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A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
Eye Disorder Choroidal neovascularization Myopia
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Trial Identifier
NCT06176352, CR44829, 2023-506707-25-00
Condition
Choroidal Neovascularization Secondary to Pathologic Myopia
Official Title
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
Study 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).
Eligibility Criteria
All
≥18 Years
No
Inclusion 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
Exclusion Criteria
- 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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com