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Safety and Efficacy of Fluocinolone Acetonide Intravitreal Implants

NCT ID: NCT00407082

Last Updated: 2011-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

278 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-12-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Noninfectious Posterior Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluocinolone acetonide 0.59mg

Fluocinolone acetonide ocular implant 0.59mg

Group Type EXPERIMENTAL

fluocinolone acetonide intravitreal implant

Intervention Type DRUG

Fluocinolone acetonide ocular implant 0.59mg

Fluocinolone acetonide 2.1mg

Fluocinolone acetonide ocular implant 2.1mg

Group Type EXPERIMENTAL

Fluocinolone acetonide 2.1mg

Intervention Type DRUG

Fluocinolone acetonide ocular implant 2.1mg

No intervention

Fellow eye

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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fluocinolone acetonide intravitreal implant

Fluocinolone acetonide ocular implant 0.59mg

Intervention Type DRUG

Fluocinolone acetonide 2.1mg

Fluocinolone acetonide ocular implant 2.1mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Coexisting medical or ocular conditions that would interfere with the study results
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas A Crescuillo

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Duke Eye Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 16690128 (View on PubMed)

Callanan 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.

Reference Type DERIVED
PMID: 18779477 (View on PubMed)

Other Identifiers

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415-001

Identifier Type: -

Identifier Source: org_study_id