RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Faricimab Injection [Vabysmo] for Macular Degeneration

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.

Official registry: https://clinicaltrials.gov/study/NCT07367282 · Junyeop Lee · enrollment listed as 64

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Faricimab Injection [Vabysmo]. The registry lists allocation as na. 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.

They plan to enroll about 64 people at 5 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Phase IV, Prospective, Open-label, Single-arm Clinical Trial to Evaluate the Efficacy of Faricimab and Biomarker Assessment in Patients With Neovascular Age-related Macular Degeneration

Interventions: Faricimab Injection [Vabysmo]

Primary outcome (registry wording): ANG-2 level in aqueous humour (AH)

Who it is for (from inclusion criteria)

Ages 50 Years to any
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
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

Who the registry excludes

Any major illness or major surgical procedure within 1 month before screening
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 stable PSA levels for \>12 months
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)
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 medications
Receipt of systemic immunomodulatory therapy or immunosuppressive agents within 6 months prior to screening or within 5 drug half-lives (whichever is longer)

Public study contact (from the registry)

Junyeop Lee, PhD

82-2-3010-3975

j.lee.amc@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

5 listed

Seoul National University Bundang Hospital — Seongnam, South Korea (recruiting)
Asan Medical Center — Seoul, South Korea (recruiting)
Kyung Hee University Medical Center — Seoul, South Korea (not_yet_recruiting)
Samsung Medical Center — Seoul, South Korea (recruiting)
Seoul St. Mary's Hospital — Seoul, South Korea (not_yet_recruiting)

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FAQ about this NCT record

Is NCT07367282 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07367282?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07367282?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary