Uveitis.
Conditions
Interventions
Treament with registered medication:
3 months of 1 mg/kg/d prednisone in tapering schedule + ciclosporine twice daily total 5mg/kg/d compared with same amount of prednisone + 720mg mycophenolaat sodi
Sponsors
JAM van Laar, ErasmusMC
Eligibility
Inclusion criteria
Inclusion criteria: 1. Eligible patients with uveitis not responding to steroids due to: a. Ocular sarcoidosis; b. Intermediate uveitis; c. Behçet’s syndrome; d. Idiopathic Retinal Vasculitis; e. Birdshot; f. Vogt-Koyanagi-Harada disease; g. Sympathetic ophthalmia; h. Idiopathic panuveitis; 2. No systemic immunomodulatory agents other than steroids; 3. Significant flare requiring intensification of therapy (prednisone); 4. Visual acuity of 0.1 or better in at least one eye; 5. Adequate birth control measures; 6. The screening laboratory: ● Hemoglobin ≥ 6.5 mmol/L; ● WBC ≥ 3.0 x 109/L; ● Neutrophils ≥ 1.5 x 109/L; ● Platelets ≥ 100 x 109/L; ● SGOT and AF 20 ml/min; 7. Normal chest X-ray < 3 months; 8. Ability to adhere to the study visit schedule andprotocol requirements; 9. Capability of giving informed consent.
Exclusion criteria
Exclusion criteria: 1. Inability to visualize the fundus; 2. Ocular surgery < 3 months of treatment; 3. Women who are pregnant, nursing, or planning pregnancy < 6 months; 4. Investigational drugs < 1 month or < 5 x T½; 5. Systemic immunosuppressive therapy, other than steroids for ocular disease; 6. Creatinine clearance of < 20ml/min; 7. Hypersensitivity to prednisone, cyclosporine, or Myfortic®; 8. Clinically significant infection; 9. Documented HIV infection; 10. Patients with active TB or evidence of latent TB; 11. Positive Lues serology and or significant Lues infection; 12. Oportunistic infections < 6 months; 13. Current signs or symptoms of severe organic disease; 14. Transplanted organ (except corneal transplant); 15. Malignancy < 5 years (except squamous or basal cell carcinoma of the skin); 16. Lymphoproliferative disease; 17. Substance abuse (drugs or alcohol); 18. Poor tolerability of venipuncture or lack of adequate venous access; 19. Recent live vaccinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total dose of prednisone. | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatoir response (cells and haze): ● BCVA; ● Cystoid macular oedeem; ● Inflammatoire markers; ● Adverse effects; ● Tijd tot relapse. | — |
Contacts
Public ContactJ.A.M. Laar van
Erasmus University Medical Center Room D-419
Outcome results
None listed