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Active (not recruiting) Phase 4 NCT06795048

A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

Phase 4 – monitoring after market approval
Conditions: Neovascular Age-related Macular Degeneration (nAMD)

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
Overview
This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.
Who can participate
Inclusion Criteria: * Overtly healthy as determined by medical evaluation that includes medical history and physical examination * Agreement to adhere to the contraception requirements described in the protocol Ocular Inclusion Criteria for Study Eye: * Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT) * BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study \[ETDRS\] protocol and addressed at the initial testing distance of 4 meters on Day 1) * Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis Exclusion Criteria: Ocular Exclusion Criteria for Study Eye: * MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis * Retinal pigment epithelial tear involving the macula on Day 1 * Current vitreous hemorrhage on Day 1 * Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor \[VEGF\], or complement inhibitor medication) for other retinal diseases Ocular Exclusion Criteria for Fellow (Non-Study) Eye: * Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits Ocular Exclusion for Both Eyes: * History of idiopathic or autoimmune associated uveitis in either eye * Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1
Locations 12
Australia (1)
Strathfield Retina Clinic
Strathfield , New South Wales
Canada (1)
St. Joseph's Health Care
London , Ontario
China (1)
Peking University People's Hospital
Beijing
France (1)
Centre Retine Gallien
Bordeaux
Germany (1)
Augenzentrum Prof. Koch GmbH
Frankfurt
Italy (1)
Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica
Foggia , Apulia
Singapore (1)
Singapore Eye Research Institute
Singapore
South Korea (1)
Pusan National University Hospital
Busan
Spain (1)
Hospital General de Catalunya
Sant Cugat de Valles , Barcelona
Taiwan (1)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
United Kingdom (1)
Cardiff and Vale University Health Board
Cardiff
United States (1)
Orange County Retina Medical Group
Santa Ana , California
Technical details
Status
Active (not recruiting)
Phase
Phase 4
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
50 Years
Healthy volunteers
No
Start date
14.03.2025
Completion date
16.09.2027
Registry ID
NCT06795048
Source
anzctr
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