A Study Testing How Well Faricimab Works in Patients with Subretinal Hyperreflective Material Associated with Neovascular Membranes in the Eye

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What is this study about?

This clinical trial is studying a condition called subretinal hyperreflective material, which is a type of abnormal tissue that can develop in the eye. This condition is associated with neovascular membranes, which are abnormal blood vessels that grow beneath the retina, the light-sensitive tissue at the back of the eye. These membranes are classified as type 2 or mixed type, meaning they involve different patterns of abnormal blood vessel growth. This condition is related to age-related macular degeneration, a disease that affects central vision and is common in older adults. The treatment being studied is Vabysmo, which contains the active substance faricimab. This medication belongs to a group of medicines called antineovascularization agents, which work to stop the growth of abnormal blood vessels in the eye. The medicine is given as an injection directly into the eye, a procedure called intravitreal injection.

The purpose of this study is to determine how many patients have complete clearing of the subretinal hyperreflective material after 16 weeks of treatment with faricimab. The study will use special imaging techniques called multimodal imaging to examine the eye and assess changes in this abnormal tissue. Multimodal imaging means using different types of eye scans and photographs to get detailed pictures of the structures inside the eye. This helps doctors see whether the treatment is working to remove the abnormal material from beneath the retina.

During the study, patients will receive faricimab injections into the affected eye according to the approved treatment schedule. The study will monitor patients over time to see if the abnormal tissue resolves and to evaluate how well the treatment works. The medication will be given to patients who have not previously received treatment for this condition, meaning their eyes are treatment-naive. The total treatment period for each patient will last up to three years, though the main assessment of whether the abnormal tissue has cleared will happen at week 16.

1 Initial treatment phase

Upon joining the study, your eye will be treated with Vabysmo, which contains the active substance faricimab.

The medication will be administered as an injection into the eye (intravitreal injection).

The treatment will follow the standard dosing schedule as specified in the product information.

2 Treatment continuation

Your treatment will continue according to the dosing schedule determined by the study protocol.

Each injection will deliver 120 mg/mL of the medication directly into your eye.

The injections will be repeated at intervals as determined by your treatment plan.

3 Assessment at week 16

At week 16 of the study, your eye will be evaluated using specialized imaging techniques.

The evaluation will assess whether the subretinal hyperreflective material (abnormal deposits beneath the retina) has resolved.

This assessment represents the main measurement point of the study.

4 Ongoing monitoring

Your participation in the study will continue beyond week 16.

Regular monitoring will be conducted using multiple imaging methods to track changes in your eye condition.

The study is expected to continue until September 2028.

Who Can Join the Study?

  • You must be 50 years of age or older
  • You must have been diagnosed with AMD, which is age-related macular degeneration (a condition affecting the central part of the retina at the back of the eye), in one or both eyes
  • Your eye must show SHRM, which is subretinal hyperreflective material (abnormal deposits under the retina visible on eye scans), and have a type 2 or mixed neovascular membrane (abnormal blood vessels growing under the retina)
  • Your eye must not have been previously treated for this condition, meaning you are receiving Faricimab (a medication injected into the eye) for the first time according to standard treatment guidelines
  • You must agree to take part in the study and sign an informed consent form, which is a document confirming you understand the study and agree to participate

Who Cannot Join the Study?

  • No specific exclusion criteria have been provided for this clinical trial in the available information.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hospital Clinico San Carlos Madrid Spain

Other Sites

Site Name City Country Status
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Hospital Universitario Basurto Bilbao Spain
Hospital Clinico Universitario De Valladolid Valladolid Spain
Hospital General Universitario De Albacete Albacete Spain
Oftalmologia Vistahermosa S.L. Burjassot Spain
Centro De Oftalmologia Barraquer S.A. Barcelona Spain
Instituto Oftalmologico Fernandez-Vega S.L. Oviedo Spain
Hospital General Universitario De Valencia Valencia Spain
Metavision Arruzafa S.L. Cordoba Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Recruiting
01.04.2026

Trial locations

Investigated drugs:

Faricimab is a medication that is injected into the eye to treat abnormal blood vessel growth in the retina. It works by blocking certain proteins that cause fluid buildup and damage to the back of the eye. In this study, it is being tested to see if it can help reduce abnormal material that builds up under the retina in patients with specific types of eye conditions that affect vision.

Investigated diseases:

Subretinal Hyperreflective Material – This is an abnormal finding in the eye where bright, reflective material accumulates beneath the retina, the light-sensitive layer at the back of the eye. This material can be detected during special imaging tests of the eye and appears as bright spots or areas on these scans. The condition is associated with various eye diseases that affect the retina and can interfere with normal vision. When this material builds up, it may cause changes in how well a person can see. The presence of subretinal hyperreflective material indicates ongoing activity or damage in the retinal layers. Over time, if left unaddressed, this accumulation may lead to further changes in the retinal structure.

Trial ID:
2025-522701-38-00
Protocol code:
FARIDUO
Trial Phase:
Therapeutic confirmatory (Phase III)

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