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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00333814
Recruitment Status : Completed
First Posted : June 6, 2006
Results First Posted : April 14, 2011
Last Update Posted : April 14, 2011
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Intermediate Uveitis Posterior Uveitis Drug: Dexamethasone Drug: dexamethasone Drug: Sham injection Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : May 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009

Arm Intervention/treatment
Active Comparator: 1
Dexamethasone 350 µg
Drug: Dexamethasone
Dexamethasone 350 µg; injection drug delivery system at Day 0
Other Name: Posurdex®

Active Comparator: 2
Dexamethasone 700 µg
Drug: dexamethasone
Dexamethasone 700 µg injection drug delivery system at Day 0
Other Name: Posurdex®

Sham Comparator: 3
Drug: Sham injection
Sham injection at Day 0

Primary Outcome Measures :
  1. Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero [ Time Frame: Week 8 ]
    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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00333814

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United States, Texas
Dallas, Texas, United States
Sydney, Australia
Vienna, Austria
São Paulo, São Paulo/SP, Brazil
Canada, Quebec
Montreal, Quebec, Canada
Czech Republic
Prague, Czech Republic
Paris, France
Heidelberg, Germany
Holargos, Greece
Hyderabad, India
Petah Tikva, Israel
Korea, Republic of
Seoul, Korea, Republic of
Gdansk, Poland
Coimbra, Portugal
South Africa
Johannesburg, South Africa
Madrid, Spain
Lausanne, Switzerland
United Kingdom
London, United Kingdom
Sponsors and Collaborators
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Study Director: Medical Director Allergan

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Therapeutic Area Head, Allergan, Inc. Identifier: NCT00333814    
Other Study ID Numbers: 206207-014
First Posted: June 6, 2006    Key Record Dates
Results First Posted: April 14, 2011
Last Update Posted: April 14, 2011
Last Verified: March 2011
Additional relevant MeSH terms:
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Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Choroid Diseases
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action