A Study to Determine Safety and Long-Term Effectiveness of Faricimab in Participants with Age-Related Macular Degeneration

Recruiting

• Conditions: Neovascular Age-Related Macular Degeneration

• Registration Number: 2024-517545-13-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

To evaluate the efficacy of intravitreal (IVT) injections of faricimab in the study eye following the regimen in each of the treatment arms as change from baseline in best corrected visual acuity (BCVA) averaged over Weeks 44, 48, and 52

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-06-02
• Last Update Posted: 2025-06-18

Recruitment & Eligibility

• Status: Authorised, recruiting
• Sex: Not specified
• Target Recruitment: 89

Inclusion Criteria

Age ≥50 years at the time of signing Informed Consent Form

Overtly healthy as determined by medical evaluation that includes medical history and physical examination.

Agreement to adhere to the contraception requirements described

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 OCT.

Ocular Inclusion Criteria for Study Eye: 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).

Ocular Inclusion Criteria for Study Eye:Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.

Exclusion Criteria

Macular neovascularization due to causes other than AMD, 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 will be excluded from study entry

Ocular Exclusion for Both Eyes Potential participants are excluded from the study if any of the following criteria apply: – 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

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters		Change from baseline in BCVA score as measured using the ETDRS VA chart at a starting distance of 4 meters

Secondary Outcome Measures

Name	Time	Method
Change from baseline in BCVA averaged over Weeks 92, 96, and 100		Change from baseline in BCVA averaged over Weeks 92, 96, and 100
Change from baseline in BCVA over time		Change from baseline in BCVA over time
Change from baseline in central subfield thickness (CST) averaged over Weeks 44, 48, and 52		Change from baseline in central subfield thickness (CST) averaged over Weeks 44, 48, and 52
Change from baseline in CST averaged over Weeks 92, 96, and 100		Change from baseline in CST averaged over Weeks 92, 96, and 100
Change from baseline in CST over time		Change from baseline in CST over time
Proportion of participants on a Q4W, Q8W, Q12W, Q16W, Q20W, and Q24W treatment interval at Weeks 52 and 100		Proportion of participants on a Q4W, Q8W, Q12W, Q16W, Q20W, and Q24W treatment interval at Weeks 52 and 100
Incidence and severity of ocular adverse events		Incidence and severity of ocular adverse events
Incidence and severity of non-ocular adverse events		Incidence and severity of non-ocular adverse events

Trial Locations

Locations (24)

Clinique De L'Union; 🇫🇷 Saint-Jean, France

Assistance Publique Hopitaux De Paris; 🇫🇷 Paris Cedex 10, France

Selarl Retine Tourny; 🇫🇷 Bordeaux, France

Societe Civile De Moyens Des Docteurs Maury-Francais-Coscas-Favard-Krivosic; 🇫🇷 Paris, France

Hospices Civils De Lyon; 🇫🇷 Lyon Cedex 03, France

Retina; 🇫🇷 Saint-Cyr-Sur-Loire, France

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico; 🇮🇹 Milan, Italy

Azienda Ospedaliero-Universitaria Sant Andre; 🇮🇹 Rome, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi; 🇮🇹 Ancona, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti; 🇮🇹 Foggia, Italy

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Clinique De L'Union

🇫🇷Saint-Jean, France

Xavier Benouaich

Site contact

+33561378734

benouaich_xavier@yahoo.fr