UveitisPhase 4NCT00543296
Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
A Phase 4 study testing 0.59 mg Fluocinolone Acetonide implant in people with Uveitis, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Uveitis
- What is being tested?
- 0.59 mg Fluocinolone Acetonide implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Jul 2007
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Non-infectious intermediate, posterior or panuveitis
- Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug
Who cannot join
- Infectious uveitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Eye Center
Durham, North Carolina, 27710
About this study
The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.
Read the detailed description
Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant.
Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis
- Conditions
- Uveitis
- Being tested
- 0.59 mg Fluocinolone Acetonide implant
- Keywords
- uveitis, Cystoid Macular Edema (CME), fluocinolone acetonide, non-infectious uveitis affecting the posterior segment
- Medical subject headings
- Uveitis, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.59 mg Fluocinolone Acetonide implantDrug
Also called Retisert
0.59 mg Fluocinolone Acetonide implant
| Study group | Role | What they receive |
|---|---|---|
| 0.59 mg Fluocinolone Acetonide implant | Experimental | 0.59 mg Fluocinolone Acetonide implant Receives: Drug: 0.59 mg Fluocinolone Acetonide implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Eyes With Inflammation Recurrence
Number of eyes with inflammation recurrence
Measured: 5 years
Secondary outcomes (3)
Percentage of Eyes With Improvement in Visual Acuity
Visual acuity was improved by two or more lines from baseline.
Measured: baseline to 52 weeks
Number of Participant's Eye Requiring Adjunctive Therapy
Adjunctive Therapy needed to control inflammation in the implanted eye
Measured: 5 years
Number of Eyes With Increased Intraocular Pressure
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2007 (estimated)
- Study startMar 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UveitisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Sponsor
- Investigators
- Glenn J Jaffe, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00543296
- Sponsor's protocol ID
- Pro00013641
- Status last verified
- Jun 2014
- First submitted
- 11 Oct 2007
- Last updated
- 31 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-implantation of a Fluocinolone Acetonide Implant for Non-infectious Uveitis Affecting the Posterior Segment
- ClinicalTrials.gov ID
- NCT00543296
- Acronym / sponsor ID
- Pro00013641
- Conditions
- Uveitis
- Keywords
- uveitis, Cystoid Macular Edema (CME), fluocinolone acetonide, non-infectious uveitis affecting the posterior segment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Mar 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Oct 2007 (estimated)
- Results
- Posted 9 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to collect data on patients with severe uveitis that have required re-implantation of the sustained-release fluocinolone drug delivery device due to depletion of study drug in their previous implanted device.
Detailed description
Purpose: To collect medical information on a sustained release drug delivery system that delivers the corticosteroid, fluocinolone acetonide, directly into the vitreous cavity of the eye. This system has the potential to maintain therapeutic drug levels in the eye while reducing systemic exposure to the drug to negligible levels. RetisertTM is the trade name for the intravitreal fluocinolone acetonide implant.
Hypothesis: The RetisertTM will be a safe and effective method to manage patients with severe uveitis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.59 mg Fluocinolone Acetonide implant | Experimental | Drug: 0.59 mg Fluocinolone Acetonide implant0.59 mg Fluocinolone Acetonide implant |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Non-infectious intermediate, posterior or panuveitis
- Previous placement of fluocinolone acetonide implant with initial uveitis quiescence and subsequent recurrence of inflammation once implant depleted of drug
Key exclusion criteria (1 listed)
- Infectious uveitis
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 |
|---|---|---|
| 0.59 mg Fluocinolone Acetonide implantAlso: Retisert0.59 mg Fluocinolone Acetonide implant | Drug | 0.59 mg Fluocinolone Acetonide implant |
Primary outcome
Number of Eyes With Inflammation Recurrence
Time frame: 5 years
Number of eyes with inflammation recurrence
3 secondary outcomes
Percentage of Eyes With Improvement in Visual Acuity
Time frame: baseline to 52 weeks
Number of Participant's Eye Requiring Adjunctive Therapy
Time frame: 5 years
Number of Eyes With Increased Intraocular Pressure
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Glenn J Jaffe, MD principal investigator
Duke University
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 0.59 mg Fluocinolone Acetonide implant in people with Uveitis, run by Duke University at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 31 Mar 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Eyes With Inflammation Recurrence (time frame: 5 years). 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 31 Mar 2015.