Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

Shahid Beheshti University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Diabetic Macular Edema

Treatments: Drug: Intravitreal injection of bevacizumab (Avastin); Drug: Intravitreal injection of fasudil and bevacizumab (Avastin)

Study type: Interventional

Funder types: Other

Identifiers

NCT01823081

91128

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Intravitreal bevacizumab (Avastin)

Active Comparator group

Description:

Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks

Treatment:

Drug: Intravitreal injection of bevacizumab (Avastin)

Combined intravitreal fasudil and bevacizumab (Avastin)

Active Comparator group

Description:

Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks

Treatment:

Drug: Intravitreal injection of fasudil and bevacizumab (Avastin)