Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration: a Monocenter, Randomized, Double-masked Comparator-controlled Study (FAN)

35-200 ex 22/23

Study purpose: To evaluate if previously high-frequent (3-5 weekly) aflibercept treated neovascular age-related macular degeneration (nAMD) can be extended in their treatment interval when switched to faricimab. Primary objective: To assess the efficacy of faricimab compared to aflibercept in terms of durability at 32 weeks by extending treatment interval in previous high-frequent aflibercept treated nAMD.

2023-07-04

2024-10-01

2025-02-01

Active (not recruiting)

Early phase I

70

Ocular inclusion criteria: * MNV due to AMD (nAMD) * BVCA between and including 19 and 75 letters (Snellen equivalent approximately 20/400 to 20/32) * ≥ 7 previous intravitreal injections with anti-VEGF * the last ≥ 4 consecutive intravitreal injections with aflibercept * the last aflibercept injections within the last 35 days * interval between the last 2 aflibercept injections ≤ 35 days Ocular exclusion criteria: * MNV due to other causes than nAMD * polypoidal choroidal neovascularization * retinal pigment epithelial rip/tear * subretinal hemorrhage of \> 50% of the lesion, involving the fovea * any macular pathology other than AMD causing structural changes of the macula and thereby affecting vision * any active intra-/periocular infection/inflammation of the study eye * uncontrolled glaucoma under medication (IOP \>25mmHg) * cataract surgery of the study eye within the last 3 months * previous intraocular surgery of the study eye other than cataract surgery or intravitreal injections with anti-VEGF (e.g. vitrectomy, corneal transplant, glaucoma surgery) * any previous laser therapy of the study eye other than Yag (yttrium aluminium garnet) laser capsulotomy (e.g. panretinal photocoagulation, verteporfin photodynamic therapy) * refractive error of more than -6 diopters myopia * vitreous hemorrhage * retinal detachment General exclusion criteria * use of long-term systemic corticosteroids within the last 3 months * uncontrolled blood pressure (either/both systolic blood pressure \>180mmHg, diastolic blood pressure \>100mmHg) * pregnancy (pre-menopausal women MUST take a pregnancy test at time of initiation) * breast-feeding * myocardial infarction or stroke within the last six months * concomitant participation in another clinical study with investigational medicinal products * a known allergy or hypersensitivity towards eye drops needed for the examinations planned during the study, and/or the intravitreal procedure. * a known allergy or hypersensitivity against fluorescein / indocyanine green used during angiography * a known allergy or hypersensitivity towards any of the components of the study drug

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 70, 'type': 'ACTUAL'}}

2024-01-18