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Clinical Trials in China / NCT06795048
Active, not recruiting Phase 4

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

NCT06795048 · tracked via the Priya Life Science China tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 4
Started
2025-03-14
Last updated
2026-07-31

Condition(s) studied

Neovascular Age-related Macular Degeneration (nAMD)

Investigational drug(s) / intervention(s)

Faricimab

Faricimab: Participants will receive 6-mg faricimab intravitreal (IVT) injections in the study eye according to the dosing regimen for the study arm to which they are randomized.

Study summary

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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (67)

FacilityCityRegionStatus
Orange County Retina Medical Group Santa Ana California
Florida Retina Institute Orlando Florida
Ctr for Retina & Macular Dis Winter Haven Florida
Retinal Vitreal Consultants Chicago Illinois
University Retina and Macula Associates, PC Lemont Illinois
New England Retina Consultants Springfield Massachusetts
Sierra Eye Associates Sparks Nevada
Retina Associates of New Jersey Teaneck New Jersey
Vision Research Center at Eye Associates of New Mexico Albuquerque New Mexico
Charles Retina Institute Germantown Tennessee
Retina Consultants of Texas Schertz Texas
Strathfield Retina Clinic Strathfield New South Wales
Sydney Eye Hospital Sydney New South Wales
Adelaide Eye and Retina Centre Adelaide South Australia
Centre For Eye Research Australia East Melbourne Victoria
Retina Specialists Victoria Rowville Victoria
The Lions Eye Institute Nedlands Western Australia
St. Joseph's Health Care London Ontario
Retina Institute of Ottawa Ottawa Ontario
Toronto Retina Institute Toronto Ontario
Toronto Western Hospital Toronto Ontario
Hopital du Saint Sacrement Québec Quebec
Peking University People's Hospital Beijing China
West China Hospital of Sichuan University Chengdu China
Sichuan Provincial People's Hospital Chengdu China
Zhongshan Ophthalmic Center, Sun Yat-sen University Guangzhou China
Eye and ENT hospital, Fudan University Shanghai China
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech Wuhan China
Centre Retine Gallien Bordeaux France
Hopital Edouard Herriot - CHU Lyon Lyon France
Centre Ophtalmologique de L'Odeon Paris France
Hopital Lariboisiere Paris France
Centres Ophtalmologique St Exupéry Saint-Cyr-sur-Loire France
Clinique de l'Union Saint-Jean France
Augenzentrum Prof. Koch GmbH Frankfurt Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde Hanover Germany
Augenzentrum am St Franziskus-Hospital Münster Germany
Universitatsklinikum Ulm, Augenklinik und Poliklinik Ulm Germany
Universitätsklinikum Würzburg, Augenklinik und Poliklinik Würzburg Germany
Azienda ospedaliero universitaria Policlinico Riuniti di Foggia;SC Oculistica Foggia Apulia

+ 27 more sites — see the full list on the official registry below.

More Hoffmann-La Roche trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06795048 on ClinicalTrials.gov ↗ ← All trials in China