Language: BG BG
← Back to results
Active (not recruiting) Phase 3 NCT06176352

A Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Choroidal Neovascularization Secondary to Pathologic Myopia

Phase 3 – large-scale trial before approval
Conditions: Choroidal Neovascularization Secondary to Pathologic Myopia

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
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).
Who can participate
Inclusion Criteria: 1. Treatment-naïve choroidal neovascularization (CNV) secondary to myopia 2. Diagnosis of active myopic CNV in the study eye: 1. Presence of high myopia, worse than -6 diopters of spherical equivalence 2. Antero-posterior elongation measurement greater than or equal to 26.0 mm 3. Presence of posterior changes compatible with pathologic myopia (e.g., tessellated fundus, lacquer cracks, etc.) 4. Presence of active leakage from CNV on FFA (determined by Central Reading Centre \[CRC\]) 5. Presence of intraretinal or subretinal fluid or increase of CST on OCT (determined by CRC) 3. 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 4. Overtly healthy as determined by medical evaluation that includes medical history, physical examination, and laboratory tests 5. Ability to comply with the study protocol, in the Investigator's judgment 6. Other protocol-defined inclusion criteria apply Exclusion Criteria: 1. Any major illness or major surgical procedure within 1 month before screening 2. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final study treatment administration 3. Uncontrolled blood pressure (systolic \>180 millimetres of mercury \[mmHg\], diastolic \>100 mmHg) 4. Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1 5. History of systemic or ocular disease that would contraindicate treatment with the investigational drug or comparator 6. Uncontrolled glaucoma in study eye 7. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities, including, but not restricted to, intravitreal, periocular or laser interventions in study eye 8. 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 9. Other protocol-defined exclusion criteria apply
Locations 11
Australia (1)
Strathfield Retina Clinic
Strathfield , New South Wales
China (1)
Beijing Hospital of Ministry of Health
Beijing
France (1)
Chi De Creteil
Créteil
Germany (1)
Universitatsklinikum Koln
Cologne
Hong Kong (1)
The University of Hong Kong
Hong Kong
Italy (1)
Ospedale Clinicizzato SS Annunziata
Chieti , Abruzzo
Poland (1)
Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.
?ód?
Singapore (1)
National University Hospital
Singapore
South Korea (1)
Yeungnam University Medical Center
Daegu
Spain (1)
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat , Barcelona
Taiwan (1)
Far Eastern Memorial Hospital
New Taipei City
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
06.03.2024
Completion date
29.05.2026
Registry ID
NCT06176352
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.