NCT07403825

Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material

Efficacy of Faricimab in Patients With Subretinal Hyperreflective Material Associated With Type 2 or Mixed Neovascular Membranes Assessed by Multimodal Imaging

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Biobizkaia Health Research Institute · Other Government
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this phase IV, multicentre, prospective, longitudinal, uncontrolled, prospective clinical trial, patients will be administered the marketed drug Vabysmo®, whose active ingredient is Faricimab. It is an injectable humanised antibody that acts on two different pathways, by neutralising both Ang-2 and VEGF-A. It is indicated for the treatment of adult patients with neovascular AMD, patients with visual impairment due to diabetic macular oedema or patients with visual impairment due to macular oedema secondary to retinal vein occlusion. It may also have a role in stabilising neovascular membranes, as well as a possible antifibrotic effect, reducing the presence of SHRM, after seeing real clinical cases with subretinal haemorrhage and very good response to this drug, probably due to its dual inhibition with Ang-2 suppression.

Conditions

• Macular Degeneration, Age Related

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2026-02-11
• Last updated: 2026-02-17