Neovascular age-related macular degeneration (nAMD) MedDRA version: 20.0 Level: LLT Classification code 10025410 Term: Macular degeneration (senile) of retina, unspecified System Organ Class: 100000004853
Conditions
Sponsors
F.Hoffmann La-Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Previous enrollment in and completion of Study GR40306 (TENAYA) or Study GR40844 (LUCERNE), without study or study drug discontinuation • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs. Women must remain abstinent or use contraceptive methods with a failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 1180
Exclusion criteria
Exclusion criteria: • Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days after the final dose 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-related procedure preparations, 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 |
|---|---|
| Main Objective: •To evaluate the long-term ocular and systemic safety and tolerability of faricimab administered intravitreally in patients with nAMD;Secondary Objective: NOT APPLICABLE;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: 1-2. Approximately 104 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Australia, Austria, Bulgaria, Denmark, France, Germany, Hong Kong, Hungary, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche LTD
Outcome results
None listed