NCT00720928

Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Ocular Behcet's Disease,
• Non-Infectious Uveitis
• Refractory Uveitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-12-01
• Completion: 2010-05-01
• First posted: 2008-07-23
• Last updated: 2008-07-29

Locations

1 site across 1 country: South Korea