Clinical Trial

Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material

Recruiting Phase 4
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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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-05-29
notable Trial sites expanded: 0 -> 10 locations 2026-05-29
Trial Details
NCT Number NCT07403825
Lead Sponsor Biobizkaia Health Research Institute
Collaborators: Roche Farma, S.A
Conditions Macular Degeneration, Age Related
Enrollment 100 participants
Start Date 2026-05-25
Primary Completion 2028-10 (estimated)
Study Completion 2028-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-28