Status:
COMPLETED
Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
Lead Sponsor:
Shahid Beheshti University of Medical Sciences
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01823081
Start Date
January 1 2013
End Date
December 1 2015
Last Update
May 11 2017
Active Locations (1)
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1
Tehran, Iran