This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled study evaluating the efficacy and safety of faricimab in patients with myopic choroidal neovascularization (CNV). This non-inferiority study will compare 6.0 mg faricimab versus 0.5 mg ranibizumab administered at a pro-re-nata (PRN) dosing regimen after an initial active IVT treatment administration at randomization (Day 1).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
280
Faricimab 6 mg intravitreal (IVT) injection on Day 1 with Q4W PRN treatment thereafter to Week 44. At Week 48, participants will attend a follow-up visit.
Ranibizumab 0.5 mg intravitreal (IVT) injection on Day 1 with Q4W PRN treatment thereafter to Week 44. At Week 48, participants will attend a follow-up visit.
The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Participants will undergo the sham procedure at study visits where no study drug is to be administered, in order to maintain masking.
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Weeks 4, 8, and 12
Time frame: Baseline and Average of Weeks 4, 8, and 12
Change from Baseline in BCVA Over Time
Time frame: From Baseline through Week 48
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Averaged Over Weeks 4, 8, and 12
Time frame: Baseline and Average of Weeks 4, 8, and 12
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline Over Time
Time frame: From Baseline through Week 48
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time
Time frame: From Baseline through Week 48
Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline or Achieving a BCVA of ≥84 Letters Over Time
Time frame: From Baseline through Week 48
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time
Time frame: From Baseline through Week 48
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time
Time frame: From Baseline through Week 48
Percentage of Participants Only Receiving One Injection From Baseline to Weeks 12, 24, and 48
Time frame: From Baseline to Weeks 12, 24, and 48
Number of Intravitreal Injections Received From Baseline to Weeks 12, 24, and 48
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Strathfield Retina Clinic
Strathfield, New South Wales, Australia
Sydney Eye Hospital
Sydney, New South Wales, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, Australia
Beijing Hospital of Ministry of Health
Beijing, China
Beijing Tong Ren Hospital, Capital Medical University
Beijing, China
Peking Union Medical College Hospital
Beijing, China
Beijing Tsinghua Changgung Hospital
Beijing, China
The Second Hospital of Jilin University
Changchun, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
...and 53 more locations
Time frame: From Baseline to Weeks 12, 24, and 48
Change from Baseline in Central Subfield Thickness (CST) of the Study Eye Averaged Over Weeks 4, 8, and 12
Time frame: Baseline and Average of Weeks 4, 8, and 12
Change from Baseline in CST of the Study Eye Over Time
Time frame: From Baseline through Week 48
Change from Baseline in Total Area of the Choroidal Neovascularization Lesion at Weeks 12 and 48
Time frame: Baseline, Weeks 12 and 48
Change from Baseline in Total Area of the Choroidal Neovascularization Leakage at Weeks 12 and 48
Time frame: Baseline, Weeks 12 and 48
Percentage of Participants with Absence of Macular Leakage at Weeks 12 and 48
Time frame: Weeks 12 and 48
Incidence and Severity of Ocular Adverse Events
Time frame: From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
Incidence and Severity of Non-Ocular Adverse Events
Time frame: From first dose until 35 days after the last dose of study treatment (up to 48 weeks)
Prevalence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
Time frame: At Baseline and from first dose until end of study (up to 48 weeks)