H34.8
Conditions
Interventions
Group 1: intravitreal injection of faricimab (Vabysmo ®) 120 mg/ml for refractory secondary macular edema in retinal vein occlusion, as “switch therapy” in pre-treated patients
Sponsors
Universitätsklinikum Ulm, Klinik für Augenheilkunde
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with macular edema (ME) secondary to retinal vein occlusion (either central retinal vein occlusion [CRVO] or branch retinal vein occlusion [BRVO]) who showed an insufficient response to prior anti-VEGF therapy with aflibercept (2 mg), bevacizumab, or ranibizumab were included. ME was considered refractory if intraretinal fluid persisted and central subfield thickness (CST) remained = 270 µm despite receiving at least three anti-VEGF injections at intervals of no more than six weeks.
Exclusion criteria
Exclusion criteria: Exclusion criteria included any ocular disease other than RVO that could contribute to ME, ischemic maculopathy involving the fovea, disruption of the ellipsoid zone, iris or retinal neovascularization, best-corrected visual acuity (BCVA) worse than 1.3 logMAR, significant media opacities (e.g., cataract, vitreous hemorrhage), uncontrolled glaucoma, other vitreoretinal pathologies (e.g., vitreomacular traction, epiretinal membrane, or macular hole), previous vitreoretinal surgery, or any history of intravitreal steroid injection or implant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anatomical changes, defined as mean changes in central subfield thickness (CST) after therapy switch to faricimab. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Functional changes, here mean changes in best corrected visual acuity (BCVA) after switching to faricimab t defined time points. - Changes in optical coherence tomography (OCT) biomarkers such as intraretinal fluid (IRF), subretinal fluid (SRF), and hyperreflective foci (HRF) after switching to faricimab at defined time points. - Mean intended treatment extension until the next faricimab injection after switching to faricimab in the treat-and-extend (TAE) regimen. - Number of fluid-free intervals/visits. - Number of faricimab injections per year. - Number of adverse events during treatment with faricimab. | — |
Countries
Germany
Contacts
Public ContactAdnan Kilani
Universitätsklinikum Ulm, Klinik für Augenheilkunde
Outcome results
None listed