Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00823173
Other study ID # ESBA105CRD04
Secondary ID
Status Completed
Phase Phase 2
First received January 14, 2009
Last updated May 25, 2011
Start date January 2009
Est. completion date December 2010

Study information

Verified date September 2010
Source ESBATech AG
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-InstitutGermany: Ethics Commission
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Germany Charité Humboldt University Berlin
Germany Uveitis-Zentrum Franziskus Hospital Münster Nordrhein-Westfalen
Germany Universitäts-Augenklinik Tübingen Baden-Würtemberg

Sponsors (1)

Lead Sponsor Collaborator
ESBATech AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in the level of intraocular inflammation (anterior chamber cell count according to SUN Working group criteria) 28 Days No
Secondary Nature and incidence of adverse events, physical and ophthalmological findings and laboratory test results 28 Days Yes
Secondary Systemic exposure to study drug 28 Days Yes
Secondary Changes in disease severity as assessed by visual analogue scale (VAS) 28 Days No
See also
  Status Clinical Trial Phase
Completed NCT00476593 - Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications N/A
Recruiting NCT01486693 - Clinical Outcomes of Topical Ganciclovir Treatment in Cytomegalovirus Anterior Uveitis N/A
Recruiting NCT01156285 - Acute Anterior Uveitis: Psychic Burden and Pain N/A
Terminated NCT00333996 - A Study of the Safety and Efficacy of a New Treatment for Non-Infectious Anterior Uveitis Phase 2/Phase 3
Completed NCT00405496 - Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis Phase 2
Completed NCT02764697 - Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients Phase 4
Completed NCT01376362 - Topical Interferon Gamma for Macular Edema Secondary to Uveitis Phase 1/Phase 2
Recruiting NCT00407316 - Quality of Life and Visual Function in Uveitis Patients Phase 0
Completed NCT02725177 - Ocular Sarcoidosis Open Label Trial of ACTHAR Gel N/A
Completed NCT01647529 - Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis N/A
Completed NCT02517619 - Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis Phase 3
Completed NCT01505088 - Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis Phase 3
Completed NCT02879084 - Variations in Retinal Nerve Fiber Layer Thickness During Uncomplicated Anterior and Intermediate Uveitis
Completed NCT02765308 - Aqueous Humor Dynamics and Hypertensive Uveitis N/A
Completed NCT01154010 - PEMF: an Adjunct Therapy for Anterior Uveitis N/A
Completed NCT00130637 - Human Anti-Tac (Daclizumab) to Treat Juvenile Idiopathic Arthritis (JIA)-Associated Uveitis Phase 2
Completed NCT00406887 - Study of Difluprednate Ophthalmic Emulsion in the Treatment of Uveitis Phase 3
Completed NCT00876434 - Subconjunctival Sirolimus for the Treatment of Autoimmune Active Anterior Uveiti Phase 1