Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease
NCT ID: NCT00720928
Last Updated: 2008-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
15 participants
INTERVENTIONAL
2008-07-31
2010-05-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single group
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).
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* One or both eyes having a history of recurrent or chronic ocular Behcet's disease affecting the eye more than 1 year duration requiring either systemic corticosteroid or other equivalent systemic therapy for at least three months prior to enrollment; OR at least 2 sub-Tenon's injections of corticosteroid for the management of uveitis during the six months prior to enrollment; OR at least 2 separate recurrences within the six months prior to enrollment requiring either systemic corticosteroid therapy or sub-Tenon's injection of corticosteroids
* At the time of enrollment the implanted eye must have: ≤ 10 anterior chamber cells/HPF and a vitreous haze ≤ grade 2
* Visual acuity of at least 1.4 logMAR units (Snellen 20/500).
Exclusion Criteria
* History of only posterior segment uveitis not accompanied by vitritis or macular edema
* History of iritis only and no vitreous cells or vitreous haze
* Uveitis with infectious etiology
* Vitreous hemorrhage
* Presence of a toxoplasmosis scar in the study eye
* Peripheral retinal detachment in area of implantation
* Media opacity precluding evaluation of the retina and vitreous
* Uncontrolled increased intraocular pressure(IOP)(\>21mmHg)at the time of retisert implantation
* Ocular surgery on the study eye within 3 months prior to enrollment
* Patients requiring chronic systemic corticosteroid therapy (\>15mg prednisone daily) or systemic immunosuppressive therapy to manage non-ocular disease
* Patients who have tested positive for human immunodeficiency virus
* Pregnant or lactating females
* Females of childbearing potential considering becoming pregnant during the course of the study and those not taking effective contraception/precautions to avoid pregnancy
* Patients for whom, in the physician's opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study
* Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow-up in the 1 year
* Patients who are currently enrolled in any other IND or investigational study or who have participated in an IND or investigational study within 1 month of enrollment
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Seoul National University Hospital
OTHER
Kyunghee University Medical Center
OTHER
Asan Medical Center
OTHER
Responsible Party
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Asan Medical Center
Principal Investigators
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Young Hee Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Young Hee Yoon, MD
Role: primary
Don-Il Ham, MD
Role: backup
Other Identifiers
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RTS-2008-1
Identifier Type: -
Identifier Source: org_study_id