Clinical Trial: Exploratory Study on Topical ESBA105 in Acute Anterior Uveitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label Exploratory Study to Assess the Safety, Tolerability and Clinical Activity of Topically Applied ESBA105 in Patients With Acute Anterior Uveitis

Brief Summary: The purpose of this study is to determine whether ESBA105, a topically applied TNF-alpha inhibitor, is safe and clinically active when applied to the eye of patients suffering from acute anterior uveitis

Detailed Summary:

Acute anterior uveitis (AAU) is a common, recurrent disease characterized by inflammation of the iris and ciliary body. Though usually effectively treated by topical corticosteroids, novel treatment modalities are required to overcome the limitations and adverse effect problems associated with the use of corticosteroids. TNF-alpha has been recognized as a central disease mediator in AAU, as shown by preclinical models and clinical data with systemically applied TNF-alpha inhibitors.

ESBA105 is a topically applied TNF-alpha inhibitor that is characterized by efficient penetration into the eye resulting in high intraocular drug levels. A recently completed Phase I trial confirmed that safety and tolerability of topical ESBA105 in healthy individuals is excellent and systemic exposure is low.

In this pilot trial, the safety, local tolerability and clinical activity of topical ESBA105 in the treatment of patients with acute anterior uveitis shall be explored.


Sponsor: ESBATech AG

Current Primary Outcome: Changes in the level of intraocular inflammation (anterior chamber cell count according to SUN Working group criteria) [ Time Frame: 28 Days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Nature and incidence of adverse events, physical and ophthalmological findings and laboratory test results [ Time Frame: 28 Days ]
  • Systemic exposure to study drug [ Time Frame: 28 Days ]
  • Changes in disease severity as assessed by visual analogue scale (VAS) [ Time Frame: 28 Days ]


Original Secondary Outcome: Same as current

Information By: ESBATech AG

Dates:
Date Received: January 14, 2009
Date Started: January 2009
Date Completion:
Last Updated: May 25, 2011
Last Verified: September 2010