Health Condition 1: H579- Unspecified disorder of eye and adnexa
Conditions
Interventions
Intervention1: IL-6 Monoclonal Antibody-RO7200220: IL-6 Monoclonal Antibody
Solution for IVT Injection
20 mg/mL and 5 mg/mL, depending on the dose
Dosage level - Arm A: 1 mg, Arm B: 0.25 mg
No dose in
Sponsors
F HoffmannLa Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosis of non infectious uveitis (NIU) of any anatomical type (anterior, intermediate, posterior, panuveitis) 2. Active and inactive NIU is allowed. 3. Macular edema due to NIU defined as CST more than equal to 325 um on Spectralis SD-OCT or more than equal 315 um on Topcon or Cirrus at screening evaluated by CRC 4. BCVA letter score of 73 to 19 letters (both inclusive) on ETDRS-like charts (20 OR 40 to 20 OR 400 Snellen equivalent) at Day 1
Exclusion criteria
Exclusion criteria: 1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study 2. Evidence of active or latent syphilis infection 3. Evidence of active or latent tuberculosis infection, or previous or current HIV diagnosis 4. Serious acute or chronic medical illness 5. Blood transfusion within 12 months prior to screening 6. Any major non-ocular surgical procedure within 1 month prior to Day 1 7.Any febrile illness within 1 week prior to Day 1 8. Any known hypersensitivity to fluorescein, dilating eye drops, or topical anesthetic eye drops
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with 15 letter improvement from baseline in BCVA at Week 16Timepoint: From baseline to Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of participants with 15 letter improvement from baseline in BCVA at Week 20 (8 weeks after the final study drug dose) 2.Change from baseline in CST (central subfield thickness)at Week 16. Timepoint: 1. From Baseline to week 20 2. From Baseline to week 16;Other Secondary Outcomes 1.Change from baseline in BCVA and CST at Weeks 20 and 52 Number and type of rescue treatments received and time taken. 2. Number of PRN injections received and time to 1st PRN injection 3. Change from baseline in the NEI VFQ-25 composite score at Weeks 16 and 52 4.Incidence and severity of adverse events and AESIs 5.Percent change from baseline in corneal endothelial cell (CEC) density at Week 24 & 52 Timepoint: Week 16, Week 24 and Week 52 (as applicable);PK/ PD Outcome 1. AH concentration 2. Serum concentration, 3. IL-6 suppression in AHTimepoint: During the study conduct, as applicable | — |
Countries
Argentina, Australia, Czech Republic, France, Germany, India, Japan, Singapore, Spain, Switzerland, Turkey, United States of America
Contacts
Public ContactManjula Ujagiri
Roche Products (India) Pvt. Ltd.
Outcome results
None listed