Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration

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

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.

There is a subgroup of nAMD patient requiring monthly interventions, when applying as needed and treat-and-extend treatment strategies. A burden for both patient/caregivers and health care systems. More durable treatment options are needed to increase the quality of life for these nAMD patients, as well as to make human resources available for the growing elderly AMD population requiring treatment.

The FAN study is a randomized, double-masked, 2-arm (comparator-controlled), phase-IV, monocenter study with a primary endpoint at 32 weeks. The study is conducted into 2 parts. Patients will receive either aflibercept or faricimab via treat-and-extend principle until the primary endpoint (part 1). As mentioned, the main objective is to assess the durability of both drugs in this particular subgroup of nAMD patients. In part 2 of the study, starting at or after 32 weeks, all patients will receive faricimab via treat-and-extend until the end of the study (56 weeks).

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