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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
ESBA105 eye drops (10mg/mL), initially applied in hourly dosing intervals, followed by later dose tapering (prolongation of dosing intervals)
Universitäts-Augenklinik
Tübingen, Baden-Würtemberg, Germany
Uveitis-Zentrum Franziskus Hospital
Münster, North Rhine-Westphalia, Germany
Charité Humboldt University
Berlin, State of Berlin, Germany
Changes in the level of intraocular inflammation (anterior chamber cell count according to SUN Working group criteria)
Time frame: 28 Days
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
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