Non-infectious UveitisPhase 2/3NCT00456482
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant
A Phase 2/3 study testing Fluocinolone Acetonide 0.59mg and Fluocinolone Acetonide 2.1mg in people with Non-infectious Uveitis, run by Bausch & Lomb Incorporated.
Trial summary
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Non-infectious Uveitis
- What is being tested?
- Fluocinolone Acetonide 0.59mg and Fluocinolone Acetonide 2.1mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- May 2002to Apr 2006
- Phase
- Phase 2/3
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,
- Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,
- Had clinically 'quiet' eyes at surgery.
Who cannot join
- Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.
About this study
Official title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.
- Conditions
- Non-infectious Uveitis
- Being tested
- Fluocinolone Acetonide 0.59mg, Fluocinolone Acetonide 2.1mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinolone Acetonide 0.59mgDrug
Fluocinolone Acetonide Intravitreal Implant 0.59 mg
Fluocinolone Acetonide 2.1mgDrug
Fluocinolone Acetonide Intravitreal Implant 2.1 mg
| Study group | Role | What they receive |
|---|---|---|
| Fluocinolone Acetonide 0.59mg | Experimental | Fluocinolone acetonide intravitreal implant 0.59mg Receives: Drug: Fluocinolone Acetonide 0.59mg |
| Fluocinolone Acetonide 2.1mg | Experimental | Fluocinolone acetonide intravitreal implant 2.1mg Receives: Drug: Fluocinolone Acetonide 2.1mg |
| No Intervention | No intervention | Fellow eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.
Measured: 1 year pre-implantation; 3 years post-implantation
Secondary outcomes (1)
Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys.
Measured: 1 year pre-implantation; 3 years post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startMay 2002
- Primary completionApr 2006
- Study completionApr 2006
Why it stopped: SARS epidemic in Asia and Canada
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-infectious UveitisStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy L Comstock, OD, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456482
- Sponsor's protocol ID
- 415-004
- Status last verified
- Dec 2011
- First submitted
- 3 Apr 2007
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
PubMed 16690128
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
- ClinicalTrials.gov ID
- NCT00456482
- Acronym / sponsor ID
- 415-004
- Conditions
- Non-infectious Uveitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: SARS epidemic in Asia and Canada
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 5 Apr 2007 (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.
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide intravitreal implants for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. An additional objective is to compare the safety and efficacy of two doses of fluocinolone acetonide.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluocinolone Acetonide 0.59mg | Experimental | Drug: Fluocinolone Acetonide 0.59mgFluocinolone acetonide intravitreal implant 0.59mg |
| Fluocinolone Acetonide 2.1mg | Experimental | Drug: Fluocinolone Acetonide 2.1mgFluocinolone acetonide intravitreal implant 2.1mg |
| No Intervention | No intervention | –Fellow eye |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Males or non-pregnant females at least 6 years of age who had been diagnosed and treated for recurrent,
- Non-infectious uveitis affecting the posterior segment of one or both eyes for at least 1 year prior to the start of the study,
- Had clinically 'quiet' eyes at surgery.
Key exclusion criteria (1 listed)
- Coexistent medical or ocular conditions that would interfere with obtaining or interpreting data for this study.
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 |
|---|---|---|
| Fluocinolone Acetonide 0.59mgFluocinolone Acetonide Intravitreal Implant 0.59 mg | Drug | Fluocinolone Acetonide 0.59mg |
| Fluocinolone Acetonide 2.1mgFluocinolone Acetonide Intravitreal Implant 2.1 mg | Drug | Fluocinolone Acetonide 2.1mg |
Primary outcome
Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye.
Time frame: 1 year pre-implantation; 3 years post-implantation
1 secondary outcome
Between-dose group and within-subject comparisons (Study to Fellow eye) for uveitis recurrence; time to first recurrence; need for adjunctive uveitis treatment; reduction in the area of cystoid macular edema; results of quality of life surveys.
Time frame: 1 year pre-implantation; 3 years post-implantation
Results and safety
The study was stopped early (reason given: SARS epidemic in Asia and Canada). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Background: PubMed 16690128Jaffe GJ, Martin D, Callanan D, Pearson PA, Levy B, Comstock T; Fluocinolone Acetonide Uveitis Study Group. Fluocinolone acetonide implant (Retisert) for noninfectious posterior uveitis: thirty-four-week results of a multicenter randomized clinical study. Ophthalmology. 2006 Jun;113(6):1020-7. doi: 10.1016/j.ophtha.2006.02.021. Epub 2006 May 9.
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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.
Timothy L Comstock, OD study director
Bausch & Lomb Incorporated
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fluocinolone Acetonide 0.59mg and Fluocinolone Acetonide 2.1mg in people with Non-infectious Uveitis, run by Bausch & Lomb Incorporated.
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 3 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: stopped early, as of the sponsor's last update on 8 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: SARS epidemic in Asia and Canada). Results are not available in the source record.
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?
Recurrence of uveitis before and after implantation. Postimplantation recurrences were evaluated using protocol-defined criteria based upon changes in VA, vitreous haze, and the presence of cells in the anterior chamber of the eye. (time frame: 1 year pre-implantation; 3 years post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00456482, which also lists 1 linked publication.
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 8 Dec 2011.