Mycophenolate sodium (Myfortic®) in the Treatment of Uveitis: a Pilot Study. - Mycophenolate sodium (Myfortic®) in the Treatment of Uveitis: a Pilot Study.
- Conditions
- veitisMedDRA version: 8.1Level: LLTClassification code 10046851Term: Uveitis
- Registration Number
- EUCTR2006-004709-24-NL
- Lead Sponsor
- ErasmusMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.Men or women = 18 years of age with non-infectious bilateral sight-threatening uveitis due to one of the inflammatory conditions listed below:
a.Ocular sarcoidosis: a granulomatous uveitis with posterior inflammation in a patient in which sarcoidosis has been established by means of a biopsy, cytology, or a positive scan. A diagnosis of ocular sarcoidosis can also be established on the basis of a positive ACE/ lysozyme with evidence of anergy on more than one antigen challenge.
b.Intermediate uveitis: patients with clinical features as defined by the IUSG23. However, it is important that the patient has no evidence of a systemic infection such as Lyme Borreliosis and that there is no history of neurological symptoms likely to be associated with multiple sclerosis. All patients with intermediate uveitis should have a negative MRI with gadolinium contrast, prior to being enrolled.
c.Behçet’s syndrome: the international study group classification will be used to define these patients.
d.Idiopathic Retinal Vasculitis where systemic or infectious causes have been eliminated. In particular patients will not have evidence of Wegener’s granulomatosis, SLE, PAN, polymyositis, dermatomyositis or other systemic vasculitic disorders. Patients must also lack evidence for a systemic infection, and have been adequately screened. For the purpose of this study, Eale’s disease will be excluded from the idiopathic retinal vasculitis group. However, both nonocclusive and occlusive types of retinal vasculitis can be included in the study.
e.Birdshot: the presence at some point of typical retinochoroidal cream colored lesions associated with retinal/ choroidal vasculitis, a vitritis, and a positive HLA-A29.
f.Vogt-Koyanagi-Harada disease (VKH) as defined according to the international Workgroup definition of VKH24.
g.Sympathetic ophthalmia; a granulomatous uveitis involving the choroid and retina, characterized by multiple white-yellow lesions often in the periphery, which can coalesce particularly in the circumpapillary region. It is associated with trauma or multiple prior surgeries.
2.Patients must not have been taking or still on systemic immunomodulatory agents (cyclosporine, mycophenolate, tacrolimus, sirolimus, interferon), anti-metabolites, anti-TNF-a therapy or any combination of these for the treatment of their intraocular inflammatory disease.
3.Disease that is 24 months or less in duration, or a patient with a significant flare in the past 24 months requiring intensification of anti-inflammatory therapy. A significant flare is defined as a drop of 2 lines of vision on an ETDRS chart or equivalent, or increase in vitreous flare by 2 grades.
4.Visual acuity of 0.1 or better in at least one eye.
5.Men and women of childbearing potential must use adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicidal cream, or surgical sterilization) for the duration of the study and should continue such precautions for 6 weeks after receiving the last administration.
6.The screening laboratory test results must meet the following criteria:
§Hemoglobin = 6.5 mmol/L
§WBC = 3.0 x 109/L
§Neutrophils = 1.5 x 109/L
§Platelets = 100 x 109/L
§SGOT (AST) and alkaline phosphatase levels must be within 3 times the upper limit of normal range for the laboratory conducting the test.
§Creatinine clearance > 20 ml/min
7.Must have a normal chest radiograph within 3 months prior to firs
Patients will be excluded from this study for any of the following reasons:
1.Inability to visualize the fundus due to corneal or lenticular opacities.
2.Patients requiring ocular surgery within the initial 3 months of treatment, or who have had surgery in the prior 3 months.
3.Women who are pregnant, nursing, or planning pregnancy within 6 months after screening (i.e., approximately 6 weeks following last treatment).
4.Use of any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
5.History of systemic immunosuppressive therapy, other than steroids for ocular disease.
6.Creatinine clearance of < 20ml/min.
7.Patients with known hypersensitivity to prednisone, cyclosporine, Myfortic® or to drugs with similar chemical structures.
8.Patients with any clinically significant infection.
9.Documented HIV infection.
10.Patients with active TB or evidence of latent TB.
11.Patients with opportunistic infections, including but not limited to evidence of active cytomegalovirus, active Pneumocystis carinii, Aspergillosis, Histoplasmosis or atypical mycobacterium infection, etc, within the previous 6 months.
12.Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
13.Presence of a transplanted organ (with the exception of a corneal transplant 3 months prior to screening).
14.Malignancy within the past 5 years (except for treated squamous or basal cell carcinoma of the skin without evidence of recurrence).
15.History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
16.Known recent substance abuse (drugs or alcohol).
17.Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
18.Recent live vaccinations
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assessment of therapeutic equality between Myfortic® and cyclosporine by ophthalmologic examinations including:<br>§Inflammatory response (cells and haze in anterior chamber/vitreous)21<br>§BCVA.<br>;Secondary Objective: Secondary endpoints <br>§Cystoid macular edema<br>§Inflammatory markers22<br>§Adverse effects<br>§Total amount of steroids<br>§Time to relapse<br>;Primary end point(s): Therapeutic equality between Myfortic® and cyclosporine:<br>§Decrease of inflammatory response.<br>§Improvement of BVCA<br><br>
- Secondary Outcome Measures
Name Time Method