BridgeMD
Tests treatment safety and results for Macular Degeneration
Official title Evaluate the Efficacy of Faricimab in Patients With Neovascular Age-related Macular Degeneration
ClinicalTrials.gov ID: NCT07367282
What this study is testing
What is Faricimab Injection [Vabysmo]?
Faricimab Injection [Vabysmo] is an investigational medicine, given as a monthly injectable medicine, being studied as a potential treatment for macular degeneration.
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
- If the subject who has nAMD voluntarily agrees to participate in this clinical study by signing the informed consent form, screening assessments will be conducted within 4 weeks prior to the first dose of the investigational drug. During the screening visit, the eligibility of the subject will be assessed and one study eye will be selected.
- 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
- Individuals who voluntarily agree to participate in this clinical study and provide written informed consent
- Male or female adults aged 50 years or older at the time of consent
- Individuals who, in the opinion of the investigator, are capable of complying with the requirements of the study protocol Ocular Conditions
- Individuals with a BCVA equivalent of ETDRS 24 letters or more, as measured at the time of screening.
- Confirmed diagnosis, by the investigator, of active nAMD based on sufficiently clear ocular media and adequate pupillary dilation allowing...
You likely can't join if
- Any major illness or major surgical procedure within 1 month before screening.
- Any condition that, in the opinion of the investigator, constitutes a contraindication to the use of faricimab, may affect interpretation of study...
- History of active cancer within 12 months prior to screening, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin...
- Uncontrolled blood pressure, defined as systolic \>180 mmHg and/or diastolic \>100 mmHg while at rest at baseline. A repeat reading within the...
- Immune system abnormalities that may affect inflammatory biomarkers in aqueous humor (AH).
- History of severe allergic or anaphylactic reaction to biologic agents, or known hypersensitivity to any component of the faricimab injection...
See the full eligibility criteria
Who can join
- Individuals who voluntarily agree to participate in this clinical study and provide written informed consent
- Male or female adults aged 50 years or older at the time of consent
- Individuals who, in the opinion of the investigator, are capable of complying with the requirements of the study protocol Ocular Conditions
- Individuals with a BCVA equivalent of ETDRS 24 letters or more, as measured at the time of screening.
- Confirmed diagnosis, by the investigator, of active nAMD based on sufficiently clear ocular media and adequate pupillary dilation allowing acquisition of good quality retinal images for confirmation.
- Treatment naïve patients
- For PCV patients, presence of active polypoidal lesions in the macula as shown by Indocyanine green angiography (ICGA) AND presence of serosanguinous maculopathy
- For PCV patients, greatest liner dimension (GLD) of the total lesion area \<5400 μm as delineated by ICGA.
What rules you out
- Any major illness or major surgical procedure within 1 month before screening.
- Any condition that, in the opinion of the investigator, constitutes a contraindication to the use of faricimab, may affect interpretation of study results, or places the participant at high risk for treatment-related...
- History of active cancer within 12 months prior to screening, except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer, or prostate cancer with a Gleason score ≤6 (Grade Group 1) and...
- Uncontrolled blood pressure, defined as systolic \>180 mmHg and/or diastolic \>100 mmHg while at rest at baseline. A repeat reading within the screening window may be taken to confirm eligibility.
- Immune system abnormalities that may affect inflammatory biomarkers in aqueous humor (AH).
- History of severe allergic or anaphylactic reaction to biologic agents, or known hypersensitivity to any component of the faricimab injection, study-related procedures (including fluorescein and indocyanine green dyes)...
- Systemic treatment for suspected or active systemic infection at screening. Ongoing prophylactic antibiotic use may be acceptable at the investigator's discretion.
- Use of systemic medications known to have toxic effects on the lens, retina, or optic nerve within 6 months prior to screening or within 5 drug half-lives (whichever is longer), or expected future use of such...
- Receipt of systemic immunomodulatory therapy or immunosuppressive agents within 6 months prior to screening or within 5 drug half-lives (whichever is longer).
- Participation in another clinical study involving an investigational drug, investigational device, or other medical research within 3 months prior to screening, or concurrent participation in such a study.
- Pregnant or breastfeeding women.
- Women of childbearing potential planning to become pregnant during the study or within 3 months after the last dose of study treatment, or unwilling to use highly effective contraception methods\ throughout the study...
- Any ocular condition in the study eye that may interfere with the assessment of visual acuity, safety evaluation, or fundus imaging (e.g., advanced cataract).
- Any current ocular disease in the study eye that, in the opinion of the investigator, increases the procedural risk of intravitreal injection beyond standard expectations or may interfere with injection, how well it...
- Presence of fibrosis or atrophy involving ≥50% of the total lesion area and/or the fovea in the study eye, as determined by the investigator.
- Presence of retinal pigment epithelial (RPE) tear involving the macula in the study eye.
- High myopia with spherical equivalent refractive error \>6 diopters in the study eye. For participants with a history of refractive or cataract surgery, pre-surgical refractive error must not have exceeded -6 diopters.
- Presence of vitreous hemorrhage in the study eye at screening or baseline visits.
- History of other macular diseases in the study eye that are unrelated to nAMD but may lead to visual loss or cause intraretinal fluid (IRF) or subretinal fluid (SRF).
- History or clinical evidence of proliferative diabetic retinopathy, diabetic macular edema, or other retinal vascular diseases in the study eye, other than AMD.
- Any current ocular condition in the study eye (e.g., cataract) that, in the opinion of the investigator, may require medical or surgical intervention during the study period.
- History of prior intraocular surgery in the study eye, including but not limited to vitrectomy, glaucoma surgery, corneal transplant, radiation therapy, retinal detachment repair (e.g., scleral buckle or pneumatic...
- History of prior or ongoing treatment for macular neovascularization (MNV) or vitreomacular interface abnormalities in the study eye, including but not limited to intravitreal therapy (faricimab, other anti-VEGF agents...
- Presence of glaucoma in the study eye with uncontrolled intraocular pressure ≥25 mmHg despite pharmacological therapy.
- Presence of active ocular inflammation or suspected or active ocular or periocular infection in either eye at screening.
The study team makes the final eligibility decision.
Where it's taking place
- Seongnam, South Korea
- Seoul, South Korea
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 Seongnam, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.