Noninfectious Posterior UveitisPhase 2/3NCT00407082
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants
A Phase 2/3 study testing fluocinolone acetonide intravitreal implant and Fluocinolone acetonide 2.1mg in people with Noninfectious Posterior Uveitis, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
This is a multi-center, randomized, double-masked, controlled study to evaluate the safety and efficacy of fluocinolone acetonide (FA) 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
- Noninfectious Posterior Uveitis
- What is being tested?
- fluocinolone acetonide intravitreal implant and Fluocinolone acetonide 2.1mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2000to Sep 2005
- 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, and had 'quiet' eyes at surgery
Who cannot join
- Coexisting medical or ocular conditions that would interfere with the study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Masked, Controlled Study to Evaluate the Safety & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) 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 (FA) 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
- Noninfectious Posterior Uveitis
- Being tested
- fluocinolone acetonide intravitreal implant, 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 intravitreal implantDrug
Fluocinolone acetonide ocular implant 0.59mg
Fluocinolone acetonide 2.1mgDrug
Fluocinolone acetonide ocular implant 2.1mg
| Study group | Role | What they receive |
|---|---|---|
| Fluocinolone acetonide 0.59mg | Experimental | Fluocinolone acetonide ocular implant 0.59mg Receives: Drug: fluocinolone acetonide intravitreal implant |
| Fluocinolone acetonide 2.1mg | Experimental | Fluocinolone acetonide ocular 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.
Measured: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation
Secondary outcomes (8)
Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.
Measured: 34 weeks, 1 year, 2 years and 3 years post-implantation
Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes.
Measured: 34 weeks, 1 year, 2 years and 3 years post-implantation
The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation)
Measured: 34 weeks, 1 year, 2 years and 3 years post-implantation
Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes)
Measured: 34 weeks, 1 year, 2 years and 3 years post-implantation
Results of QOL surveys pre- versus post-implantation
Measured: 34 weeks, 1 year, 2 years and 3 years post-implantation
Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes)
Measured: 34 weeks, 1 year, 2 years and 3 years post-implantation
Time to recurrence, between treatment group comparison
Measured: 34 weeks, 1 year, 2 years and 3 years post-implantation
Post implantation uveitis rate, between treatment group comparison
Measured: 34 weeks, 1 year, 2 years and 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 posted4 Dec 2006 (estimated)
- Study startDec 2000
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Noninfectious Posterior 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
- Who is masked
- Participant, Investigator
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas A Crescuillo, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407082
- Sponsor's protocol ID
- 415-001
- Status last verified
- Dec 2011
- First submitted
- 1 Dec 2006
- Last updated
- 8 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
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 16690128Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008 Sep;126(9):1191-201. doi: 10.1001/archopht.126.9.1191.
PubMed 18779477
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 & Efficacy of Intravitreal Fluocinolone Acetonide (0.59 or 2.1 mg) Implant in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
- ClinicalTrials.gov ID
- NCT00407082
- Acronym / sponsor ID
- 415-001
- Conditions
- Noninfectious Posterior Uveitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 4 Dec 2006 (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 (FA) 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 (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluocinolone acetonide 0.59mg | Experimental | Drug: fluocinolone acetonide intravitreal implantFluocinolone acetonide ocular implant 0.59mg |
| Fluocinolone acetonide 2.1mg | Experimental | Drug: Fluocinolone acetonide 2.1mgFluocinolone acetonide ocular 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 (1 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, and had 'quiet' eyes at surgery
Key exclusion criteria (1 listed)
- Coexisting medical or ocular conditions that would interfere with the study results
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 intravitreal implantFluocinolone acetonide ocular implant 0.59mg | Drug | Fluocinolone acetonide 0.59mg |
| Fluocinolone acetonide 2.1mgFluocinolone acetonide ocular implant 2.1mg | Drug | Fluocinolone acetonide 2.1mg |
Primary outcome
Recurrence of uveitis before and after implantation.
Time frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 3 years post-implantation
8 secondary outcomes
Post-implantation rate of uveitis recurrence, within patient comparison of implanted vs fellow eyes.
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Post-implantation time to recurrence of uveitis within patient comparison of implanted vs fellow eyes.
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
The need for adjunctive uveitis treatment for the study eye, within patient comparison (pre- versus post-implantation)
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Reduction in the area of cystoid macular edema (CME) within patient comparison of responding eyes (implant vs fellow eyes)
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Results of QOL surveys pre- versus post-implantation
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Visual acuity, within patient comparison of responding eyes (implant vs fellow eyes)
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Time to recurrence, between treatment group comparison
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Post implantation uveitis rate, between treatment group comparison
Time frame: 34 weeks, 1 year, 2 years and 3 years post-implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
- Results publication: 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.
- Derived from this study: PubMed 18779477Callanan DG, Jaffe GJ, Martin DF, Pearson PA, Comstock TL. Treatment of posterior uveitis with a fluocinolone acetonide implant: three-year clinical trial results. Arch Ophthalmol. 2008 Sep;126(9):1191-201. doi: 10.1001/archopht.126.9.1191.
Related trials for Noninfectious Posterior Uveitis
Not yet recruitingPhase 2
A Clinical Trial Of Tulisokibart In Participants With Active, Non-Infectious Uveitis (MK-7240-019)
Noninfectious Intermediate, Posterior, or Panuveitis
Not yet recruitingObservational study
Frequency and Intensity of Inflammatory Relapses in Patients With Non-infectious Posterior Uveitis Treated With a Fluocinolone Acetonide Implant
Noninfectious Posterior Uveitis, Uveitis, Posterior
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.
Thomas A Crescuillo study director
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fluocinolone acetonide intravitreal implant and Fluocinolone acetonide 2.1mg in people with Noninfectious Posterior Uveitis, run by Bausch & Lomb Incorporated 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 1 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 8 Dec 2011. 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. (time frame: 34 weeks pre-implantation; 34 weeks, 1 year, 2 years and 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 NCT00407082, which also lists 2 linked publications.
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.