Faricimab for high-frequent Aflibercept treated Neovascular age-related macular degeneration: a monocenter, randomized, double-masked comparator-controlled study (FAN study)
- Conditions
- Neovascular age-related macular degeneration
- Registration Number
- 2024-515377-10-00
- Lead Sponsor
- Medical University Of Graz, Medical University Of Graz
- Brief Summary
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.
- Detailed 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).
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 70
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate) proportion of eyes with at least one extension without retinal (intra- and subretinal) fluid within the time period baseline to 32 weeks (extension success rate)
- Secondary Outcome Measures
Name Time Method proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8 and ≥ 10 weeks at 32 weeks proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8 and ≥ 10 weeks at 32 weeks
maximum extended treatment interval without retinal (intra- and subretinal) fluid at 32 weeks maximum extended treatment interval without retinal (intra- and subretinal) fluid at 32 weeks
number of injections received during 32 weeks number of injections received during 32 weeks
proportion of eyes with maximum extended interval without retinal (intra-and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 and ≥12weeks at 56 weeks proportion of eyes with maximum extended interval without retinal (intra-and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 and ≥12weeks at 56 weeks
proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval) at 56 weeks proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval) at 56 weeks
maximum extended treatment interval without retinal (intra- and subretinal) fluid at 56 weeks maximum extended treatment interval without retinal (intra- and subretinal) fluid at 56 weeks
number of injections received during 1 year number of injections received during 1 year
mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 24 and 32 weeks mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 24 and 32 weeks
mean averaged EDTRS letter score between 24 and 32 weeks mean averaged EDTRS letter score between 24 and 32 weeks
mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 48 and 56 weeks mean change in EDTRS letter score from baseline to an averaged EDTRS letter score between 48 and 56 weeks
mean averaged EDTRS letter score between 48 and 56 weeks mean averaged EDTRS letter score between 48 and 56 weeks
proportion of eyes gaining ≥ 5 EDTRS letters from baseline to an averaged EDTRS letter score between 24 and 32 weeks proportion of eyes gaining ≥ 5 EDTRS letters from baseline to an averaged EDTRS letter score between 24 and 32 weeks
proportion of eyes loosing ≥5 EDTRS letters from baseline to an averaged EDTRS letter score between 24 and 32 weeks proportion of eyes loosing ≥5 EDTRS letters from baseline to an averaged EDTRS letter score between 24 and 32 weeks
proportion of eyes gaining ≥ 5 EDTRS letters from baseline to an averaged EDTRS letter score between 48 and 56 weeks proportion of eyes gaining ≥ 5 EDTRS letters from baseline to an averaged EDTRS letter score between 48 and 56 weeks
proportion of eyes loosing ≥5 EDTRS letters from baseline to an averaged EDTRS letter score between 48 and 56 weeks proportion of eyes loosing ≥5 EDTRS letters from baseline to an averaged EDTRS letter score between 48 and 56 weeks
mean change in low-luminance BCVA from baseline over time mean change in low-luminance BCVA from baseline over time
mean CST change from baseline (1mm EDTRS grid) to an averaged CST between 24 and 32 weeks mean CST change from baseline (1mm EDTRS grid) to an averaged CST between 24 and 32 weeks
mean CST change from baseline (1mm EDTRS grid) to an averaged CST between 48 and 56 weeks mean CST change from baseline (1mm EDTRS grid) to an averaged CST between 48 and 56 weeks
proportion of eyes with no intraretinal fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks proportion of eyes with no intraretinal fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks
proportion of eyes with no subretinal fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks proportion of eyes with no subretinal fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks
proportion of eyes with no retinal (intra- and subretinal) fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks proportion of eyes with no retinal (intra- and subretinal) fluid at baseline, last visit (completed interval) at or before 32 weeks and at or before 56 weeks
retinal nerve fiber analysis over time retinal nerve fiber analysis over time
incidence and severity of ocular/non-ocular adverse events incidence and severity of ocular/non-ocular adverse events
initial concentration of plasma VEGF-A, Ang-2 initial concentration of plasma VEGF-A, Ang-2
mean change in concentration of plasma VEGF-A, Ang-2 over time mean change in concentration of plasma VEGF-A, Ang-2 over time
change in NEI VFO-25 total score over time change in NEI VFO-25 total score over time
Trial Locations
- Locations (1)
Medical University Of Graz
🇦🇹Graz, Austria
Medical University Of Graz🇦🇹Graz, AustriaAndreas WedrichSite contact+4331638512394Andreas.wedrich@medunigraz.at