Acute, unilateral anterior uveitis MedDRA version: 9.1 Level: LLT Classification code 10002709 Term: Anterior uveitis
Conditions
Interventions
Product Name: ESBA105
Product Code: ESBA105 10 mg/ml
Pharmaceutical Form: Eye drops, solution
Current Sponsor code: ESBA105 10 mg/ml
Other descriptive name: humanised single-chain (scFv) antibody frag
Sponsors
ESBATech, an Alcon Biomedical Research Unit LLC
Eligibility
Sex/Gender
All
Inclusion 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 Standardization of Uveitis Nomenclature (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. - Male or female of any race and =18 years. - Negative pregnancy test for women of childbearing potential (pre-menopausal, =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: If any of the following criteria are met, the patient will not be eligible to participate in the study: - Glaucoma. - IOP elevation requiring therapy. - Uncontrolled diabetes mellitus and/or 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 known as HLA-B27 negative, based on results of previous HLA antigen testing or with any other known cause for their anterior uveitis other than HLA-B27-associated AAU. - Patients in which the time of the beginning of the current attack can not be determined. - Patients exhibiting corneal ulceration or a history of recurrent herpetic keratinitis or clinical evidence of herpetic dermatitis. - Patients currently treated with topical corticosteroids. - Patients treated with stable doses >10 mg daily systemic prednisone (or comparable corticosteroids) within the last 2 months. - 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. (Primary forms of contraception include intrauterine devices, oral contraceptive agents that the patient has already been using for at least 90 days before screening, and injectable/implantable/insertable hormonal birth control products. Secondary forms of contraception include diaphragms, latex condoms, and cervical caps.) - 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. In particular, patients have to be excluded if they present with granulomaous precipitates or plaque-like lesions on the corneal endothelium interpreted by the investigator as indicative for infectious origin of the uveitis attack. - 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. - Patients with congestive heart failure New York Heart Association Grade III or IV. - Patients with uncontrolled hypertension (=160/100 millimetres of mercury [mmHg]). - Patients with significant haematological disease (total white cell count below 2 x 109/litre [L]). - Patients who participated in a clinical study with investigational medicinal products (IMPs) within 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - Evaluation of safety and local tolerability of topical ESBA105 (first data in disease population). - Evaluation of systemic exposure to ESBA105 following topical application to the eye (first data in disease population). - Exploratory evaluation of clinical activity of topical ESBA105 in inflammatory ocular disease (human leukocyte antigen [HLA]-B27 positive acute anterior uveitis [AAU]). ;Secondary Objective: ;Primary end point(s): There are exploratory endpoints only. Safety and Tolerability: - The nature and incidence of adverse events (AEs), changes in vital signs, electrocardiogram (ECG), physical and ophthalmological examination findings and laboratory test results. Systemic Exposure: - Systemic exposure to topical ESBA105 will be monitored at each visit by analysis of ESBA105 levels in the patient’s serum. Clinical Activity: - Changes in the level of ocular inflammation observed at each visit in the treatment period with study medication. According to the SUN Working Group criteria, “improved activity” is defined as reduction of anterior chamber cells by two levels. | — |
Countries
Austria, Germany
Outcome results
None listed