Non-infectious UveitisPhase 2/3NCT00468871
Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy
A Phase 2/3 study testing fluocinolone acetonide intravitreal implant and corticosteroids and immunosuppressants in people with Non-infectious Uveitis, run by Bausch & Lomb Incorporated.
Trial summary
This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting… 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 intravitreal implant and corticosteroids and immunosuppressants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Apr 2002to Jun 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 and non-pregnant females at least 6 years of age
- History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease
- The more severely affected eye having had at least 2 separate recurrences
- The more severely affected eye having been treated by systemic therapy for at least one month just before inclusion
- Visual acuity (VA) of at least 1.4 logMAR units at enrollment
- At time of enrollment, </=10 anterior chamber cells/HPF and vitrous haze</= grade 2.
Who cannot join
- known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered
- history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous
- presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP >25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to <25 mm Hg
- history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze
- infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye
- ocular surgery and/or trauma on the study eye within 3 months prior to enrollment, or trabeculoplasty or yttrium aluminum garnet laser within 1 month prior to study enrollment
Show all 11Show fewer
- monocularity
- AIDS
- pregnancy/lactation
- potential for noncompliance
- or participation in other clinical studies within 1 month of enrollment.
About this study
Official title: A Multicenter, Randomized, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
This is a 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.
- Conditions
- Non-infectious Uveitis
- Being tested
- fluocinolone acetonide intravitreal implant, corticosteroids and immunosuppressants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluocinolone acetonide intravitreal implantDrug
surgical intravitreal implant of fluocinolone acetonide
corticosteroids and immunosuppressantsDrug
Systemic corticosteroids alone or combined with immunosuppressants
| Study group | Role | What they receive |
|---|---|---|
| Fluocinolone acetonide | Experimental | Intravitreal fluocinolone acetonide implant Receives: Drug: fluocinolone acetonide intravitreal implant |
| Standard care | Active comparator | Standard of Care Receives: Drug: corticosteroids and immunosuppressants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of uveitis in the study eye.
Measured: 2 years
Secondary outcomes (8)
The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.
Measured: 33 months
Number of recurrences
Measured: 33 months
Number of recurrences compared to the 52 weeks prior to enrollment
Measured: 33 months
Change in quality of life indices
Measured: 33 months
Adjunctive treatment required
Measured: 33 months
Change in the size, if present at baseline, of the area of CME on fluorescein angiography
Measured: 33 months
Analysis of safety variables
Measured: 33 months
Percent of subjects who had at least one recurrence
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2007 (estimated)
- Study startApr 2002
- Primary completionJun 2006
- Study completionJun 2006
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 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
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlos Pavesio, MD, Principal investigator, Medical Retina Service/Moorfields Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468871
- Sponsor's protocol ID
- 415-002
- Status last verified
- Dec 2011
- First submitted
- 2 May 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 16690128Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW; Fluocinolone Acetonide Study Group. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010 Mar;117(3):567-75, 575.e1. doi: 10.1016/j.ophtha.2009.11.027. Epub 2010 Jan 15.
PubMed 20079922
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, Controlled Study to Evaluate the Safety and Efficacy of an Intravitreal Fluocinolone Acetonide (0.5mg) Implant Compared to Standardized Therapy in Subjects With Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
- ClinicalTrials.gov ID
- NCT00468871
- Acronym / sponsor ID
- 415-002
- Conditions
- Non-infectious Uveitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2002
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 3 May 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 3 year,superiority, multicenter, open-label, randomised controlled safety and efficacy study. The aim of this study is to evaluate the effect of an intravitreal fluocinolone acetonide (0.59 mg) implant compared to standardized therapy in subjects with unilateral or bilateral, non-infectious uveitis affecting the posterior segment of the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluocinolone acetonide | Experimental | Drug: fluocinolone acetonide intravitreal implantIntravitreal fluocinolone acetonide implant |
| Standard care | Active comparator | Drug: corticosteroids and immunosuppressantsStandard of Care |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Males and non-pregnant females at least 6 years of age
- History of recurrent unilateral or asymmetric non-infectious posterior uveitis of at east 1 year duration not associated with significant systemic activity of the disease
- The more severely affected eye having had at least 2 separate recurrences
- The more severely affected eye having been treated by systemic therapy for at least one month just before inclusion
- Visual acuity (VA) of at least 1.4 logMAR units at enrollment
Key exclusion criteria (11 listed)
- known allergy or contraindication to fluocinolone acetonide, systemic corticosteroids, or the immunosuppressive agents to be administered
- history of retinal detachment, retinoschisis in the area of implantation, or media opacity precluding evaluation of the retina and vitreous
- presence or history of uncontrolled IOP while on steroid therapy resulting in loss of vision, or IOP >25 mm Hg requiring at least 2 types of antiglaucoma medication to be reduced to <25 mm Hg
- history of NIPU only or iritis only with no vitritis, macular edema, vitreous cells, or vitreous haze
- infectious etiology, vitreous hemorrhage, or a toxoplasma scar in the study eye
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 implantsurgical intravitreal implant of fluocinolone acetonide | Drug | Fluocinolone acetonide |
| corticosteroids and immunosuppressantsSystemic corticosteroids alone or combined with immunosuppressants | Drug | Standard care |
Primary outcome
Time to first occurrence of uveitis in the study eye.
Time frame: 2 years
8 secondary outcomes
The proportion of subjects with a visual acuity improvement of more than 15 letters on ETDRS charts from baseline.
Time frame: 33 months
Number of recurrences
Time frame: 33 months
Number of recurrences compared to the 52 weeks prior to enrollment
Time frame: 33 months
Change in quality of life indices
Time frame: 33 months
Adjunctive treatment required
Time frame: 33 months
Change in the size, if present at baseline, of the area of CME on fluorescein angiography
Time frame: 33 months
Analysis of safety variables
Time frame: 33 months
Percent of subjects who had at least one recurrence
Time frame: 33 months
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.
- 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.
- Derived from this study: PubMed 20079922Pavesio C, Zierhut M, Bairi K, Comstock TL, Usner DW; Fluocinolone Acetonide Study Group. Evaluation of an intravitreal fluocinolone acetonide implant versus standard systemic therapy in noninfectious posterior uveitis. Ophthalmology. 2010 Mar;117(3):567-75, 575.e1. doi: 10.1016/j.ophtha.2009.11.027. Epub 2010 Jan 15.
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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.
Carlos Pavesio, MD principal investigator
Medical Retina Service/Moorfields Eye Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing fluocinolone acetonide intravitreal implant and corticosteroids and immunosuppressants 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 6 inclusion and 11 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.
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?
Time to first occurrence of uveitis in the study eye. (time frame: 2 years). 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 NCT00468871, 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.