A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis

NCT ID: NCT00333814

Last Updated: 2011-04-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-04-30

Brief Summary

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This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.

Detailed Description

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Conditions

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Intermediate Uveitis Posterior Uveitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Dexamethasone 350 µg

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

Dexamethasone 350 µg; injection drug delivery system at Day 0

2

Dexamethasone 700 µg

Group Type ACTIVE_COMPARATOR

dexamethasone

Intervention Type DRUG

Dexamethasone 700 µg injection drug delivery system at Day 0

3

Sham

Group Type SHAM_COMPARATOR

Sham injection

Intervention Type DRUG

Sham injection at Day 0

Interventions

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Dexamethasone

Dexamethasone 350 µg; injection drug delivery system at Day 0

Intervention Type DRUG

dexamethasone

Dexamethasone 700 µg injection drug delivery system at Day 0

Intervention Type DRUG

Sham injection

Sham injection at Day 0

Intervention Type DRUG

Other Intervention Names

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Posurdex® Posurdex®

Eligibility Criteria

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Inclusion Criteria

* 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye

Exclusion Criteria

* Uncontrolled systemic disease
* Any active ocular infections
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Allergan, Inc.

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Dallas, Texas, United States

Site Status

Sydney, , Australia

Site Status

Vienna, , Austria

Site Status

São Paulo, São Paulo/SP, Brazil

Site Status

Montreal, Quebec, Canada

Site Status

Prague, , Czechia

Site Status

Paris, , France

Site Status

Heidelberg, , Germany

Site Status

Cholargós, , Greece

Site Status

Hyderabad, , India

Site Status

Petah Tikva, , Israel

Site Status

Gdansk, , Poland

Site Status

Coimbra, , Portugal

Site Status

Johannesburg, , South Africa

Site Status

Seoul, , South Korea

Site Status

Madrid, , Spain

Site Status

Lausanne, , Switzerland

Site Status

London, , United Kingdom

Site Status

Countries

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United States Australia Austria Brazil Canada Czechia France Germany Greece India Israel Poland Portugal South Africa South Korea Spain Switzerland United Kingdom

References

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Lightman S, Belfort R Jr, Naik RK, Lowder C, Foster CS, Rentz AM, Cui H, Whitcup SM, Kowalski JW, Revicki DA. Vision-related functioning outcomes of dexamethasone intravitreal implant in noninfectious intermediate or posterior uveitis. Invest Ophthalmol Vis Sci. 2013 Jul 18;54(7):4864-70. doi: 10.1167/iovs.12-10981.

Reference Type DERIVED
PMID: 23761087 (View on PubMed)

Naik RK, Rentz AM, Foster CS, Lightman S, Belfort R Jr, Lowder C, Whitcup SM, Kowalski JW, Revicki DA. Normative comparison of patient-reported outcomes in patients with noninfectious uveitis. JAMA Ophthalmol. 2013 Feb;131(2):219-25. doi: 10.1001/2013.jamaophthalmol.102.

Reference Type DERIVED
PMID: 23411886 (View on PubMed)

Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.

Reference Type DERIVED
PMID: 21220619 (View on PubMed)

Related Links

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Other Identifiers

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206207-014

Identifier Type: -

Identifier Source: org_study_id

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