Ozurdex as Adjunct to Avastin Compared to Avastin Alone in Treatment of Patients With Diabetic Macular Edema
NCT ID: NCT01309451
Last Updated: 2014-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
40 participants
INTERVENTIONAL
2011-03-31
2013-04-30
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
SINGLE
Study Groups
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Bevacizumab alone
Bevacizumab
intravitreal, 1.25mg., monthly
Combined group
Bevacizumab plus Ozurdex
Bevacizumab
intravitreal, 1.25mg., monthly
dexamethasone intravitreal implant
0.7mg, intravitreal every 4 months
Interventions
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Bevacizumab
intravitreal, 1.25mg., monthly
dexamethasone intravitreal implant
0.7mg, intravitreal every 4 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 1 or type 2 diabetes
* BCVA score of \>24 and \<78 letters
* Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) \>250microns
Exclusion Criteria
* Intravitreal steroid treatment in the last 8 weeks
* PRP or Focal laser in last 4 months
* Active iris neovascularization
18 Years
ALL
No
Sponsors
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Maturi, Raj K., M.D., P.C.
INDIV
Responsible Party
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Raj K. Maturi, MD
PI
Principal Investigators
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Raj K Maturi, MD
Role: PRINCIPAL_INVESTIGATOR
Midwest Eye Institute
Locations
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Raj K. Maturi, MD
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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OA002
Identifier Type: -
Identifier Source: org_study_id
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