Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Samsung Medical Center
Seoul National University Hospital
Kyunghee University Medical Center
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00720928
First received: July 18, 2008
Last updated: July 28, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Ocular Behcet's Disease,
Non-Infectious Uveitis
Refractory Uveitis
Drug: flucinolone acetonide
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
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)
Arms Assigned Interventions
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).

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and non-pregnant females at least 18 years of age having complete or incomplete type of Behcet's disease according to the revised diagnostic criteria proposed by the Behcet's Disease Research Committee of Japan in 2003; typical ocular lesion and at least, one of the main symptoms or two of the additional symptoms.
  • 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:

  • Allergy to FA or any component of the delivery system
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720928

Contacts
Contact: Young Hee Yoon, MD 822-3010-3675 yhyoon@amc.seoul.kr
Contact: Don-Il Ham, MD 822-3410-3567 diham@smc.samsung.co.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Young Hee Yoon, MD    822-3010-3680    yhyoon@amc.seoul.kr   
Contact: Don-Il Ham, MD    822-3410-3567    diham@smc.samsung.co.kr   
Sponsors and Collaborators
Asan Medical Center
Samsung Medical Center
Seoul National University Hospital
Kyunghee University Medical Center
Investigators
Principal Investigator: Young Hee Yoon, MD Asan Medical Center
  More Information

No publications provided

Responsible Party: Young Hee Yoon, MD/Professor and Chairman, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00720928     History of Changes
Other Study ID Numbers: RTS-2008-1
Study First Received: July 18, 2008
Last Updated: July 28, 2008
Health Authority: Korea: Food and Drug Administration

Keywords provided by Asan Medical Center:
Behcet's disease
posterior uveitis
flucinolone acetonide
RETISERT

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Retinal Diseases
Choroid Diseases
Uveitis
Chorioretinitis
Uveitis, Anterior
Panuveitis
Vasculitis
Retinitis
Choroiditis
Uveitis, Posterior
Fluocinolone Acetonide
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014