A trial of LFG316 for administration in eyes affected by active but non-infectious forms of uveitis for which therapy with immunosuppressive agents is not sufficient.
- Conditions
- Active non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapyMedDRA version: 20.0 Level: LLT Classification code 10022557 Term: Intermediate uveitis System Organ Class: 100000161411MedDRA version: 20.0 Level: LLT Classification code 10033687 Term: Panuveitis System Organ Class: 100000014975MedDRA version: 20.0 Level: LLT Classification code 10036370 Term: Posterior uveitis System Organ Class: 100000015065MedDRA version: 20.0 Level: LLT Classification code 10066681 Term: Acute uveitis System Organ Class: 100000014975Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2011-003254-90-GB
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
•Male or female patients 18 years or older
•Active NIU, in at least one eye, as defined below, in patients requiring intensification of systemic immunosuppressive therapy.
-Vitreous haze at least 1+ on the scale of Nussenblatt et al 1985, or
-Chorioretinal lesions due to uveitis (chorioretinal lesions due to infections will exclude the patient)
- Patients who present with a flare and who are at the time of the enrollment on systemic corticosteroid or non-steroidal immunosuppressants will have their therapy tapered or stopped, respectively, at the time of intravitreal LFG316 administration.
- Visual acuity (ETDRS method) of 20 letters (20/400 snellen equivalent) or better in the study eye
•Female patients, must not be pregnant or lactating and must, unless post-menopausal, use effective contraception.
•Ability to provide informed consent and comply with the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Uveitis so severe that, in the investigator's judgment, it is too risky to test an experimental drug
•Bilateral uveitis for which, in the opinion of the investigator, systemic immunosuppressive therapy is required to manage the inflammation in the fellow eye; use of local therapy in the fellow eye is acceptable and not an explicit exclusion (see section 5.5.7 for acceptable concomitant treatments)
•Uncontrolled glaucoma or ocular hypertension in either eye, defined as an intraocular pressure (IOP) >30 mmHg while on medication for the specific condition
•Forms of uveitis that may spontaneously resolve such as multiple evanescent white dot syndrome (MEWDS).
•In the opinion of the investigator, clinically significant abnormality in screening laboratory results or electrocardiogram
•In the study eye, cataract that is expected to interfere with study conduct or require surgery during the study
•History of infectious uveitis or endophthalmitis in either eye
•History of retinal detachment
•Patients taking corticosteroids or other systemic immunosuppressive medication for any other disease (e.g., asthma or other autoimmune disease) where the tapering of the immunosuppressant would not be safe because of the risk of exacerbation of the extra ocular disease
•Any biologic immunosuppressive agent given via intravitreal, intravenous or subcutaneous route within 4-12 months of screening depending on the agent.
•Any intraocular surgery, intravitreal injection, periocular injection, or laser photocoagulation to the study eye within 90 days prior to dosing.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method