Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease

July 28, 2008 updated by: Asan Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Names:
  • RETISERT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Collaborators

Samsung Medical Center
Seoul National University Hospital
Kyunghee University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

May 1, 2010

Study Registration Dates

First Submitted

July 18, 2008

First Submitted That Met QC Criteria

July 21, 2008

First Posted (Estimate)

July 23, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2008

Last Update Submitted That Met QC Criteria

July 28, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTS-2008-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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