab and fasudil will be performed with the same frequency. Best corrected visual acuity (BCVA) and central macular thickness (CMT) will be evaluated prior to injections and then every 4 weeks for 6 months. Fluorescein angiography will be performed at baseline and at weeks 12 and 24. The two groups will be compared in terms of BCVA and CMT changes.

Key Dates

First listed
Apr 4, 2013
Start date
Jan 31, 2013
Status verified
Jul 2012
Primary completion
Jun 30, 2013
Completion
Dec 31, 2015

Study Design

Enrollment
74 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intravitreal bevacizumab (Avastin)
    Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks
  • Active Comparator: Combined intravitreal fasudil and bevacizumab (Avastin)
    Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks

Primary Outcome Measure

Best corrected visual acuity [ Time Frame: 6 months ]

Related Studies