NCT07403825

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

Recruiting now Phase 4 Last updated 25 May 2026

What this trial tests

Phase 4 trial testing Vabysmo 6 MG in 0.05 ML Injection in Macular Degeneration, Age Related in 100 participants. Currently enrolling.

Timeline

25 May 2026

Primary endpoint
1 October 2028

1 October 2028

Quick facts

Lead sponsor	Biobizkaia Health Research Institute
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	25 May 2026
Primary completion	1 October 2028
Estimated completion	1 October 2028
Sites	10 locations across Spain

Drugs / interventions tested

• Vabysmo 6 MG in 0.05 ML Injection — full drug profile →

Conditions studied

• Macular Degeneration, Age Related — all drugs for Macular Degeneration, Age Related →

Sponsor

Biobizkaia Health Research Institute

Who can join

50 and older, any sex, with Macular Degeneration, Age Related. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• to assess the resolution of subretinal hyperreflective material (SHRM) at week 16
  Time frame: finish to the clinical trial
  The percentage of patients with resolution of SHRM at week 16.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.