Single Site, Masked, Randomized, Controlled Study to Assess Efficacy of Osurdex as Adjunct to Avastin Compared With Avastin Alone in the Treatment of Patients With Macular Edema Due to Central or Branch Retinal Vein Occlusion
NCT ID: NCT01085734
Last Updated: 2014-04-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2010-03-31
2011-10-31
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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Group 1
Group 1 receives Avastin at baseline followed by sham Osurdex at week 1. Additional Avastin based on macular edema
Avastin
1.25mg intravitreally
Group 2
Group 2 receives Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin based on macular edema
Osurdex
0.7mg intravitreally
Avastin
1.25mg intravitreally
Interventions
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Avastin
1.25mg intravitreally
Osurdex
0.7mg intravitreally
Avastin
1.25mg intravitreally
Eligibility Criteria
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Inclusion Criteria
* Branch retinal vein occlusion or central retinal vein occlusion of less than one year duration
* Best correct visual acuity of greater than 24 and less than 80
* Presence of macular edema defined as OCT central subfield thickness of \>250
Exclusion Criteria
* intravitreal steroid treatment in the study eye within eight weeks of baseline visit
* PRP in the study eye within 4 month of baseline visit
* Active iris neovascularization in study eye
* Uncontrolled systemic disease
* Known history of IOP elevation in response to corticosteroid treatment that is not controlled on 2 glaucoma medications
18 Years
ALL
Yes
Sponsors
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Maturi, Raj K., M.D., P.C.
INDIV
Responsible Party
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Raj K. Maturi, MD
President
Principal Investigators
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Raj K Maturi, MD
Role: PRINCIPAL_INVESTIGATOR
Raj K. Maturi, MD, PC
Locations
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Raj K. Maturi, MD
Indianapolis, Indiana, United States
Countries
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Other Identifiers
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OA001
Identifier Type: -
Identifier Source: org_study_id
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