Single Injection of Faricimab for nAMD With Persisting Fluid Despite Frequent Aflibercept Treatments
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | 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:
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Outcome Measures
Primary Outcome Measures
- Proportion of patients responding to the treatment switch [4 weeks]
Defined as reduction or disappearance of the intra- or subretinal fluid at 4 weeks following a single injection of faricimab
Secondary Outcome Measures
- Proportion of patients with or without residual fluid [4 weeks]
In case of favorable treatment response
- Durability of a single injection in cases of favorable treatment response without residual fluid [Up to 16 weeks]
Time of reappearance of the fluid
- 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 [4 weeks]
Measured on optical coherence tomography (OCT) scans
- Changes in pigment epithelium detachment (PED) height after the treatment switch [4 weeks]
Measured on optical coherence tomography (OCT) scans
Other Outcome Measures
- Frequency of ocular and systemic adverse events [4 weeks]
As safety endpoint
Eligibility Criteria
Criteria
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
-
Persisting intraretinal or subretinal fluid or both, despite at least 6 consecutive monthly aflibercept injections in the study eye
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 within 3 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miklos Schneider | Glostrup | Denmark | 2600 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
- Principal Investigator: Miklos Schneider, MD, PhD, Rigshospitalet Glostrup
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VAB1SHOT