Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Shahid Beheshti University of Medical Sciences
• Treatments: 1-(5-Isoquinolinesulfonyl)-2-Methylpiperazine; Bevacizumab; Fasudil

Criteria

Inclusion Criteria:

• Diabetic patients with diabetic macular edema (DME) and:

• Central macula thickness> 250μm

• Visual acuity < 20/40

• No active proliferative diabetic retinopathy

• No history of intravitreal anti-VEGF drug injection or macular laser photocoagulation (MPC) within the past 3 months

Exclusion Criteria:

• History of vitrectomy

• History of cataract surgery within the past 6 months

• History of glaucoma or uveitis

• Presence of any macular disorder other than DME

• Presence of traction on the macula

• Significant media opacity

• Serum creatinine>3mg/ml