Ocular Biodistribution Study for Topically Applied ESBA105

• Status: Completed
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ESBATech AG

Criteria

Inclusion Criteria:

• Male or female Caucasian patients ≥18 years.

• Written informed consent prior to any study procedures including screening tests for eligibility.

• Patients should be in good health as determined by past medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening.

• Ability to administer eye drops (personally or administered by another person).

Cataract patients:

• Eligible for routine, uncomplicated senile cataract surgery.

Vitrectomy patients:

• Diagnosis of epiretinal fibroplasia requiring vitrectomy and cataract surgery.

Exclusion Criteria:

• Treated glaucoma / elevated intraocular pressure (IOP) requiring therapy.

• History of chronic or recurrent intraocular inflammatory disease.

• Uncontrolled diabetes mellitus (fasting blood glucose >15 mmol/L).

• Diabetic retinopathy with history of laser photocoagulation.

• Patients with a single eye or a pinholed visual acuity (VA) 20/200 or worse measured on Snellen chart in the non-study eye.

• Iris atrophy in the eye to undergo surgery.

• Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception

• History of collagenosis or systemic vasculitis.

• Patients who have had ocular surgery (including laser surgery) in the study eye within 3 months or in the contralateral eye within 2 weeks prior to screening.

• Patients who have an active systemic or local (anywhere in the body) bacterial and/or viral infection.

• Positive or unclear QuantiFERON-TB Gold assay result.

• Participation in a clinical study with investigational drugs within 3 months prior to screening.

• Inability to comply with the study requirements.

• Patients with known, severely impaired hepatic function, or laboratory values reflecting inadequate hepatic function.

• Patients with pre-existing chronic renal failure defined by a calculated creatinine clearance (CrCl) of < 40 mL/min, using the Cockcroft-Gault estimate for glomerular filtration rate