Health Condition 1: null- Uveitis
Conditions
Interventions
Intervention1: AIN457: AIN457 300mg s.c every 2 weeks
Intervention2: AIN457: AIN457 300mg s.c. every 4 weeks
Intervention3: AIN457: AIN457 150mg s.c every 4 weeks
Control Intervention1: Placebo: Place
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male and female subjects greater than or equal to 18 years of age. Where relevant, parents will also sign the informed consent according to local laws and regulations. 2. Patients with diagnosis of chronic non infectious intermediate uveitis, posterior uveitis or panuveitis in at least one eye 3. Evidence of active intermediate, posterior or panuveitis (grade greater than or equal to 2+ vitreous haze with or without the presence of anterior chamber cells) at screening and baseline in at least one eye 4. Requirement for any of the following immunosuppressive therapies for the treatment or prevention of uveitis • Prednisone or equivalent greater than or equal to 10 mg daily at any time within the past 3 months • Greater than or equal to 1 periocular injection or greater than or equal to 1 intravitreal corticosteroid injection (i.e. triamcinolone) in the study eye within the past 6 months (the last injection must not have been given 6 weeks prior to screening) • Treatment with either cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate at any time within the past 3 months. (Patients treated with chlorambucil or cyclophosphamide within the past 5 years are ineligible for the study) • Patients not meeting the above specified criteria for immunosuppressive therapies are eligible for enrollment if they are intolerant to systemic immunosuppressive therapy as determined by the study investigator 5. Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed, and dated informed consent before any study assessment is performed
Exclusion criteria
Exclusion criteria: Ocular concomitant conditions or disease 1. Patients receiving or that may require prednisone (or equivalent) greater than or equal to 1.5 mg/kg/day for the treatment of their active uveitis. 2.Patients with a primary diagnosis of Behçets disease, anterior uveitis, or any intermediate uveitis, posterior uveitis or panuveitis in which the manifestation(s) of the active intraocular inflammatory disease may spontaneously resolve or that are not characterized by the presence of either anterior chamber cells or vitritis (vitreous cell and haze) such as the white dot retino-choroidopathies (e.g. punctuate inner choroidopathy (PIC), acute zonal occult outer retinopathy (AZOOR) 3. Patients with infectious uveitis or uveitis of an underlying diagnosis that is uncertain and would reasonably include a disease for which immunosuppression would be contraindicated (e.g. ocular lymphoma). Ocular treatments 4. Treatment with intravitreal antiVEGF agents administered to the study eye within 3 months prior to screening. 5. Treatment with fluocinolone acetonide implant (Retisert®) in the study eye within the last 3 years, or dexamethasone intravitreal implant and any other investigational corticosteroid implants in the study eye within the last 6 months. 6. Intraocular surgery or laser photocoagulation in the study eye within the last 6 weeks prior to screening except for a diagnostic vitreous or aqueous tap with a small-gauge needle. 7. Planned elective ocular surgery during the study. 8. Ocular disease that would interfere with ocular evaluations (e.g. corneal scarring, cataract, vitreous hemorrhage) or that in the opinion of the investigator would complicate the evaluation of the safety or efficacy of the study treatment (e.g. uncontrolled glaucoma, toxoplasma scar, macular scarring). 9. Current use of or likely need for systemic medications known to be toxic to the lens, retina, or optic nerve (e.g., deferoxamine, chloroquine, ethambutol, etc.) Systemic conditions or treatments 10. Any previous treatment with AIN457 11. Any systemic biologic therapy (e.g. interferon, infliximab, daclizumab, etanercept, or adalimumab) given intravenously or subcutaneously within 3 months prior to screening. No biologic therapy other than the investigational study treatment will be allowed during the course of the clinical trial. 12. Any prior treatment with systemic alkylating agents (cyclophosphamide, chlorambucil) within the past 5 years prior to screening. 13. Treatment with any live or live attenuated vaccine (including vaccine for varicella-zoster or measles) within 2 months prior to screening. No treatment with live or live attenuated vaccines will be allowed during the course of the clinical trial. 14. Active systemic infections during the last two weeks prior to screening (exception. common cold) 15. Underlying metabolic, hematologic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at an unacceptable risk for participation in an immunomodulatory therapy. 16. Systemic or extraocular disease that would contraindicate long-term immunosuppression, especial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in vitreous haze grade in the study eye from baseline to 28 weeks or at time of rescue, if earlier.Timepoint: baseline to 28 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| ? Change from baseline in Quality of Life/Patient reported outcome assessmentsTimepoint: baseline to 28 weeks;? change in immunosuppressive medication score from baseline to Week 28Timepoint: baseline to 28 weeks;? Mean change in best corrected visual acuity from baseline to 28 weeksTimepoint: baseline to 28 weeks;? Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 28 weeksTimepoint: baseline to 28 weeks;? Proportion of responders with no recurrence of active intermediate, posterior, or panuveitis in the study eye at 28 weeksTimepoint: baseline to 28 weeks | — |
Countries
India
Contacts
Public ContactMurugananthan K
Outcome results
None listed