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Faricimab for high-frequent Aflibercept treated Neovascular age-related macular degeneration: a monocenter, randomized, double-masked comparator-controlled study (FAN study)
EU CTIS ID: 2024-515377-10-00
What this study is testing
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 neovascular age-related macular degeneration.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- signed written informed consent
- willingness and ability to comply with clinic visits and study-related procedures
- ≥50 years of age
- 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
You likely can't join if
- use of long-term systemic corticosteroids within the last 3 months
- 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
See the full eligibility criteria
- signed written informed consent
- willingness and ability to comply with clinic visits and study-related procedures
- ≥50 years of age
- 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
- use of long-term systemic corticosteroids within the last 3 months
- 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)
- uncontrolled blood pressure (either/both systolic blood pressure >180mmHg, diastolic blood pressure >100mmHg)
- refractive error of more than -6 diopters myopia
- vitreous hemorrhage
- retinal detachment
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.