Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)

Medical University Of Graz1 site in 1 country33 target enrollmentSeptember 22, 2024

Overview

Phase: Phase III and phase IV (Integrated)
Intervention: Not specified
Conditions: Not specified
Sponsor: Medical University Of Graz
Enrollment: 33
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 aflibercept 8mg in terms of durability at 32 weeks by extending treatment interval in previous high-frequent faricimab and prior aflibercept 2mg treated neovascular age-related macular degeneration.

Registry

euclinicaltrials.eu

Start Date

September 22, 2024

End Date

TBD

Last Updated

last year

Investigators

Sponsor

Medical University Of Graz

Responsible Party

Principal Investigator

Coordination Center for Clinical Trials

Scientific

Medical University Of Graz

Eligibility Criteria

Inclusion Criteria

•prior participation in the FAN study
•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)
•≥ 4 previous intravitreal injections with faricimab
•eyes remaining on a treatment interval of ≤35 days and/or
•did/do not meet extension success with faricimab, hence had/has retinal (intra- and or subretinal) fluid at 6 weeks

Exclusion Criteria

•uncontrolled blood pressure (either/both systolic blood pressure >180mmHg, diastolic blood pressure >100mmHg)
•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)
•breast-feeding
•myocardial infarction or stroke within the last six months

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

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
number of injections received during 32 weeks
proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval) at 32 weeks
proportion of eyes extended to 6 weeks, without success (intra- and or subretinal fluid present) from baseline to 32 weeks
mean change in ETDRS letter score from baseline to an averaged ETDRS letter score between 24 and 32 weeks
mean averaged ETDRS letter score between 24 and 32 weeks
proportion of eyes gaining ≥ 5 ETDRS letters from baseline to an averaged ETDRS letter score between 24 and 32 weeks
proportion of eyes loosing ≥5 ETDRS letters from baseline to an averaged ETDRS letter score between 24 and 32 weeks
mean change in low-luminance BCVA from baseline over time
mean CST change from baseline (1mm ETDRS grid) to an averaged CST between 24 and 32 weeks
mean CST change from baseline to maximum extended interval without retinal (intra- and subretinal) fluid
proportion of eyes with no intraretinal fluid at baseline and final visit (completed interval) at or before 32 weeks
proportion of eyes with no subretinal fluid at baseline and final visit (completed interval) at or before 32 weeks
proportion of eyes with no retinal (intra- and subretinal) fluid at baseline and final visit (completed interval) at or before 32 weeks
retinal nerve fiber analysis over time
incidence and severity of ocular/non-ocular adverse events
mean change in concentration of plasma VEGF-A over time