Switching to Faricimab in Neovascular Age-related Macular Degeneration Resistant to Both Aflibercept and Ranibizumab

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

Short-term Results With Faricimab After Multiple Sequential Treatment Switches Due to Resistance With Both Aflibercept and Ranibizumab in Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06231121
• Other study ID #: MULTISW-VAB1SHOT
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: January 19, 2024

Study information

• Verified date: January 2024
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this retrospective single-center chart review is to establish the response rate, efficacy and safety of a single dose of intravitreal faricimab injection in real-world patients with aflibercept- and ranibizumab-resistant neovascular age-related macular degeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 19, 2024
• Est. primary completion date: January 15, 2024
• 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
• Previous treatment with minimum 6 consecutive, monthly aflibercept (Eylea®) injections in the study eye without optimal treatment response, defined as persisting intraretinal fluid or subretinal fluid or both on optical coherence tomography scans
• Subsequently, a sequential switch to ranibizumab (Lucentis®), with minimum 1 injection, also without optimal response
• Finally, a sequential treatment switch from ranibizumab 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	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	Differences in patient characteristics between individuals responding and not responding to faricimab		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
Secondary	Changes in best-corrected visual acuity after the treatment switch		4 weeks