Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease
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|ClinicalTrials.gov Identifier: NCT00720928|
Recruitment Status : Unknown
Verified July 2008 by Asan Medical Center.
Recruitment status was: Recruiting
First Posted : July 23, 2008
Last Update Posted : July 29, 2008
To describe the safety and efficacy of intravitreal flucinolone acetonide implants in the management of patients having refractory ocular Behcet's disease
A descriptive observational study
A 1-year, multi-center (including four Korean medical centers) observational study
|Condition or disease||Intervention/treatment||Phase|
|Ocular Behcet's Disease, Non-Infectious Uveitis Refractory Uveitis||Drug: flucinolone acetonide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Prospective Single Arm Study to Assess the Efficacy and Safety of RETISERT (Intravitreal Flucinolone Acetonide 0.59mg) in Patients With Refractory Ocular Behcet's Disease|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||December 2009|
|Estimated Study Completion Date :||May 2010|
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).
Drug: flucinolone acetonide
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.
Other Name: RETISERT
- 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 [ Time Frame: 1 year ]
- Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720928
|Contact: Young Hee Yoon, MDfirstname.lastname@example.org|
|Contact: Don-Il Ham, MDemail@example.com|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Young Hee Yoon, MD 822-3010-3680 firstname.lastname@example.org|
|Contact: Don-Il Ham, MD 822-3410-3567 email@example.com|
|Principal Investigator:||Young Hee Yoon, MD||Asan Medical Center|