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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06124677
Other study ID # VAB1SHOT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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