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

Medical University of Graz

Status and phase: Completed; Phase 4

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Drug: Aflibercept 40 MG/ML; Drug: Faricimab 120 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT05941715

35-200 ex 22/23

2023-000037-32 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 70 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

group A: aflibercept first (part 1), switch to faricimab (part 2)

Active Comparator group

Description:

Aflibercept 2.0mg/0.05ml intravitreal will be administered from baseline through to the first visit at or after 32 weeks in a treat-and-extend regime. At the first visit at or after 32 weeks, faricimab 6.0mg/0.05ml intravitreal will be administered in a treat-and-extend regime through to the last visit before 56 weeks.

Treatment:

Drug: Faricimab 120 MG/ML

Drug: Aflibercept 40 MG/ML

group B: faricimab monotherapy

Experimental group

Description:

Faricimab 6.0mg/0.05ml intravitreal will be administered from baseline through to the last visit before 56 weeks in a treat-and-extend regime.

Treatment:

Drug: Faricimab 120 MG/ML