Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema

Shahid Beheshti University of Medical Sciences74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

Intravitreal injection of bevacizumab (Avastin)DRUG

Intravitreal injection of fasudil and bevacizumab (Avastin)DRUG

intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Tehran, Iran

Outcomes

Primary Outcomes

Best corrected visual acuity

Snellen E-chart

Time frame: 6 months

central macular thickness

spectral domain optical coherence tomography (SD OCT)

Time frame: 6 months

Secondary Outcomes

Status of macular perfusion

Heidelberg fluorescein angiogram (HRA II)

Time frame: 6 months

intraocular inflammation

clinical examination

Time frame: 6 months

Data from ClinicalTrials.gov

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