Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
10
SUBRETINAL HYPERREFLECTIVE MATERIAL
To determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16
Key facts
- Sponsor
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 26 Feb 2026 → ongoing
- Decision date (initial)
- 2025-12-15
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To determine the percentage of patients with resolution of subretinal hyperreflective material (SHRM) at week 16
Secondary objectives 13
- To determine the percentage of patients with resolution of SHRM at weeks 4, 12, 20, 24 and 48
- To determine the percentage of patients with conversion of type 2 MNV to type 1 MNV and mixed (type 1 and 2) to type 1
- To determine the percentage of fibrosis, fibrin, subretinal hemorrhage and fibrovascular tissue
- To measure the maximum diameter and height of SHRM
- To assess the change in lesion size (area) (related to fibrovascular tissue)
- To record the presence or absence of intraretinal fluid and subretinal fluid
- To record the presence of hyper-reflective dots in the inner (1 mm) and outer (3 mm) layers
- To assess whether there is a change in quality of life after administration of Faricimab
- To determine the durability of the drug in the patient
- To determine whether a gain in visual acuity (BCVA) occurs
- To record retinal sensitivity
- To determine the change in central macular thickness
- To evaluate safety
Conditions and MedDRA coding
SUBRETINAL HYPERREFLECTIVE MATERIAL
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 9
- 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 that could compromise the best corrected visual acuity and interfere in the values of retinal parameters
- Any ocular or neurological condition (including cognitive impairment) 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
- Men and 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Resolution of SHRM at week 16
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Vabysmo 120 mg/mL solution for injection in pre-filled syringe
PRD11908357 · Product
- Active substance
- Faricimab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVITREAL USE
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 6 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01LA09 — -
- Marketing authorisation
- EU/1/22/1683/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Sponsor organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Address
- Cruces Plaza 12
- City
- Barakaldo
- Postcode
- 48903
- Country
- Spain
Scientific contact point
- Organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Contact name
- uiceecc regulatoria
Public contact point
- Organisation
- Asociacion Instituto De Investigacion Sanitaria Biobizkaia
- Contact name
- uiceecc regulatoria
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Roche Farma S.A. ORG-100003548
|
Getafe, Spain | Other |
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 100 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Consorcio Hospital General Universitario De Valencia
OFTALMOLOGIA, Avenida Tres Cruces 2, 46014, Valencia
Hospital Universitario Puerta De Hierro De Majadahonda
OFTALMOLOGIA, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Hospital Universitario Basurto
OFTALMOLOGIA, Montevideo Etorbidea 16-18, 48013, Bilbao
Metavision Arruzafa S.L.
OFTALMOLOGIA, Avenida De La Arruzafa 9, 14012, Cordoba
Hospital Clinico Universitario De Valladolid
OFTALMOLOGIA, Avenida Ramon Y Cajal 3, 47003, Valladolid
Oftalmologia Vistahermosa S.L.
OFTALMOLOGIA, Avenida De La Ilustracion 1, Poligono Industrial De Burjassot, Burjassot
Centro De Oftalmologia Barraquer S.A.
OFTALMOLOGIA, Calle Muntaner 314, 08021, Barcelona
Hospital Clinico San Carlos
OFTALMOLOGIA, Calle Del Profesor Martin Lagos Sn, 28040, Madrid
Hospital General Universitario De Albacete
OFTALMOLOGIA, Calle Hermanos Falco 37, 02006, Albacete
Instituto Oftalmologico Fernandez-Vega S.L.
OFTALMOLOGIA, Principado De Asturias, Avenida Doctores Fernandez Vega 34, Oviedo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2026-02-26 | 2026-06-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522701-38-00 | 1 |
| Protocol (for publication) | FARIDUO_PROTOCOLO_V2_1_02032026 | 2.1 |
| Protocol (for publication) | FARIDUO_PROTOCOLO_V2_1_02032026_CC | 2.1 |
| Protocol (for publication) | FARIDUO_PROTOCOLO_V2_12112025 | 2 |
| Protocol (for publication) | FARIDUO_PROTOCOLO_V3_0_16032026 | 3 |
| Protocol (for publication) | FARIDUO_PROTOCOLO_V3_0_16032026_CC | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangment | 1 |
| Subject information and informed consent form (for publication) | FARIDUO_HIP_CI_V3_25112025 | 3 |
| Subject information and informed consent form (for publication) | FARIDUO_HIP_CI_V3_25112025_CC | 3 |
| Subject information and informed consent form (for publication) | FARIDUO_HIP_CI_V4_0_16032026 | 4 |
| Subject information and informed consent form (for publication) | FARIDUO_HIP_CI_V4_0_16032026_CC | 4 |
| Subject information and informed consent form (for publication) | L1_SIS AND ICF adults_V1_20250828 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Faricimab_CAS | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-522701-38-00 | 1 |
| Synopsis of the protocol (for publication) | Synopsis of protocol_ES | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-15 | Spain | Acceptable 2025-12-12
|
2025-12-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-03 | Spain | Acceptable 2025-12-12
|
2026-03-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-24 | Spain | Acceptable 2026-05-11
|
2026-05-14 |