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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00333814
First Posted: June 6, 2006
Last Update Posted: April 14, 2011
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.
Information provided by:
Allergan
  Purpose
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 Intervention Phase
Intermediate Uveitis Posterior Uveitis Drug: Dexamethasone Drug: dexamethasone Drug: Sham injection Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • 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).


Enrollment: 229
Study Start Date: May 2006
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Sham
Drug: Sham injection
Sham injection at Day 0

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00333814


  Show 18 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00333814     History of Changes
Other Study ID Numbers: 206207-014
First Submitted: June 2, 2006
First Posted: June 6, 2006
Results First Submitted: October 12, 2010
Results First Posted: April 14, 2011
Last Update Posted: April 14, 2011
Last Verified: March 2011

Additional relevant MeSH terms:
Uveitis
Uveitis, Posterior
Uveitis, Intermediate
Pars Planitis
Uveal Diseases
Eye Diseases
Panuveitis
Choroiditis
Choroid Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action