Exploratory Study on Topical ESBA105 in Acute Anterior Uveitis

NCT00823173 | Completed Phase 2

• 1 other identifier: ESBA105CRD04
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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

Conditions

Anterior Uveitis

Keywords

Uveitis; TNF-alpha; Topical; ESBA105; scFv antibody fragment; ocular inflammation

Outcome Measures

Primary Outcomes (1)

• Changes in the level of intraocular inflammation (anterior chamber cell count according to SUN Working group criteria)

  28 Days

Secondary Outcomes (3)

• Nature and incidence of adverse events, physical and ophthalmological findings and laboratory test results

  28 Days

• Systemic exposure to study drug

  28 Days

• Changes in disease severity as assessed by visual analogue scale (VAS)

  28 Days

Study Arms (1)

Topical ESBA105

EXPERIMENTAL

ESBA105 applied as eye drops

Biological: ESBA105

Interventions

ESBA105 BIOLOGICAL

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

Topical ESBA105

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent.
• Patients with the typical presentation of HLA-B27 positive AAU (unilateral, painful anterior uveitis of sudden onset).
• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ESBATech AG: lead

Study Sites (3)

Universitäts-Augenklinik

Tübingen, Baden-Würtemberg, 72076, Germany

Location

Uveitis-Zentrum Franziskus Hospital

Münster, North Rhine-Westphalia, 48145, Germany

Location

Charité Humboldt University

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Uveitis, Anterior; Uveitis

Interventions

ESBA105

Condition Hierarchy (Ancestors)

Panuveitis; Uveal Diseases; Eye Diseases

Study Officials

• Manfred Zierhut, MD

  Universitäts-Augenklinik Tübingen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 14, 2009
• First Posted: January 15, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 26, 2011

Record last verified: 2010-09

Locations

DE (3)