Neovascular Age-related Macular Degeneration (nAMD)
Conditions
Brief summary
This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.
Interventions
DRUGFaricimab
Participants will receive 6-mg faricimab intravitreal (IVT) injections in the study eye according to the dosing regimen for the study arm to which they are randomized.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Overtly healthy as determined by medical evaluation that includes medical history and physical examination * Agreement to adhere to the contraception requirements described in the protocol Ocular Inclusion Criteria for Study Eye: * Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT) * BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study \[ETDRS\] protocol and addressed at the initial testing distance of 4 meters on Day 1) * Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis
Exclusion criteria
Ocular
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52 | Baseline and average of Weeks 44, 48, and 52 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100 | Baseline and average of Weeks 92, 96, and 100 |
| Change from Baseline in BCVA Score Over Time | From Baseline to Week 100 |
| Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time | From Baseline to Week 100 |
| Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time | From Baseline to Week 100 |
| Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time | From Baseline to Week 100 |
| Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52 | Baseline and average of Weeks 44, 48, and 52 |
| Change from Baseline in CST Averaged Over Weeks 92, 96, and 100 | Baseline and average of Weeks 92, 96, and 100 |
| Change from Baseline in CST Over Time | From Baseline to Week 100 |
| Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100 | Weeks 52 and 100 |
| Incidence and Severity of Ocular Adverse Events | From first study treatment to Week 100 |
| Incidence and Severity of Non-Ocular Adverse Events | From first study treatment to Week 100 |
Countries
Australia, Canada, China, France, Germany, Italy, Singapore, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed