drugset / Trial / NCT01823081

Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

NCT01823081

Phase 3 Completed 74 enrolled Shahid Beheshti University of Medical Sciences
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2013-01
Primary completion
2013-06
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fasudil Small molecule 0.025 mg Intravitreal
Comparator Fasudil Small molecule 0.05 ml Intravitreal
Comparator Bevacizumab Monoclonal antibody 0.05 ml
Comparator Bevacizumab Monoclonal antibody 1.25 mg