Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments

Anatomical and Visual Outcomes Following a Single Injection of Intravitreal Faricimab in Patients With Neovascular Age-related Macular Degeneration and Persisting Fluid Despite Frequent Aflibercept Treatments

The goal of this retrospective single-center chat review is to establish the efficacy and safety of a single dose of intravitreal faricimab (Vabysmo®) injection in patients with neovascular age-related macular degeneration (AMD), who were previously treated with aflibercept (Eylea®) and had persisting intraretinal or subretinal fluid despite frequent treatments.

Study Overview

• Status: Completed
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Drug: Faricimab

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Miklos Schneider

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with neovascular age-related macular degeneration (AMD)

Description

Inclusion criteria

• Presence of neovascular age-related macular degeneration (AMD) in the study eye
• >50 years of age
• Previous intravitreal anti-VEGF treatment with aflibercept (Eylea®) or with aflibercept and ranibizumab (Lucentis®) in the study eye
• Minimum of 6 monthly aflibercept injections
• Persisting intraretinal or subretinal fluid or both, despite at least 3 consecutive monthly aflibercept injections in the study eye before switching to faricimab

Exclusion criteria

• Neovascular conditions other than AMD (e.g., choroidal neovascularisation due to other causes) or co-existence of other retinal disease in the study eye
• Significant optical media opacities that would result in poor imaging quality on OCT scans in the study eye
• Intraocular surgery in the study eye 3 months before or within 1 month after the treatment switch

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients; Patients who received intravitreal faricimab injections between May and September, in 2023. and conform the inclusion/exclusion criteria.

Drug: Faricimab; The Injections were performed according to local standard protocol, that included the use of 2-3 drops of topical tetracaine anesthesia, use of eye speculum, topical 5% povidone-iodine disinfection, a 30G-needle, injection site 3.5 mm posterior from the limbus marked by calipers in supertemporal or inferotemporal quadrants, a sterile cotton tip tamponade at the site of injection after removal of the needle, and no post-procedure antibiotics.; Other Names: Vabysmo (6 mg, 0.05 ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients responding to the treatment switch	Defined as reduction or disappearance of the intra- or subretinal fluid at 4 weeks following a single injection of faricimab	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Durability of a single injection in cases of favorable treatment response without residual fluid	Time of reappearance of the fluid	Up to 16 weeks
Differences in patient characteristics between individuals responding and not responding to faricimab		4 weeks
Changes in visual acuity after the treatment switch		4 weeks
Changes in central retinal thickness after the treatment switch	Measured on optical coherence tomography (OCT) scans	4 weeks
Changes in pigment epithelium detachment (PED) height after the treatment switch	Measured on optical coherence tomography (OCT) scans	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of ocular and systemic adverse events	As safety endpoint	4 weeks

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Principal Investigator: Miklos Schneider, MD, PhD, Rigshospitalet Glostrup

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): November 15, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: November 1, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 9, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 3, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Faricimab
• Other Study ID Numbers: VAB1SHOT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No