Vabysmo 6 MG in 0.05 ML Injection: The study drug, Faricimab (Vabysmo®), will be administered at a dose of 6 mg/0.05 ml, by intravitreal injection, following the indications in the product's technical data sheet.
Whose aim is to:
Determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16.
This study is intended to be performed in the ophthalmology departments or ophthalmology clinics of the participating sites, located in Spain.
Macular degeneration is an eye disease characterised by progressive damage to the macula leading to a loss of central vision. There are two types of macular degeneration, dry and wet or exudative. The prevalence of the latter in Spain is 1.9% in people aged 65 and over. Among the subtypes of macular neovascularisation (MNV), type 2 is rare (9%), with the majority being mixed type 1 and 2 cases (13.5%). SHRM is present in about 77% of eyes with neovascular age-related macular degeneration (AMD).
Different anti-VEGF (vascular endothelial growth factor) drugs have been used for the treatment of type 2 and mixed 1 and 2 types of MNV. Following treatment, a reduction in SHRM has been observed, although results between studies vary between 34% and 56%. Improvements in best-corrected visual acuity are also achieved in eyes with type 2 MNV with anti-VEGF therapy.
| Facility | City | Region | Status |
|---|---|---|---|
| Hospital Arruzafa | Córdoba | Andalusia | Recruiting |
| Hospital Universitario Basurto | Bilbao | Bizkaia | Recruiting |
| Hospital Clínico Universitario de Valladolid | Valladolid | Castille and León | Recruiting |
| Hospital Universitario Nuestra Señora del Perpétuo Socorro | Albacete | Castille-La Mancha | Recruiting |
| Clinica Barraquer | Barcelona | Catalonia | Recruiting |
| Hospital Clínico San Carlos | Madrid | Madrid | Recruiting |
| Hospital Puerta de Hierro Majadahonda | Majadahonda | Madrid | Recruiting |
| Instituto Oftalmologico Fernandez-Vega | Oviedo | Principality of Asturias | Recruiting |
| Oftalvist Valencia | Burjassot | Valencia | Recruiting |
| Hospital General Universitario Valencia | Valencia | Valencia | Recruiting |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07403825 on ClinicalTrials.gov ↗ ← All trials in Spain