NCT07403825RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 4 Feb 2026
- Start date
- 25 May 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Biobizkaia Health Research Institute
- Diseases
- Macular degeneration
- NCT number
- NCT07403825
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 25 May 2026 to the primary completion date, Oct 2028
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women\* of childbearing potential who are unable or unwilling to use highly effective methods of contraception (bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices) from the start to the end of the study.
- Woman of childbearing potential: considered as such if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), or has not undergone surgical sterilization (removal of ovaries and/or uterus).
Other illness
- Eyes with type 2 MNV and other macular diseases (myopia, posterior uveitis, systemic diseases, such as pseudoxanthoma elasticum).
- Patients with other retinal diseases, such as central serous chorioretinopathy, diabetic retinopathy, retinal vascular occlusion, uveitis, myopic maculopathy or any other retinal disease that could compromise the best-corrected visual acuity and interfere with retinal parameters.
- Any neurological condition (including cognitive impairment, stroke, dementia, Parkinson, anxiety or schizophrenia) that, in the opinion of the investigator, would pose a risk to patient's safety or interfere with the assessment, procedures, or completion of the study.
Other
- Eyes with type 1, aneurysmal type 1 and type 3 MNV.
- Eyes with ocular media opacity.
- People who are participating or will participate in any type of clinical trial.
- Pregnant women.
- Breastfeeding women.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Nuestra Señora del Perpétuo Socorro Coordinator of this site? Confirm its status | Albacete | Spain | Recruiting |
| Clinica Barraquer Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Recruiting |
| Oftalvist Valencia Coordinator of this site? Confirm its status | Burjassot | Spain | Recruiting |
| Hospital Arruzafa Coordinator of this site? Confirm its status | Córdoba | Spain | Recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Puerta de Hierro- Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| Instituto Oftalmologico Fernandez-Vega Coordinator of this site? Confirm its status | Oviedo | Spain | Recruiting |
| Hospital General Universitario Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
| Hospital Clínico Universitario de Valladolid Coordinator of this site? Confirm its status | Valladolid | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.