Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

229

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2006

Typical duration for phase_2

Geographic Reach

17 countries

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

May 1, 2006

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

June 2, 2006

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2006

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed

2 years until next milestone

Results Posted

Study results publicly available

April 14, 2011

Completed

Last Updated

April 14, 2011

Status Verified

March 1, 2011

Enrollment Period

2.6 years

First QC Date

June 2, 2006

Results QC Date

October 12, 2010

Last Update Submit

March 11, 2011

Conditions

Intermediate Uveitis Posterior Uveitis

Outcome Measures

Primary Outcomes (1)

Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).
Week 8

Other Outcomes (2)

Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)
Week 8
Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score
Week 8

Study Arms (3)

1

ACTIVE COMPARATOR

Dexamethasone 350 µg

Drug: Dexamethasone

2

ACTIVE COMPARATOR

Dexamethasone 700 µg

Drug: dexamethasone

3

SHAM COMPARATOR

Sham

Drug: Sham injection

Interventions

dexamethasoneDRUG

Dexamethasone 350 µg; injection drug delivery system at Day 0

Also known as: Posurdex®

Sham injectionDRUG

Sham injection at Day 0

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Uncontrolled systemic disease
Any active ocular infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Allerganlead

Study Sites (18)

Unknown Facility

Dallas, Texas, United States

Location

Unknown Facility

Sydney, Australia

Location

Unknown Facility

Vienna, Austria

Location

Unknown Facility

São Paulo, São Paulo/SP, Brazil

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Heidelberg, Germany

Location

Unknown Facility

Cholargós, Greece

Location

Unknown Facility

Hyderabad, India

Location

Unknown Facility

Petah Tikva, Israel

Location

Unknown Facility

Gdansk, Poland

Location

Unknown Facility

Coimbra, Portugal

Location

Unknown Facility

Johannesburg, South Africa

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Lausanne, Switzerland

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (3)

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.
PMID: 23761087DERIVED
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.
PMID: 23411886DERIVED
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.
PMID: 21220619DERIVED

MeSH Terms

Conditions

Uveitis, IntermediateUveitis, Posterior

Interventions

Dexamethasonesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

UveitisUveal DiseasesEye DiseasesPanuveitis

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title: Therapeutic Area Head
Organization: Allergan, Inc

Study Officials

Medical Director
Allergan
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 6, 2006

Study Start

May 1, 2006

Primary Completion

December 1, 2008

Study Completion

April 1, 2009

Last Updated

April 14, 2011

Results First Posted

April 14, 2011

Record last verified: 2011-03

Locations

GB(1)AU(1)CZ(1)CA(1)PT(1)ES(1)US(1)ZA(1)FR(1)IL(1)KR(1)BR(1)CH(1)IN(1)DE(1)GR(1)PL(1)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Other Outcomes (2)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Other Outcomes (2)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (18)

Related Publications (3)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations