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
PHASE4
20 participants
INTERVENTIONAL
2015-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Group
Ozurdex intravitreal injection
Ozurdex intravitreal injection
1. Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline
2. AC paracentesis at 6 wk
3. intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk
Interventions
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Ozurdex intravitreal injection
1. Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline
2. AC paracentesis at 6 wk
3. intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk
Eligibility Criteria
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Inclusion Criteria
* Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
* Diabetic patients with cystoids macular edema
* Minimum central thickness on OCT not less than 300 microns
* BCVA 20/30\~20/320
Exclusion Criteria
* Patients with history of ocular hypertension or glaucoma
* Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
* Patients with macular ischemia on FFA
* Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
* Patients whose posterior lens capsule is not intact.
* patients with known hypersensitivity to any components of this product.
* patients with vitreous hemorrhage
* patients who have systemic treatment effect on study results
* patients who enrolled other clinical study
ALL
No
Sponsors
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Nune Eye Hospital, Seoul, Korea
OTHER
Responsible Party
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Oh Woong Kwon
Chief of retina center in Nune Eye Hospital
Principal Investigators
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Oh Woong Kwon, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Nune Eye Hospital
Locations
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Nune Eye Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRBF004
Identifier Type: -
Identifier Source: org_study_id
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