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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00333814
First received: June 2, 2006
Last updated: March 11, 2011
Last verified: March 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333814

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

Additional Information:
No publications provided by Allergan

Additional 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
Study First Received: June 2, 2006
Results First Received: October 12, 2010
Last Updated: March 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chorioretinitis
Pars Planitis
Uveitis
Uveitis, Intermediate
Uveitis, Posterior
Choroid Diseases
Choroiditis
Eye Diseases
Panuveitis
Retinal Diseases
Retinitis
Uveal Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 23, 2014