Status:
ACTIVE_NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Choroidal Neovascularization Secondary to Pathologic Myopia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 (CN...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2026
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT06176352
Start Date
March 6 2024
End Date
May 29 2026
Last Update
December 26 2025
Active Locations (63)
Enter a location and click search to find clinical trials sorted by distance.
1
Strathfield Retina Clinic
Strathfield, New South Wales, Australia, 2135
2
Sydney Eye Hospital
Sydney, New South Wales, Australia, 2000
3
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, Australia, 2000
4
Centre For Eye Research Australia
East Melbourne, Victoria, Australia, 3002