Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
Phase 3
Completed
- Conditions
- Diabetic Macular Edema
- Interventions
- Drug: Intravitreal injection of bevacizumab (Avastin)Drug: Intravitreal injection of fasudil and bevacizumab (Avastin)
- Registration Number
- NCT01823081
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 74
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intravitreal bevacizumab (Avastin) Intravitreal injection of bevacizumab (Avastin) Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks Combined intravitreal fasudil and bevacizumab (Avastin) Intravitreal injection of 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 Measures
Name Time Method Best corrected visual acuity 6 months Snellen E-chart
central macular thickness 6 months spectral domain optical coherence tomography (SD OCT)
- Secondary Outcome Measures
Name Time Method Status of macular perfusion 6 months Heidelberg fluorescein angiogram (HRA II)
intraocular inflammation 6 months clinical examination