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Completed

NCT Number: NCT00333814

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

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

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Key information

Conditions

Intermediate Uveitis Eye Diseases Panuveitis Posterior Uveitis Uveal Diseases Uveitis Uveitis, Intermediate Uveitis, Posterior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Sydney, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Dexamethasone 350 µg; injection drug delivery system at Day 0

Other names: Posurdex®

Sham injection

Drug

Sham injection at Day 0

Primary outcomes

  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).

Other outcomes

  1. Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)

    Time frame: Week 8

    Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.

  2. Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score

    Time frame: Week 8

    Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jun 6, 2006
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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