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

Phase 4

Recruiting

• Conditions: Neovascular Age-related Macular Degeneration (nAMD)
• Interventions: Drug: Faricimab

• Registration Number: NCT06795048
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-24
• Study First Submitted QC: 2025-01-24
• Study First Posted: 2025-01-27
• Study Start: 2025-03-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-23
• Primary Completion: 2027-02-27
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 274

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A: Faricimab Early Treat & Extend Regimen	Faricimab	-
Arm B: Faricimab Modified Treat & Extend Regimen	Faricimab	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Best-Corrected Visual Acuity (BCVA) Score Averaged Over Weeks 44, 48, and 52	Baseline and average of Weeks 44, 48, and 52

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in BCVA Score Averaged Over Weeks 92, 96, and 100	Baseline and average of Weeks 92, 96, and 100
Change from Baseline in BCVA Score Over Time	From Baseline to Week 100
Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse Over Time	From Baseline to Week 100
Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline Over Time	From Baseline to Week 100
Percentage of Participants with BCVA Snellen Equivalent of 20/40 or Better Over Time	From Baseline to Week 100
Change from Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44, 48, and 52	Baseline and average of Weeks 44, 48, and 52
Change from Baseline in CST Averaged Over Weeks 92, 96, and 100	Baseline and average of Weeks 92, 96, and 100
Change from Baseline in CST Over Time	From Baseline to Week 100
Percentage of Participants on Different Treatment Intervals at Weeks 52 and 100	Weeks 52 and 100
Incidence and Severity of Ocular Adverse Events	From first study treatment to Week 100
Incidence and Severity of Non-Ocular Adverse Events	From first study treatment to Week 100

Trial Locations

Locations (17)

Retinal Vitreal Consultants; 🇺🇸 Chicago, Illinois, United States

New England Retina Consultants; 🇺🇸 Springfield, Massachusetts, United States

Retina Consultants of Texas; 🇺🇸 Schertz, Texas, United States

Centre For Eye Research Australia; 🇦🇺 East Melbourne, Victoria, Australia

The Lions Eye Institute; 🇦🇺 Nedlands, Western Australia, Australia

Toronto Retina Institute; 🇨🇦 Toronto, Ontario, Canada

Peking University People's Hospital; 🇨🇳 Beijing, China

Yeungnam Univ. Hospital; 🇰🇷 Daegu, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

National Taiwan University Hospital; 🇨🇳 Zhongzheng Dist., Taiwan

Ctr for Retina & Macular Dis; 🇺🇸 Winter Haven, Florida, United States

University Retina and Macula Associates, PC; 🇺🇸 Lemont, Illinois, United States

Strathfield Retina Clinic; 🇦🇺 Strathfield, New South Wales, Australia

Adelaide Eye and Retina Centre; 🇦🇺 Adelaide, South Australia, Australia

Retina Specialists Victoria; 🇦🇺 Rowville, Victoria, Australia

Retina Institute of Ottawa; 🇨🇦 Ottawa, Ontario, Canada

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan