The purpose of this study is to determine whether ESBA105, a single-chain (scFv) antibody against TNF-alpha, efficiently penetrates into the anterior chamber and the vitreous body upon topical administration to the eye.
ESBA105 is a topically administered tumour necrosis factor alpha (TNF-alpha) inhibitor that has significant therapeutic potential in various inflammatory intraocular diseases. In animal experiments, ESBA105 was shown to efficiently penetrate into the inner of the eye upon topical administration, associated with very low systemic exposure. A recently completed Phase I trial with topical ESBA105 has confirmed the safety of topical administration to the human eye and the low systemic exposure using this route of administration. This study is designed to determine the intraocular levels and the specific intraocular distribution pattern of ESBA105 following topical administration to the human eye. In addition it shall be explored whether topical administration of ESBA105 reduces intraocular inflammation following cataract surgery. Three different dose regimens will be applied to four different patient cohorts. Three patient cohorts will be conducted in an open label design and one in a double-masked, placebo controlled design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
79
Placebo control (vehicle) eye drops applied 4-times a day for 4 days before ocular surgery
Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland
Lucerne, Canton of Lucerne, Switzerland
Pallas Gruppe
Olten, Canton of Solothurn, Switzerland
Determination of intraocular ESBA105 levels, local biodistribution (aqueous and vitreous humor) and intraocular pharmacokinetics upon topical administration.
Time frame: Collection of respective biological matrices at occasion of ocular surgery
Exploratory assessment of the anti-inflammatory potential of prophylactic, topical ESBA105 for prevention of post-surgical inflammation following cataract surgery.
Time frame: 10 Days following ocular surgery
Assessment of local tolerability and safety of topical ESBA105.
Time frame: up to 10 Days following ocular surgery
Assessment of systemic exposure upon topical application of ESBA105.
Time frame: 1 Day following ocular surgery
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