Sponsor study identifier
interventional
15
1 country
1
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Objectives: To describe the safety and efficacy of intravitreal flucinolone acetonide implants in the management of patients having refractory ocular Behcet's disease Hypothesis: A descriptive observational study Study design: A 1-year, multi-center (including four Korean medical centers) observational study
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
July 18, 2008
Actual (reported)July 23, 2008
Actual (reported)December 2009
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Recurrence in the 36 wks, with one or more of the following events ->2 step Increase in the number of cells in the A/C -2 step increase in the vitreous haze -deterioration in visual acuity
1 year
Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc.
1 year
Posterior uveitis patients having complete or incomplete type of Behcet's disease; typical ocular lesion and at least, one of the main symptoms or two of the additional symptoms. Selection of study eye : For patients with unilateral uveitis, the study eye will be the affected eye; for patients with bilateral uveitis, the study eye will be the more severely affected eye (i.e., the eye having suffered more recurrences in the previous year, or if equal, the eye having received more therapy in the previous year, or if equal, the eye having the worse VA, or if equal, the eye clinically judged to be the more severely affected eye).
Intra-vitreal implantation of RETISERT on the study eye. The implant is a sustained-release delivery system containing 0.59 mg of flucinolone acetonide designed to deliver the drug for approximately 3 years.
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Asan Medical Center
Seoul, 138-736, South Korea
Young Hee Yoon, MD
Asan Medical Center
First Submitted
July 18, 2008
First Posted
July 23, 2008
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2009
Estimated (date passed)Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 29, 2008
Record last verified: 2008-07
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Source: ClinicalTrials.gov.
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