Comparison of Intravitreal Ranibizumab and Macular Grid-pattern Laser for Treatment of Diabetic Macular Edema
NCT ID: NCT00994799
Last Updated: 2009-10-16
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
50 participants
OBSERVATIONAL
2009-07-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ranibizumab group
patients receiving intravitreal ranibizumab for diabetic macular edema
ranibizumab
10mg/ml intravitreal injection
laser
patients receiving macular grid-pattern laser therapy
macular grid-pattern laser
macular grid-pattern laser therapy
Interventions
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ranibizumab
10mg/ml intravitreal injection
macular grid-pattern laser
macular grid-pattern laser therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of DME secondary to diabetic retinopathy and decrease in vision is due to DME and not due to other causes in the opinion of the investigator
* Patients who have a BCVA score between 78 and 39 letters in the study eye using ETDRS-like visual acuity charts at a testing distance of 4 meters
* Expectation by the investigator that patient will potentially benefit from laser treatment or ranibizumab treatment
* Willing and able to comply with all study procedures
Exclusion Criteria
* Uncontrolled glaucoma or neovascularization of the iris in the study eye
* Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
* Concurrent disease in the study eye that could compromise visual acuity or prevent the improvement of visual acuity (including diabetic proliferative retinopathy) or require medical or surgical intervention during the study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole or choroidal neovascularization of any cause
* Panretinal laser photocoagulation in the study eye within 6 months prior to or during the study or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
* Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc) or intravitreal corticosteroids in the study eye within 3 months prior to randomization
* Any intraocular surgery in the study eye within 3 months prior to randomization
* History of vitrectomy in the study eye
* Ocular conditions in the study eye that require chronic concomitant therapy with topical ocular or systemically administered corticosteroids
* Pregnancy and lactation
18 Years
ALL
No
Sponsors
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Semmelweis University
OTHER
Csolnoky Ferenc County Hospital
UNKNOWN
Szeged University
OTHER
Responsible Party
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University of Szeged Department of Ophthalmology
Principal Investigators
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Lajos Kolozsvari, prof
Role: PRINCIPAL_INVESTIGATOR
Szeged University
Locations
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Semmelweis University Department of Ophthalmology
Budapest, , Hungary
University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology
Szeged, , Hungary
Csolnoky Ferenc County Hospital Dept of Ophthalmolgy
Veszprém, , Hungary
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRFB002DHU06T
Identifier Type: -
Identifier Source: secondary_id
CRFB002AHU04T
Identifier Type: -
Identifier Source: org_study_id
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