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Evaluate the Efficacy of Faricimab in Patients With Neovascular Age-related Macular Degeneration
Sponsor: Junyeop Lee
Summary
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. If both eyes are eligible, the eye with the worst best-corrected visual acuity (BCVA) at screening will be chosen. However, if the investigator determines that the other eye requires more urgent treatment for clinical reasons, that eye may be selected as the study eye. After screening assessments and evaluation based on inclusion/exclusion criteria, eligible subjects will be enrolled. Vabysmo® 6 mg (0.05 mL) will be administered via intravitreal injection every 4 weeks (monthly) for a total of 4 doses during the initial loading period. After the loading dose, patients will undergo disease activity assessment based on imaging and visual acuity (VA) outcomes followed by the IP administration at Week 20. The treatment interval will be determined based on disease activity assessed at Week 20, depending on the results, the subsequent administration may be scheduled at Week 28 or Week 32, at the investigator's discretion. Thereafter, the dosing interval may be further adjusted in 4-week increments, either extended or shortened, according to imaging and visual outcomes. Throughout the clinical study, patients will need to visit the study site at least 10 times, including the screening visit. The number of intravitreal injections administered will be 4 doses during the initial loading period and up to 5 doses during the treat-and-extend (T\&E) period (Weeks 20, 28, 36, 44, 52). Thus, the total number of injections during the study will range from a minimum of 7 to a maximum of 9 injections. If the non-study eye also has nAMD, treatment with a locally approved therapy may be administered outside the scope of this study.
Official title: 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
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
64
Start Date
2026-06-29
Completion Date
2028-12-31
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Faricimab Injection [Vabysmo]
Faricimab Injection 6mg 0.05 cc
Locations (5)
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Kyung Hee University Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea