Status:
COMPLETED
Ocular Biodistribution Study for Topically Applied ESBA105
Lead Sponsor:
ESBATech AG
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 adminis...
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, E...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00820014
Start Date
January 1 2009
End Date
September 1 2010
Last Update
September 24 2010
Active Locations (2)
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1
Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland
Lucerne, Canton of Lucerne, Switzerland, 6000
2
Pallas Gruppe
Olten, Canton of Solothurn, Switzerland, 4600