Combined Intravitreal Fasudil and Bevacizumab for Diabetic Macular Edema
NCT ID: NCT01823081
Last Updated: 2017-05-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
74 participants
INTERVENTIONAL
2013-01-31
2015-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intravitreal bevacizumab (Avastin)
Dosage: 1.25 mg/0.05 ml Frequency: 3 consecutive injections every 4 weeks
Intravitreal injection of bevacizumab (Avastin)
Combined intravitreal fasudil and bevacizumab (Avastin)
Dosage: bevacizumab 1.25 mg/0.05 ml + fasudil 0.025mg/0.05ml Frequency: 3 consecutive injections every 4 weeks
Intravitreal injection of fasudil and bevacizumab (Avastin)
intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)
Interventions
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Intravitreal injection of bevacizumab (Avastin)
Intravitreal injection of fasudil and bevacizumab (Avastin)
intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)
Eligibility Criteria
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Inclusion Criteria
* 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 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
ALL
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Clinical Professor, Ophthalmic Research Center
Locations
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Tehran, , Iran
Countries
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Other Identifiers
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91128
Identifier Type: -
Identifier Source: org_study_id
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