Faricimab Quarterly Maintenance for Neovascular Age Related Macular Degeneration

NCT06742307 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: CIRB-2024-169-3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

We aimed to investigate the success rate of a planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab, for nAMD to achieve stability without recurrence at a tertiary eye centre.

Conditions

Macular Degeneration Choroidal Neovascularization

Keywords

neovascular age related macular degeneration; faricimab

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  The primary outcome is the change from baseline in best-corrected visual acuity (BCVA) at week 52.

  52 weeks

Secondary Outcomes (3)

• Anatomical success

  52 weeks

• Functional success

  52 weeks

• Maintenance treatment failure

  52 weeks

Study Arms (1)

Faricimab treatment arm

ACTIVE COMPARATOR

A planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. The intervention faricimab is injected into the eyeball with a 30G needle.

Drug: Faricimab Injection [Vabysmo]

Interventions

Faricimab Injection [Vabysmo] DRUG

A planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. This intervention schedule is not specifically studied in other literature, although similar schedule exist.

Faricimab treatment arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged over 50 years, neovascular AMD with foveal involvement, both treatment-naïve and recurrent cases. There were no specific criteria for initial best-corrected visual acuity (BCVA). Only active subfoveal MNV are included, including types 1, 2, and 3.

You may not qualify if:

• eyes that received any anti-VEGF therapy in the prior six months,
• eyes with other disease entities (e.g., diabetic macula oedema, retinal vein occlusions, central serous chorioretinopathy, myopicmacular neovascularisation),
• concurrent macula laser (except photodynamic therapy) and ocular surgery (e.g., cataract surgery or vitrectomy) in the prior six months and the study period.

Sponsors & Collaborators

• Hospital Authority, Hong Kong: lead

Study Sites (1)

Department of Ophthalmology, United Chrisitian Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (4)

• Wong DHT, Li KKW. Fixed Quarterly Dosing of Aflibercept after Loading Doses in Neovascular Age-Related Macular Degeneration in Chinese Eyes. J Clin Med. 2023 Dec 27;13(1):145. doi: 10.3390/jcm13010145.

  PMID: 38202151 BACKGROUND

• Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.

  PMID: 35085502 BACKGROUND

• Wong WL, Su X, Li X, Cheung CM, Klein R, Cheng CY, Wong TY. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health. 2014 Feb;2(2):e106-16. doi: 10.1016/S2214-109X(13)70145-1. Epub 2014 Jan 3.

  PMID: 25104651 BACKGROUND

• Ambati J, Fowler BJ. Mechanisms of age-related macular degeneration. Neuron. 2012 Jul 12;75(1):26-39. doi: 10.1016/j.neuron.2012.06.018.

  PMID: 22794258 BACKGROUND

Related Links

• Genentech, Inc, Roche Group. HIGHLIGHTS OF PRESCRIBING INFORMATION.

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

faricimab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel Ho Tak Wong, FRCOphth (UK)

CONTACT

+852 3949 3411; WHT454@ha.org.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients included, once diagnosed with neovascular macular dengeration, will embark on a planned quarterly (every 12-16 weeks) faricimab injection schedule for one year, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. If disease inactivity is not achieved during the maintenance phase, patient's injection interval may be shortened.

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 19, 2024
• Study Start: August 21, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 6/2025 for 2 years till 6/2027
• Access Criteria: Other researches submitting such request to us. they will be able to access the research protocol and current enrollment status. No patient information will be shared. They can access it by sending us the request. We will seek advice from our local ethics committee CIRB for advice for entertaining such requests.

Locations

HK (1)