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Активно (без набиране) Фаза 3 NCT06176352

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

Фаза 3 – широко изпитване преди одобрение
Заболявания: Choroidal Neovascularization Secondary to Pathologic Myopia

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
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).
Кой може да участва
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
Места на провеждане 11
Австралия (1)
Strathfield Retina Clinic
Strathfield , New South Wales
Китай (1)
Beijing Hospital of Ministry of Health
Beijing
Франция (1)
Chi De Creteil
Créteil
Германия (1)
Universitatsklinikum Koln
Cologne
Hong Kong (1)
The University of Hong Kong
Hong Kong
Италия (1)
Ospedale Clinicizzato SS Annunziata
Chieti , Abruzzo
Полша (1)
Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.
?ód?
Сингапур (1)
National University Hospital
Singapore
Южна Корея (1)
Yeungnam University Medical Center
Daegu
Испания (1)
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat , Barcelona
Taiwan (1)
Far Eastern Memorial Hospital
New Taipei City
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
06.03.2024
Крайна дата
29.05.2026
Регистрационен номер
NCT06176352
Източник
anzctr
Запитване за медицински туризъм

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