Ocular Biodistribution Study for Topically Applied ESBA105 (NCT00820014) | Clinical Trial Compass
CompletedPhase 1/2
Ocular Biodistribution Study for Topically Applied ESBA105
Switzerland79 participantsStarted 2009-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …
What they're measuring
1
Determination of intraocular ESBA105 levels, local biodistribution (aqueous and vitreous humor) and intraocular pharmacokinetics upon topical administration.
Timeframe: Collection of respective biological matrices at occasion of ocular surgery