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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06124677
• Other study ID #: VAB1SHOT
• Status: Completed
• Start date: November 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 1, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

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.

Locations

Country	Name	City	State
Denmark	Miklos Schneider	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Frequency of ocular and systemic adverse events	As safety endpoint	4 weeks
Primary	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	Durability of a single injection in cases of favorable treatment response without residual fluid	Time of reappearance of the fluid	Up to 16 weeks
Secondary	Differences in patient characteristics between individuals responding and not responding to faricimab		4 weeks
Secondary	Changes in visual acuity after the treatment switch		4 weeks
Secondary	Changes in central retinal thickness after the treatment switch	Measured on optical coherence tomography (OCT) scans	4 weeks
Secondary	Changes in pigment epithelium detachment (PED) height after the treatment switch	Measured on optical coherence tomography (OCT) scans	4 weeks