Diabetic Macular Edema
Conditions
Interventions
Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.
Sponsors
Clinical trials information
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Previous enrollment in and completion of Study GR40349 (YOSEMITE) or GR40398 (RHINE), without study or study drug discontinuation - Signed Informed Consent Form - Ability to comply with the study protocol, in the investigator's judgment - For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final intravitreal injection of faricimab - Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications - Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications - History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study - Requirement for continuous use of any medications or treatments indicated as prohibited therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety - Incidence and Severity of Ocular Adverse Events - Incidence and Severity of Systemic (Non-Ocular) Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy, exploratory, phamacokinetics - Change in best-corrected visual acuity (BCVA) over time as measured using the Early Treatment Diabetic Retinopathy Study chart at a starting distance of 4 meters - Change in central subfield thickness (CST) over time as measured by spectral-domain optical coherence tomography - Proportion of patients with presence of central retina intraretinal fluid, subretinal fluid, and both over time - Number of faricimab injections received during the LTE study - The proportion of patients on a every 4 weeks (Q4W), every 8 weeks, every 12 weeks, and every 16 weeks treatment interval during the study - Proportion of patients with a 2- or 3-step improvement in their Diabetic Retinopathy Severity Scale (DRSS) score over time - Presence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study from the start of the LTE study | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Peru, Poland, Portugal, Republic of Korea, Russia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, United States,
Contacts
Public ContactClinical trials information
Chugai Pharmaceutical Co., Ltd.
Outcome results
None listed