Exploratory Study on Topical ESBA105 in Acute Anterior Uveitis

NCT ID: NCT00823173

Last Updated: 2011-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-12-31

Brief Summary

The purpose of this study is to determine whether ESBA105, a topically applied TNF-alpha inhibitor, is safe and clinically active when applied to the eye of patients suffering from acute anterior uveitis

Detailed Description

Acute anterior uveitis (AAU) is a common, recurrent disease characterized by inflammation of the iris and ciliary body. Though usually effectively treated by topical corticosteroids, novel treatment modalities are required to overcome the limitations and adverse effect problems associated with the use of corticosteroids. TNF-alpha has been recognized as a central disease mediator in AAU, as shown by preclinical models and clinical data with systemically applied TNF-alpha inhibitors.

ESBA105 is a topically applied TNF-alpha inhibitor that is characterized by efficient penetration into the eye resulting in high intraocular drug levels. A recently completed Phase I trial confirmed that safety and tolerability of topical ESBA105 in healthy individuals is excellent and systemic exposure is low.

In this pilot trial, the safety, local tolerability and clinical activity of topical ESBA105 in the treatment of patients with acute anterior uveitis shall be explored.

Conditions

Anterior Uveitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Topical ESBA105

ESBA105 applied as eye drops

Group Type: EXPERIMENTAL

ESBA105

Intervention Type: BIOLOGICAL

ESBA105 eye drops (10mg/mL), initially applied in hourly dosing intervals, followed by later dose tapering (prolongation of dosing intervals)

Interventions

ESBA105

ESBA105 eye drops (10mg/mL), initially applied in hourly dosing intervals, followed by later dose tapering (prolongation of dosing intervals)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Signed and dated informed consent.
• Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
• 2+ anterior chamber cells according to the SUN Working Group criteria, as assessed by slit lamp biomicroscopy.
• Start of the typical first symptoms of the current attack, defined as the point in time when the patient felt the first sensation of the attack, within the last 72 hours before initiation of treatment with the study medication.
• Negative pregnancy test for females of childbearing potential (pre menopausal, <2 years post-menopausal, not surgically sterile).
• Patients with a negative QuantiFERON TB Gold test result.
• Patients who currently have no clinically apparent symptoms of an HLA B27 associated acute extraocular disorder requiring systemic immunosuppressive therapy.
• Patients who are willing and able to cooperate with study requirements.

Exclusion Criteria

• IOP elevation requiring therapy.
• Uncontrolled diabetes mellitus and diabetic retinopathy.
• Patients with a single eye or a pinhole Snellen visual acuity 20/200 or worse in the non study eye.
• Patients with 1+ or less anterior chamber cells.
• Patients with 3+ or 4+ anterior chamber cells or hypopyon.
• Patients in whom the time of the beginning of the current attack can not be determined.
• Patients exhibiting corneal ulceration or a history of recurrent herpetic keratitis or clinical evidence of herpetic dermatitis.
• Patients currently treated with topical corticosteroids.
• Patients treated with systemic immunosuppressive therapy within the last 2 months.
• Patients treated with a systemically administered TNF-alpha inhibitor within the last 2 months.
• Pregnant or breast-feeding women or women of childbearing potential, who with their partners refuse to use 2 reliable methods of contraception (including 1 barrier method) during the study.
• Male patients with a female partner who could become pregnant and who refuse, with their partner, to use 2 reliable methods of contraception (including 1 barrier method) during the study.
• Patients whose clinical presentation is suggestive for an active bacterial, viral or fungal infection anywhere in the body.
• Patients with history of recurrent infections, or a clinical presentation suggestive of a chronic infection requiring antimicrobial therapy (e.g. syphilis) including active episodes of serious viral infections by, e.g. herpes simplex, herpes zoster, cytomegalic or hepatitis viruses or clinical signs of fungal infections, such as histoplasmosis, aspergillosis or coccidiomycosis.
• Patients presenting with higher intraocular pressure in the uveitic eye than in the contralateral eye.
• Patients with known carrier status of human immunodeficiency virus, hepatitis B or hepatitis C.
• Patients with a history of demyelinating disease (multiple sclerosis) or optic neuritis.
• Patients with positive or unclear QuantiFERON TB Gold test result or history of high risk exposure to Mycobacterium tuberculosis.
• Patients with known coexisting malignancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ESBATech AG

INDUSTRY

Sponsor Role: lead

Responsible Party

ESBATech AG

Principal Investigators

Manfred Zierhut, MD

Role: STUDY_CHAIR

Universitäts-Augenklinik Tübingen

Locations

Universitäts-Augenklinik

Tübingen, Baden-Würtemberg, Germany

Uveitis-Zentrum Franziskus Hospital

Münster, North Rhine-Westphalia, Germany

Charité Humboldt University

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

ESBA105CRD04

Identifier Type: -

Identifier Source: org_study_id