Neovascular Age-related Macular Degeneration
Conditions
Brief 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.
Interventions
DRUGFaricimab
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.
Sponsors
Rigshospitalet, Denmark
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Differences in patient characteristics between individuals responding and not responding to faricimab | 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 |
| Changes in best-corrected visual acuity after the treatment switch | 4 weeks | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of ocular and systemic adverse events | 4 weeks | Safety endpoint |
Countries
Denmark
Outcome results
None listed