CompletedNCT00468871Updated Dec 8, 2011

Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implant vs Standardized Therapy

A Phase 2/3 interventional study of fluocinolone acetonide intravitreal implant and corticosteroids and immunosuppressants in Non-infectious Uveitis, sponsored by Bausch & Lomb Incorporated. Completed. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2011-12-08.

Sponsored by Bausch & Lomb Incorporated (part of Bausch Health Companies Inc.) · Phase 2/3, Interventional, and Treatment

Phase: Phase 2/3
Study type: Interventional
Enrollment: 140
Allocation: Randomized
Ages: 6 Years and older
Sex: All

Study 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 the posterior segment of the eye.

Conditions studied

Non-infectious Uveitis

In context

Lead sponsor

Bausch & Lomb Incorporated is the lead sponsor of 223 studies on the registry; 5 are open to participants now.

Of its 51 completed or terminated interventional studies of FDA-regulated products, 41 (80%) have results posted.

First submitted before Bausch & Lomb Incorporated became part of Bausch Health Companies Inc..

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 6 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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
monocularity
AIDS
pregnancy/lactation
potential for noncompliance
or participation in other clinical studies within 1 month of enrollment.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 140 participants (actual)

Study arms

Experimental
Fluocinolone acetonide
Intravitreal fluocinolone acetonide implant
Drug: fluocinolone acetonide intravitreal implant
Active comparator
Standard care
Standard of Care
Drug: corticosteroids and immunosuppressants

Interventions

Drugfluocinolone acetonide intravitreal implant
surgical intravitreal implant of fluocinolone acetonide
Drugcorticosteroids and immunosuppressants
Drug page: Immunosuppressive Agents
Systemic corticosteroids alone or combined with immunosuppressants

What researchers measure

Primary outcomes

Time to first occurrence of uveitis in the study eye.
Time frame: 2 years

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

Study locations

No study locations are listed for this record.

References and documents

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 ↗
Pavesio 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 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2002, a primary completion of Jun 2006 and a completion of Jun 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: May 2, 2007
First posted: May 3, 2007
Start: Apr 2002
Primary completionActual: Jun 2006
CompletionActual: Jun 2006
Last update: Dec 8, 2011

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00468871
Lead sponsor: Bausch & Lomb Incorporated
Responsible party: Sponsor
First posted: May 3, 2007
Start date: Apr 2002
Primary completion: Jun 2006
Completion: Jun 2006
Last update: Dec 8, 2011

Study contacts

Carlos Pavesio, MD

principal investigator · Medical Retina Service/Moorfields Eye Hospital

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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