Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease
Recruitment status was Recruiting
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
Ocular Behcet's Disease,
Drug: flucinolone acetonide
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: Yes ]
- Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2008|
|Estimated Study Completion Date:||May 2010|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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
A multi-center, prospective single arm study to assess the efficacy and safety of retisert (intravitreal flucinolone acetonide 0.59 mg) in patients with refractory ocular Behcet's disease. This study will be conducted at 4 sites, located in Korea. The number of subject is expected approximately 15 patients. The medical records for the patients meeting following inclusion/exclusion criteria will be collected until 1 year after implantation.
|Contact: Young Hee Yoon, MDemail@example.com|
|Contact: Don-Il Ham, MDfirstname.lastname@example.org|
|Korea, Republic of|
|Asan Medical Center||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Young Hee Yoon, MD 822-3010-3680 email@example.com|
|Contact: Don-Il Ham, MD 822-3410-3567 firstname.lastname@example.org|
|Principal Investigator:||Young Hee Yoon, MD||Asan Medical Center|