A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
- Eye Disorder
- Choroidal neovascularization
- Myopia
Recruiting
- Australia
- China
- France
- Germany
- Hong Kong
- Italy
- Poland
- Singapore
- South Korea
- Spain
- Taiwan
NCT06176352 2023-506707-25-00 CR44829
Trial Summary
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).
A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
Eligibility Criteria
- Treatment-naïve choroidal neovascularization (CNV) secondary to myopia
- Diagnosis of active myopic CNV in the study eye:
- Presence of high myopia, worse than -6 diopters of spherical equivalence
- Antero-posterior elongation measurement greater than or equal to 26.0 mm
- Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.)
- Presence of active leakage from CNV on FFA (determined by Central Reading Centre [CRC])
- Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC)
- BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol on Day 1
- Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests
- Ability to comply with the study protocol, in the Investigator's judgment
- Other protocol-defined inclusion criteria apply
- Any major illness or major surgical procedure within 1 month before screening
- Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration
- Uncontrolled blood pressure (systolic >180 millimetres of mercury [mmHg], diastolic >100 mmHg)
- Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
- History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator
- Uncontrolled glaucoma in study eye
- Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye
- Prior or concomitant periocular or intravitreal pharmacological treatment, including anti-VEGF medication, for other retinal diseases (e.g. geography atrophy, nAMD, DME etc.) in study eye
- Other protocol-defined exclusion criteria apply
For the latest version of this information please go to www.forpatients.roche.com