Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients
NCT ID: NCT03391219
Last Updated: 2018-01-05
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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UNKNOWN
PHASE2/PHASE3
36 participants
INTERVENTIONAL
2018-01-31
2018-10-31
Brief Summary
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Methods:
In this study patients with retinal vein occlusion patient who had at least three or more intravitreal AntiVEGF injection with persistence of macular edema at funduscopic examination is recruited. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + Fasudil" and in injected intravitreally for 3 times monthly. In "Bevacizumab+Fasudil" group patients receive two injections at each session Bavacizumab and Fasudil. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.
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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
injection bevacizumab
1.25 mg/0.05 cc bevacizumab
intravitreal Bavacizumab and Fasudil
injection Combined Bevacizumab and Fasudil
1.25 mg/0.05 cc bevacizumab and 0.15mg/0.05 cc fasudil
Interventions
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injection bevacizumab
1.25 mg/0.05 cc bevacizumab
injection Combined Bevacizumab and Fasudil
1.25 mg/0.05 cc bevacizumab and 0.15mg/0.05 cc fasudil
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Shahid Beheshti University of Medical Sciences
OTHER
Responsible Party
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Zahra Rabbani Khah
Head of ophthalmic research center
Locations
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Ophthalmic Research Center
Tehran, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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96299
Identifier Type: -
Identifier Source: org_study_id
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