Faricimab for subretinal hyper-reflective material in AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4, multicenter, prospective study will enroll adults with neovascular AMD and subretinal hyper-reflective material who have not previously been treated with Faricimab. Participants receive an injection of Faricimab 6 mg in 0.05 mL and are followed to week 16 to see if SHRM resolves. The trial is uncontrolled and conducted in ophthalmology clinics across Spain. Primary outcome is the percentage of eyes with SHRM resolution at week 16. Safety monitoring will occur throughout the study. The design seeks to explore the potential dual-action effects of Ang-2 and VEGF-A inhibition on SHRM and related retinal parameters.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Eyes with type 1, aneurysmal type 1 and type 3 MNV.
* Eyes with type 2 MNV and other macular diseases (myopia, posterior uveitis, systemic diseases, such as pseudoxanthoma elasticum).
* Eyes with ocular media opacity.
* 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.
* People who are participating or will participate in any type of clinical trial.
* Pregnant women.
* Breastfeeding women.
* 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).

Where it's running

• Hospital Arruzafa
  Córdoba, Andalusia, Spain Recruiting
• Hospital Universitario Basurto
  Bilbao, Bizkaia, Spain Recruiting
• Hospital Clínico Universitario de Valladolid
  Valladolid, Castille and León, Spain Recruiting
• Hospital Universitario Nuestra Señora del Perpétuo Socorro
  Albacete, Castille-La Mancha, Spain Recruiting
• Clinica Barraquer
  Barcelona, Catalonia, Spain Recruiting
• Hospital Clínico San Carlos
  Madrid, Madrid, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.