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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00333814




Registration number
NCT00333814
Ethics application status
Date submitted
2/06/2006
Date registered
6/06/2006
Date last updated
14/04/2011

Titles & IDs
Public title
A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Intermediate or Posterior Uveitis
Scientific title
Secondary ID [1] 0 0
206207-014
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intermediate Uveitis 0 0
Posterior Uveitis 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dexamethasone
Treatment: Drugs - dexamethasone
Treatment: Drugs - Sham injection

Active comparator: 1 - Dexamethasone 350 µg

Active comparator: 2 - Dexamethasone 700 µg

Sham comparator: 3 - Sham


Treatment: Drugs: Dexamethasone
Dexamethasone 350 µg; injection drug delivery system at Day 0

Treatment: Drugs: dexamethasone
Dexamethasone 700 µg injection drug delivery system at Day 0

Treatment: Drugs: Sham injection
Sham injection at Day 0
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
Timepoint [1] 0 0
Week 8

Eligibility
Key inclusion criteria
* 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Uncontrolled systemic disease
* Any active ocular infections

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
229
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas
Country [2] 0 0
Austria
State/province [2] 0 0
Vienna
Country [3] 0 0
Brazil
State/province [3] 0 0
São Paulo/SP
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Czech Republic
State/province [5] 0 0
Prague
Country [6] 0 0
France
State/province [6] 0 0
Paris
Country [7] 0 0
Germany
State/province [7] 0 0
Heidelberg
Country [8] 0 0
Greece
State/province [8] 0 0
Holargos
Country [9] 0 0
India
State/province [9] 0 0
Hyderabad
Country [10] 0 0
Israel
State/province [10] 0 0
Petah Tikva
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Seoul
Country [12] 0 0
Poland
State/province [12] 0 0
Gdansk
Country [13] 0 0
Portugal
State/province [13] 0 0
Coimbra
Country [14] 0 0
South Africa
State/province [14] 0 0
Johannesburg
Country [15] 0 0
Spain
State/province [15] 0 0
Madrid
Country [16] 0 0
Switzerland
State/province [16] 0 0
Lausanne
Country [17] 0 0
United Kingdom
State/province [17] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00333814
Trial related presentations / publications
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.
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00333814