Condition: Macular Degeneration · Sponsor: Junyeop Lee
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 a…
This description comes directly from the study's public registry record.
Junyeop Lee, PhD · 82-2-3010-3975 · j.lee.amc@gmail.com
Always discuss trial participation with your own doctor first.
| 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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Source record: clinicaltrials.gov/study/NCT07367282