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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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