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Examination of the relationship between prolonging the administration interval of faricimab and anti-Ang-2 effects in nAMD patients

ARIAKE study

Kawaji Takahiro

Sato eye & internal medicine clinic

4160-270 Arao Arao-shi Kumamoto, 864-0041 JAPAN

kawag@white.plala.or.jp

Kawaji Takahiro

Sato eye & internal medicine clinic

4160-270 Arao Arao-shi Kumamoto, 864-0041 JAPAN

+81-968-65-5900

kawag@white.plala.or.jp

Recruiting

Aug. 13, 2024

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

diagnostic purpose

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.

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)

Both

Neovascular age-related macular degeneration

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 subject to the Clinical Research Act.

Patients participating in this study will receive intravitreal injections of 6.0 mg faricimab for approximately one year. During the induction period, all patients will receive three or four consecutive doses of faricimab once every four weeks (Q4W) (however, the fourth dose will be omitted depending on the re-administration criteria*). The dosing schedule from W12 onwards will be determined based on the re-administration criteria*.

From W12 onwards, the dosing interval will be extended until the re-administration criteria* are met. However, the maximum dosing interval will be once every 24 weeks (Q24W).

If the re-administration criteria* are met on the visit date after W12, the following regimen will be used from then on (Figure 1.1 1).

1) Dosing interval
The drug will be administered immediately on the visit date on which the re-administration criteria* are met. Next, the drug is administered at intervals 4 weeks shorter than the period from the previous administration to the visit date when the readministration criteria* were met. However, the shortest administration interval is once every 8 weeks (Q8W). After that, unless the readministration criteria* are met, the administration interval from the next administration onwards is extended by 4 weeks. However, the longest administration interval is Q24W.
2) Visit interval
The patient will visit the hospital every 4 weeks until the readministration criteria are met, and then visit at a frequency according to the administration interval. In addition, patients will visit the hospital for evaluation at W32 and W56. In addition, patients will visit the hospital for examination on W1.
* The readministration criteria are defined as cases where significant** IRF or SRF is found in the pathology. Note that the judgment of the readministration criteria is performed only on the target eye.

age-related macular degeneration

D008268

D016430

Switch subjects; Interval until re administration criteria are met after the induction period (extention from before switching)
Naive subjects; administration interval at W56

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

+81-3-3964-1141

Aug. 06, 2024

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