Evaluate the Efficacy of Faricimab in Patients With Neovascular Age-related Macular Degeneration
ConditionMacular Degeneration
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorJunyeop Lee
About this trial
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.
Eligibility criteria
Qualifiers
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
Individuals with a BCVA equivalent of ETDRS 24 letters or more, as measured at the time of screening.
Disqualifiers
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 complications, based on medical history, non-diabetic metabolic abnormalities, physical examination findings, or past/current clinical laboratory results.
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.
Trial design
Treatments tested in this trial
- Faricimab Injection [Vabysmo]
Treatment groups
64 Participants
are divided into 1 treatment groupSponsors and collaborators
Junyeop Lee
Lead sponsor
Asan Medical Center
Sponsor institution
Source ClinicalTrials.gov