NCT01823081

Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Shahid Beheshti University of Medical Sciences · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Intravitreal injection of bevacizumab (Avastin)
DRUG	Intravitreal injection of fasudil and bevacizumab (Avastin)	intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-06-01
• Completion: 2015-12-01
• First posted: 2013-04-04
• Last updated: 2017-05-11

Locations

1 site across 1 country: Iran