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Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease

Primary Purpose

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

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
flucinolone acetonide
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ocular Behcet's Disease, focused on measuring Behcet's disease, posterior uveitis, flucinolone acetonide, RETISERT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single group

Arm Description

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).

Outcomes

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

Secondary Outcome Measures

Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc.

Full Information

First Posted
July 18, 2008
Last Updated
July 28, 2008
Sponsor
Asan Medical Center
Collaborators
Samsung Medical Center, Seoul National University Hospital, Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00720928
Brief Title
Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Asan Medical Center
Collaborators
Samsung Medical Center, Seoul National University Hospital, Kyunghee University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Behcet's Disease,, Non-Infectious Uveitis, Refractory Uveitis
Keywords
Behcet's disease, posterior uveitis, flucinolone acetonide, RETISERT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single group
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
flucinolone acetonide
Other Intervention Name(s)
RETISERT
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young Hee Yoon, MD
Phone
822-3010-3675
Email
yhyoon@amc.seoul.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Don-Il Ham, MD
Phone
822-3410-3567
Email
diham@smc.samsung.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Hee Yoon, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Hee Yoon, MD
Phone
822-3010-3680
Email
yhyoon@amc.seoul.kr
First Name & Middle Initial & Last Name & Degree
Don-Il Ham, MD
Phone
822-3410-3567
Email
diham@smc.samsung.co.kr

12. IPD Sharing Statement

Learn more about this trial

Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease

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