Diabetic Macular Edema (DME) MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Interventions
Product Code: RO6867461
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Faricimab
CAS Number: 1607793-29-2
Current Sponsor code: RO6867461
Other descriptive name: VA2, VEGF-Ang2 ophth
Sponsors
F.Hoffmann La-Roche Ltd
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 - For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 900
Exclusion criteria
Exclusion criteria: - Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months 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 - Requirement for continuous use of any medications or treatments indicated as prohibited therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the long term ocular and systemic safety and tolerability of faricimab administered intravitreally in patients with DME;Secondary Objective: NA;Primary end point(s): 1. Incidence and severity of ocular adverse events 2. Incidence and severity of systemic (non-ocular) adverse events ;Timepoint(s) of evaluation of this end point: 1 and 2. Approximately 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA | — |
Countries
Argentina, Australia, Austria, Brazil, Bulgaria, Canada, China, Czechia, Czech Republic, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Portugal, Russian Federation, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche LTD
Outcome results
None listed