Status:
COMPLETED
Sirolimus as Therapeutic Approach to Uveitis
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
MacuSight, Inc.
Conditions:
Uveitis
Intermediate Uveitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out about the safety and effectiveness of the study drug, sirolimus, in patients with uveitis and to utilize the potential effectiveness of sirolimus, and yet to a...
Detailed Description
Uveitis is a condition in which certain parts of your eye become inflamed. The inflammation is usually recurrent. If the inflammation is not treated adequately, permanent damage to the eye and to the ...
Eligibility Criteria
Inclusion
- Males and females greater than or equal to 18 years of age;
- Able to give informed consent and attend all study visits;
- Have diagnosis of uveitis determined by the Investigator to be non infectious;
- Have active uveitis, defined as having at least 1+ Vitreous Haze and/or at least 1+ Vitreous Cell Count (SUN scale), and:
- are receiving no other treatment; or,
- are receiving prednisone ≥10 mg/day (or equivalent dose of another corticosteroid) and/or at least 1 other systemic immunosuppressant; or, b. Have inactive disease, defined as having 0.5+ Vitreous Haze or less and a grade of 0.5+ Vitreous Cell Count or less (SUN scale), and:
- are receiving prednisone \<10 mg/day (or equivalent dose of another corticosteroid) and/or at least 1 other systemic immunosuppressant.
- Have posterior, intermediate, or panuveitis; for panuveitis, if an anterior component is present, it must be less than the posterior component;
- Sufficient inflammation to require systemic treatment and, based on the Investigator's decision, warrants intravitreal or subconjunctival treatment;
- Best-corrected (ETDRS) visual acuity of 20/40 to 20/400 (approximately 70 to 20 letters) in the study eye;
- Best- corrected ETDRS visual acuity of 20/400 or better in the fellow eye (approximately 20 letters).
Exclusion
- 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 the uveitis, and the uveitis in the fellow eyes, in the opinion of the investigator, cannot be controlled with standard local therapies alone;
- Any significant ocular disease that could compromise vision in the study eye. These include, but are not limited to:
- Diabetic retinopathy: proliferative diabetic retinopathy (PDR) or non-proliferative diabetic retinopathy (NPDR) that compromise the vision.
- Age-related macular degeneration;
- Myopic degeneration with active subfoveal choroidal neovascularization.
- Any of the following treatments within 90 days prior to Day 0 or anticipated use of any of the following treatments to the study eye:
- Intravitreal injections (including but not limited to steroids or anti-vascular endothelial growth factors);
- Posterior subtenon's steroids.
- Intraocular surgery within 90 days prior to Day 0 in the study eye;
- Capsulotomy within 30 days prior to Day 0 in the study eye;
- If the patient has had glaucoma surgery (trabeculectomy or aqueous shunt device), there must be adequate conjunctiva
- History of vitreoretinal surgery or scleral buckling
- Any ocular surgery (including cataract extraction or capsulotomy) of the study eye anticipated within the first 180 days following Day 0;
- Intraocular pressure ≥25 mmHg in the study eye (glaucoma patients maintained on no more than 2 topical medications with intraocular pressure (IOP) \<25 mmHg are allowed to participate);
- Pupillary dilation inadequate for quality stereoscopic fundus photography in the study eye;
- Media opacity that would limit clinical visualization;
- Presence of any form of ocular malignancy in the study eye, including choroidal melanoma;
- History of herpetic infection in the study eye or adnexa;
- Presence of known active or inactive toxoplasmosis in either eye;
- Ocular or periocular infection in either eye;
- Participation in other investigational drug or device clinical trials within 30 days prior to Day 0, or planning to participate in other investigational drug or device clinical trials within 180 days following Day 0. This includes both ocular and non-ocular clinical trials.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00908466
Start Date
July 1 2009
End Date
February 1 2013
Last Update
August 20 2018
Active Locations (1)
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1
Wilmer Eye Institute at Johns Hopkins University
Baltimore, Maryland, United States, 21287