Ocular Behcet's Disease,Phase 4NCT00720928
Flucinolone Acetonide Implant for Treating Refractory Ocular Behcet's Disease
A Phase 4 study testing flucinolone acetonide in people with Ocular Behcet's Disease, and Non-Infectious Uveitis, run by Asan Medical Center at 1 site in South Korea.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Behcet's Disease,, Non-Infectious Uveitis, Refractory Uveitis
- What is being tested?
- flucinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to May 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Young Hee Yoon, MD, 822-3010-3680, yhyoon@amc.seoul.kr
Don-Il Ham, MD, 822-3410-3567, diham@smc.samsung.co.kr
About this study
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
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
Read the 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.
- Being tested
- flucinolone acetonide
- Keywords
- Behcet's disease, posterior uveitis, flucinolone acetonide, RETISERT
- Medical subject headings
- Uveitis, Behcet Syndrome, Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flucinolone acetonideDrug
Also called RETISERT
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.
| Study group | Role | What they receive |
|---|---|---|
| single group | Other | 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). Receives: Drug: flucinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (1)
Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionDec 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Behcet's Disease,Studies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Seoul National University Hospital, Kyunghee University Medical Center
- Investigators
- Young Hee Yoon, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720928
- Sponsor's protocol ID
- RTS-2008-1
- Status last verified
- Jul 2008
- First submitted
- 18 Jul 2008
- Last updated
- 29 Jul 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00720928
- Acronym / sponsor ID
- RTS-2008-1
- Keywords
- Behcet's disease, posterior uveitis, flucinolone acetonide, RETISERT
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Seoul National University Hospital, Kyunghee University Medical Center
- Study start
- Jul 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 23 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single group | Other | Drug: flucinolone acetonidePosterior 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flucinolone acetonideAlso: RETISERTIntra-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. | Drug | single group |
Primary outcome
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 secondary outcome
Post-implantation recurrence of uveitis rate: within-patient comparison of responding eyes (implant vs. fellow)and etc.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young Hee Yoon, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing flucinolone acetonide in people with Ocular Behcet's Disease, and Non-Infectious Uveitis, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Young Hee Yoon, MD (822-3010-3675, yhyoon@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2008.