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Ocular Biodistribution Study for Topically Applied ESBA105

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00820014
Recruitment Status : Completed
First Posted : January 9, 2009
Last Update Posted : September 24, 2010
Information provided by:

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 administration to the eye.

Condition or disease Intervention/treatment Phase
Cataract Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Evaluation of Tolerability, Safety and Ocular Pharmacokinetics of Topically Applied ESBA105 in Patients Undergoing Cataract Surgery or Combined Cataract Surgery and Vitrectomy
Study Start Date : January 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: 1
ESBA105 eye drops
Drug: Placebo
Placebo control (vehicle) eye drops applied 4-times a day for 4 days before ocular surgery

Placebo Comparator: 2
Placebo control (vehicle)
Drug: Placebo
Placebo control (vehicle) eye drops applied 4-times a day for 4 days before ocular surgery

Primary Outcome Measures :
  1. Determination of intraocular ESBA105 levels, local biodistribution (aqueous and vitreous humor) and intraocular pharmacokinetics upon topical administration. [ Time Frame: Collection of respective biological matrices at occasion of ocular surgery ]

Secondary Outcome Measures :
  1. Exploratory assessment of the anti-inflammatory potential of prophylactic, topical ESBA105 for prevention of post-surgical inflammation following cataract surgery. [ Time Frame: 10 Days following ocular surgery ]
  2. Assessment of local tolerability and safety of topical ESBA105. [ Time Frame: up to 10 Days following ocular surgery ]
  3. Assessment of systemic exposure upon topical application of ESBA105. [ Time Frame: 1 Day following ocular surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00820014

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Pallas Gruppe
Olten, Solothurn, Switzerland, 4600
Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland
Luzern, Switzerland, 6000
Sponsors and Collaborators
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Principal Investigator: Michael A Thiel, MD, PhD Kantonsspital Luzern, Augenklinik, CH-6000 Luzern 16, Switzerland
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Responsible Party: Peter Lichtlen, Medical Director, ESBATech AG Identifier: NCT00820014    
Other Study ID Numbers: ESBA105CRD03
First Posted: January 9, 2009    Key Record Dates
Last Update Posted: September 24, 2010
Last Verified: January 2009
Keywords provided by ESBATech AG:
scFv antibody fragment
cataract surgery
Irvine-Gass syndrome
Additional relevant MeSH terms:
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Lens Diseases
Eye Diseases