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

Allergan229 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

229

Conditions

Intermediate Uveitis Posterior Uveitis

Interventions

DexamethasoneDRUG

Dexamethasone 350 µg; injection drug delivery system at Day 0

dexamethasoneDRUG

Dexamethasone 700 µg injection drug delivery system at Day 0

Sham injectionDRUG

Sham injection at Day 0

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Unnamed facility

Dallas, Texas, United States

Unnamed facility

Sydney, Australia

Unnamed facility

Vienna, Austria

Outcomes

Primary Outcomes

Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero

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).

Time frame: Week 8

Data from ClinicalTrials.gov

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