Mycophenolate sodium (Myfortic) in the Treatment of Uveitis: a Pilot Study.
- Conditions
- inflammatory eye diseaseuveitis1002187710027665
- Registration Number
- NL-OMON30290
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
patients with steroid refractory non-infectious uveitis
1. fundus not visualizable opacities.
2. requiring ocular surgery < 3 months of treatment, or surgery in the prior 3 months.
3. pregnancy , 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
19. Lues infection or serology
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Therapeutic equality between Myfortic® and cyclosporine:<br /><br>§ Decrease of inflammatory response.<br /><br>§ Improvement of BVCA</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints<br /><br>§ Cystoid macular edema.<br /><br>§ A possible relation with Inflammatory markers with therapeutic efficacy<br /><br>§ Adverse effects.<br /><br>§ Total amount of steroids.<br /><br>§ Time to relapse</p><br>