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Age-Related Macular Degeneration (ARMD) Clinical Trials

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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• People aged 50 and over.

• Diagnosed with bilateral or unilateral AMD.

• Eyes with SHRM and type 2 or mixed (type 1 and 2) neovascular membrane.

• Näive eyes treated with Faricimab following SmPC (summary of product characteristic).

• They agree to participate in the study and sign the informed consent form.

Locations
Other Locations
Spain
Hospital Universitario Nuestra Señora del Perpétuo Socorro
RECRUITING
Albacete
Clinica Barraquer
RECRUITING
Barcelona
Hospital Universitario Basurto
RECRUITING
Bilbao
Oftalvist Valencia
RECRUITING
Burjassot
Hospital Arruzafa
RECRUITING
Córdoba
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Instituto Oftalmologico Fernandez-Vega
RECRUITING
Oviedo
Hospital General Universitario Valencia
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Time Frame
Start Date: 2026-05-25
Estimated Completion Date: 2028-10
Participants
Target number of participants: 100
Treatments
Experimental: Vabysmo
Experimental arm
Related Therapeutic Areas
Geographic Atrophy
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: Biobizkaia Health Research Institute
Collaborators: Roche Farma, S.A

This content was sourced from clinicaltrials.gov

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