Faricimab for high-frequent Aflibercept treated Neovascular age-related macular degeneration: a monocenter, randomized, double-masked comparator-controlled study (FAN study)

Medical University Of Graz, Medical University Of Graz1 site in 1 country70 target enrollmentNovember 18, 2024

DrugsBAY86-5321 immunoglobulin G1-kappa/lambda with domain crossover, anti-[Homo sapiens VEGFA (vascular endothelial growth factor A, VEGF-A, VEGF)] and anti-[Homo sapiens ANGPT2 (angiopoietin 2, Ang2)], humanized and Homo sapiens monoclonal antibody, bispecific BAY 86-5321 ABP 938 RG-7716 (ANTIVASCULAR ENDOTHELIAL GROWTH FACTOR/ANTI-ANGIOPOIETIN 2 BISPECIFIC ANTIBODY)RO6867461 Vabysmo 120 mg/mL solution for injection BAY 86-5319 VEGF TRAP AVE0005 Recombinant human anti-human VEGF-A and anti-human Ang-2 mAb Eylea 40 mg/mL solution for injection in pre-filled syringe RG-7716

Overview

Phase: Phase III and phase IV (Integrated)
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical University Of Graz, Medical University Of Graz
Enrollment: 70
Locations: 1
Primary Endpoint: 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)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

euclinicaltrials.eu

Start Date

November 18, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Investigators

Sponsor

Medical University Of Graz, Medical University Of Graz

Responsible Party

Principal Investigator

Coordination center for Clinical Trials

Scientific

Medical University Of Graz

Eligibility Criteria

Inclusion 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

Exclusion Criteria

•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)

Outcomes

Primary Outcomes

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 Outcomes

mean change in concentration of plasma VEGF-A, Ang-2 over time
proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8 and ≥ 10 weeks at 32 weeks
change in NEI VFO-25 total score over time
maximum extended treatment interval without retinal (intra- and subretinal) fluid at 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 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
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 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 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 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 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 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
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 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
incidence and severity of ocular/non-ocular adverse events
initial concentration of plasma VEGF-A, Ang-2