Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion
NCT ID: NCT01123564
Last Updated: 2010-05-14
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
40 participants
INTERVENTIONAL
2009-08-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lucentis (ranibizumab)
ranibizumab
applied monthly in the first 3 months period, and after this only if visual acuity (VA) decreases with more than 5 letters at any monthly visits
Laser
Argon laser treatment
Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.
Interventions
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ranibizumab
applied monthly in the first 3 months period, and after this only if visual acuity (VA) decreases with more than 5 letters at any monthly visits
Argon laser treatment
Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Central retinal vein occlusion is confirmed by slit-lamp biomicroscopy and fluorescein angiography (FLAG).
* Patients randomized into ranibizumab-treated group do not receive macular laser treatment.
* Macular edema is defined by OCT: the thickness of central foveal area calculated by macular map analysis is above 280 μm and/or retinal thickness is above 330 μm at any region of the macula calculated by retinal thickness analysis.
* Baseline visual acuity is less than 64 ETDRS letters (or 0.4 decimal equivalent).
Exclusion Criteria
* Additional vitreoretinal diseases
* History of pars plana vitrectomy
* Previous macular grid laser treatment
* Intravitreal triamcinolone acetonid treatment
* Complicated cataract surgery
* Advanced glaucomatous damage of optic nerve head
* Cataract (except mild, defined as grade 1 nuclear sclerosis and/or grade 1 posterior subcapsular cataract)
* Age-related macular degeneration
* Pregnancy and lactation
* Women in childbearing potential who are not using double safe contraception
18 Years
ALL
No
Sponsors
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University of Debrecen
OTHER
University of Pecs
OTHER
Responsible Party
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University of Pecs, Medical Scool, Dept of Ophthalmology
Principal Investigators
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Zsolt Balla, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pecs
Locations
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Debrecen Medical and Health Science Center Dept of Ophthalmology
Debrecen, , Hungary
University of Pecs, Medical School, Department of Ophthalmology
Pécs, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRFB002AHU02T
Identifier Type: -
Identifier Source: org_study_id
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