NCT00820014

Ocular Biodistribution Study for Topically Applied ESBA105

Evaluation of Tolerability, Safety and Ocular Pharmacokinetics of Topically Applied ESBA105 in Patients Undergoing Cataract Surgery or Combined Cataract Surgery and Vitrectomy

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: ESBATech AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Placebo	Placebo control (vehicle) eye drops applied 4-times a day for 4 days before ocular surgery

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2009-01-09
• Last updated: 2010-09-24

Locations

2 sites across 1 country: Switzerland