Health Condition 1: H350- Background retinopathy and retinalvascular changes
Conditions
Interventions
Intervention1: Faricimab (RO6867461): 6-mg faricimab injections will be given every 4 weeks for the treatment duration of 52 Weeks
Control Intervention1: Nil: Nil
Sponsors
F HoffmannLa Roche Ltd
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients who self-identify as Asian Indian residents of the Indian subcontinent. Diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association, and â?? Current regular use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide) for the treatment of diabetes and/or â?? Current regular use of oral anti-hyperglycemic agents for the treatment of diabetes Patients who are IVT treatment-naïve in the study eye. Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis. For women of childbearing potential: Agreement to remain abstinent or use acceptable contraception methods
Exclusion criteria
Exclusion criteria: Patients with diabetes mellitus (Type 1 or Type 2) that is currently medically untreated. Patients with previously untreated diabetes mellitus (Type 1 or Type 2) who started on oral or injectable anti-diabetic medication within 3 months prior to Day 1. Any known hypersensitivity to any of the components in the faricimab injection. Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used by the patient during the study. Any febrile illness within 1 week prior to Day 1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the treatment response in patients treated with intravitreal (IVT) injections of a 6-mg dose of faricimabTimepoint: To evaluate change in best corrected visual acuity outcome on baseline visit to Week 56 visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate treatment response on DR and DME severity outcomes in patients treated with faricimabTimepoint: .ETDRS Diabetic Retinopathy Severity Scale improvement assessment will be done from baseline visit to week 56 visit. . Proportion of patients with absence of intraretinal fluid (IRF) from baseline visit to week 56 visit. . Proportion of patients with absence of subretinal fluid (SRF) from baseline visit to week 56 visit. . Changes from baseline in central subfield thickness (CST) from baseline visit to week 56 visit. .BCVA assessment from baseline to week 56. | — |
Countries
India, Kenya, United States of America
Contacts
Public ContactManjula Ujagiri
Roche Products (India) Pvt. Ltd.
Outcome results
None listed