Macular Degeneration, Age RelatedPhase 4NCT07403825
Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material
A Phase 4 study testing Vabysmo 6 MG in 0.05 ML Injection in people with Macular Degeneration, Age Related, run by Biobizkaia Health Research Institute at 10 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Age Related
- What is being tested?
- Vabysmo 6 MG in 0.05 ML Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 10 sitesSpain
- Study dates
- 25 May 2026to Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
Spain10 sites, 10 recruiting
- Recruiting
Hospital Universitario Nuestra Señora del Perpétuo Socorro
Albacete, Castille-La Mancha, 02006
Sergio Copete, 967 59 77 99, scopete@sescam.jccm.es
- Recruiting
Clinica Barraquer
Barcelona, Catalonia, 08021
Santiago Abengoechea, 932095311, sah@barraquer.com
- Recruiting
Hospital Universitario Basurto
Bilbao, Bizkaia, 48013
Pedro Fernandez-Avellaneda, 944006000, PEDRO.FERNANDEZAVELLANEDA@osakidetza.eus
- Recruiting
Oftalvist Valencia
Burjassot, Valencia, 46100
Roberto Gallego-Pinazo, 963 51 33 04, rgallego@oftalvist.es
- Recruiting
Hospital Arruzafa
Córdoba, Andalusia, 14012
Juan Manuel Cubero, 957340118, JMCUBERO@HOSPITALARRUZAFA.COM
- Recruiting
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Jose Ignacio Fernandez Vigo, 91 330 3000, joseignacio.fernandez-vigo@salud.madrid.org
- Recruiting
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Jorge Ruiz Medrano, 911 91 60 00, jrmedrano@salud.madrid.org
- Recruiting
Instituto Oftalmologico Fernandez-Vega
Oviedo, Principality of Asturias, 33012
Alvaro Fernandez-Vega, 985 24 01 41, afvg@fernandez-vega.com
- Recruiting
Hospital General Universitario Valencia
Valencia, Valencia, 46014
Javier Montero, 963 13 18 00, montero_javher@gva.es
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, 47003
Salvatore Di Lauro, 983 420 003, sdi@saludcastillayleon.es
About this study
Official title: Efficacy of Faricimab in Patients With Subretinal Hyperreflective Material Associated With Type 2 or Mixed Neovascular Membranes Assessed by Multimodal Imaging
Whose aim is to:
Determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16.
Read more
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.
Read the detailed description
In this phase IV, multicentre, prospective, longitudinal, uncontrolled, prospective clinical trial, patients will be administered the marketed drug Vabysmo®, whose active ingredient is Faricimab. It is an injectable humanised antibody that acts on two different pathways, by neutralising both Ang-2 and VEGF-A. It is indicated for the treatment of adult patients with neovascular AMD, patients with visual impairment due to diabetic macular oedema or patients with visual impairment due to macular oedema secondary to retinal vein occlusion. It may also have a role in stabilising neovascular membranes, as well as a possible antifibrotic effect, reducing the presence of SHRM, after seeing real clinical cases with subretinal haemorrhage and very good response to this drug, probably due to its dual inhibition with Ang-2 suppression.
- Conditions
- Macular Degeneration, Age Related
- Being tested
- Vabysmo 6 MG in 0.05 ML Injection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vabysmo 6 MG in 0.05 ML InjectionDrug
Also called Faricimab
The study drug, Faricimab (Vabysmo®), will be administered at a dose of 6 mg/0.05 ml, by intravitreal injection, following the indications in the product's technical data sheet.
| Study group | Role | What they receive |
|---|---|---|
| Vabysmo | Experimental | Experimental arm Receives: Drug: Vabysmo 6 MG in 0.05 ML Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
to assess the resolution of subretinal hyperreflective material (SHRM) at week 16
The percentage of patients with resolution of SHRM at week 16.
Measured: finish to the clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start25 May 2026
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration, Age RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biobizkaia Health Research Institute
- Sponsor type
- Other government
- Collaborators
- Roche Farma, S.A
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403825
- Sponsor's protocol ID
- FARIDUO
- Status last verified
- May 2026
- First submitted
- 4 Feb 2026
- Last updated
- 28 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Faricimab in Patients With Subretinal Hyperreflective Material Associated With Type 2 or Mixed Neovascular Membranes Assessed by Multimodal Imaging
- ClinicalTrials.gov ID
- NCT07403825
- Acronym / sponsor ID
- FARIDUO
- Conditions
- Macular Degeneration, Age Related
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Biobizkaia Health Research InstituteOther government
- Collaborators
- Roche Farma, S.A
- Study start
- 25 May 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this phase IV, multicentre, prospective, longitudinal, uncontrolled, prospective clinical trial, patients will be administered the marketed drug Vabysmo®, whose active ingredient is Faricimab. It is an injectable humanised antibody that acts on two different pathways, by neutralising both Ang-2 and VEGF-A. It is indicated for the treatment of adult patients with neovascular AMD, patients with visual impairment due to diabetic macular oedema or patients with visual impairment due to macular oedema secondary to retinal vein occlusion. It may also have a role in stabilising neovascular membranes, as well as a possible antifibrotic effect, reducing the presence of SHRM, after seeing real clinical cases with subretinal haemorrhage and very good response to this drug, probably due to its dual inhibition with Ang-2 suppression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vabysmo | Experimental | Drug: Vabysmo 6 MG in 0.05 ML InjectionExperimental arm |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vabysmo 6 MG in 0.05 ML InjectionAlso: FaricimabThe study drug, Faricimab (Vabysmo®), will be administered at a dose of 6 mg/0.05 ml, by intravitreal injection, following the indications in the product's technical data sheet. | Drug | Vabysmo |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vabysmo 6 MG in 0.05 ML Injection in people with Macular Degeneration, Age Related, run by Biobizkaia Health Research Institute at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to assess the resolution of subretinal hyperreflective material (SHRM) at week 16 (time frame: finish to the clinical trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.