Intravitreal Sirolimus as Therapeutic Approach to Uveitis (NCT01280669) | Clinical Trial Compass
WithdrawnPhase 2
Intravitreal Sirolimus as Therapeutic Approach to Uveitis
Stopped: Never started due to sponsor decision
United States0Started 2022-09
Plain-language summary
The purpose of this study is to find out about the safety and effectiveness of two different doses the study drug, sirolimus, administered intravitreally in patients with uveitis. The potential effectiveness of sirolimus can be utilized to control inflammation in uveitis and yet avoid the potential complications that are usually associated with the systemic use of the drug and other immunomodulatory therapies. In this study, the investigators will administer sirolimus inside the eye (intravitreally) in one of two doses (440mcg/mcL or 880mcg/mcL). Local administration of sirolimus to the eye is not expected to have effects on the rest of the body. Therefore, it may offer a safer way than the current methods used to control the inflammation caused by non-infectious uveitis.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Males and females greater than or equal to 12 years of age.
ā. Able to give informed consent and attend all study visits.
ā. Have diagnosis of uveitis determined by the Investigator to be non-infectious based on the patient's medical history, history of present illness, ocular examination, review of systems, physical examination, and any pertinent laboratory evaluations.
ā. Meet the following criteria:
Exclusion criteria
ā. Patients with bilateral uveitis who are receiving systemic immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus, or azathioprine) other than prednisone or other corticosteroids for the treatment of uveitis and the uveitis in the fellow eye, in the opinion of the Investigator, cannot be controlled with standard local therapies alone;
ā. Any significant ocular disease that could compromise the visual outcome in the study eye.
ā. Intravitreal injections (including but not limited to anti-vascular endothelial growth factors 60 days prior to the baseline;
What they're measuring
1
Frequency of uveitic attacks as assessed by vitreous haze and cells.