Neovascular age-related macular degeneration age-related macular degeneration
Conditions
Interventions
This study is an unmasked, single-arm, single-center interventional study to examine the efficacy and safety of faricimab dosing regimens in patients with nAMD. This study is a specific clinical study
Sponsors
Kawaji Takahiro
Tsujimura Jun
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Selection Criteria Patients who are willing and able to provide signed informed consent. Patients who are 50 years or older at the time of signing the informed consent. Patients who are able and willing to attend all scheduled visits and undergo all scheduled tests. Selection Criteria for the Target Eye Only one eye will be designated as the target eye. If both eyes are deemed eligible, the eye with the worse BCVA at screening will be selected as the target eye, unless the principal investigator or sub-investigator determines that the other eye is more suitable for the study treatment. Age-related macular degeneration (nAMD) with subfoveal choroidal neovascularization. Patients with active lesions affecting the foveal area (such as IRF, SRF) as evaluated by OCT-A or OCT. Patients with a visual acuity (decimal visual acuity) of 1.0 to 0.05 in the pre-treatment vision test conducted on Day1. Patients with sufficiently clear intermediate media and adequately dilated pupils to allow for high-quality color fundus photographs (CFP) and other imaging tests. Patients who have previously received intravitreal injections of other anti-VEGF drugs (switch patients) with being 8-12 weeks apart. *However, the interval between the second-to-last dose and the previous dose is allowed within a range of minus 2 to 2 weeks. In addition, the date on which the attending physician determines that the patient's condition has worsened during previous treatment and that administration of an anti-VEGF drug is necessary will be considered the "disease activity confirmation date."The date on which the attending physician determines that anti-VEGF drug administration is necessary due to disease progression during prior treatment is defined as the "disease activity confirmation date." Ideally, the disease activity confirmation date and the administration date should be the same. If they are on different dates due to clinical reasons, administration should be performed as soon as possible (within 2 weeks). In such cases, the period from the previous administration date to the disease activity confirmation date is considered the "injection interval," and if this interval is 8-12 weeks, the patient can be included in the study.
Exclusion criteria
Exclusion criteria: 1 General Exclusion Criteria 1. Patients with a history of severe allergic or anaphylactic reactions to biologics or known hypersensitivity to components of faricimab, mydriatic eye drops, anesthetics, or antibiotics. 2. Patients with a history or current clinical test findings that contraindicate the use of faricimab or that the principal investigator or co investigator suspects may affect the interpretation of the study results or may increase the risk of complications. 3. Patients receiving systemic treatment for suspected or active systemic infection. 4. Patients with poorly controlled hypertension (defined as resting systolic blood pressure over 180 mmHg and or diastolic blood pressure over 100 mmHg). If the first measurement during the screening period exceeds these values, the measurement may be repeated on the same day or on another day during the screening period. 5. Patients who have had a stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1 Patients who need to continue to use the following prohibited concomitant drugs or treatments. Systemic administration of anti VEGF drugs Systemic drugs known to cause macular edema (e.g., fingolimod, tamoxifen) Intravitreal administration of anti VEGF drugs (other than faricimab) to the target eye Intravitreal, periocular (sub Tenon), or habitual local administration of steroids to the target eye Photodynamic therapy (PDT) to the target eye Micropulse and local or lattice photocoagulation to the target eye Vitreous surgery or PRP to the target eye Kallidinogenase (for improving symptoms of retinal choroidal circulatory disorders) Other experimental treatments (excluding those with vitamins and minerals)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Switch subjects; Interval until re administration criteria are met after the induction period (extention from before switching) Naive subjects; administration interval at W56 | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity, central subfield thickness (CST) presence or absence of fluid at each time point, and proportion of each dosing interval at W32 and W56 The following items at each time point Best corrected visual acuity (BCVA) and change from baseline in BCVA (logMAR) CST and change from baseline in CST Percentage of patients without intraretinal fluid (IRF), without subretinal fluid (SRF), or without both | — |
Contacts
Public ContactTakahiro Kawaji
Sato eye & internal medicine clinic
Outcome results
None listed