Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease

Non-Infectious Uveitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00720928
• Other study ID #: RTS-2008-1
• Status: Recruiting
• Phase: Phase 4
• First received: July 18, 2008
• Last updated: July 28, 2008
• Start date: July 2008
• Est. completion date: May 2010

Study information

• Verified date: July 2008
• Source: Asan Medical Center
• Contact: Young Hee Yoon, MD
• Phone: 822-3010-3675
• Email: yhyoon[@]amc.seoul.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Asan Medical Center	Kyunghee University Medical Center, Samsung Medical Center, Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		1 year	Yes
Secondary	Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc.		1 year	Yes