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Tests treatment safety and results for Macular Degeneration, Age Related
Official title Efficacy of Faricimab in Patients With Subretinal Hyper-reflective Material
ClinicalTrials.gov ID: NCT07403825
What this study is testing
What is Vabysmo 6 MG in 0.05 ML Injection?
Vabysmo 6 MG in 0.05 ML Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for macular degeneration, age related.
Also referred to as Faricimab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Any neurological condition (including cognitive impairment, stroke, dementia, Parkinson, anxiety or schizophrenia) that, in the opinion of the...
- People who are participating or will participate in any type of clinical trial.
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Córdoba, Andalusia, Spain
- Bilbao, Bizkaia, Spain
- Valladolid, Castille and León, Spain
- Albacete, Castille-La Mancha, Spain
- Barcelona, Catalonia, Spain
- Madrid, Madrid, Spain
- Majadahonda, Madrid, Spain
- Oviedo, Principality of Asturias, Spain
- Burjassot, Valencia, Spain
- Valencia, Valencia, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Córdoba, Andalusia, Spain; Bilbao, Bizkaia, Spain; Valladolid, Castille and León, Spain; Albacete, Castille-La Mancha, Spain; Barcelona, Catalonia, Spain; Madrid, Madrid, Spain and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.