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Completed

NCT Number: NCT05941715

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophthalmolgy, Medical University Graz

Graz, Styria, 8036, Austria

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept 40 MG/ML

Drug

treat-and-extend

Other names: Eylea®

Faricimab 120 MG/ML

Drug

treat-and-extend

Other names: Vabysmo®

Primary outcomes

  1. 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)

    Time frame: at 32 weeks

    Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.

Secondary outcomes

  1. Proportion of eyes with maximum extended interval without retinal (intra- and subretinal) fluid of ≥ 6, ≥ 8, ≥ 10 weeks and (≥ 12weeks)

    Time frame: at 32 weeks and 56 weeks

    Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.

  2. Maximum extended treatment interval without retinal (intra- and subretinal) fluid

    Time frame: at 32 weeks and 56 weeks

    Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.

  3. Number of injections received

    Time frame: during 32 weeks and 1 year

  4. Proportion of eyes remaining on a 4-weekly interval from baseline to last visit (completed interval)

    Time frame: at 32 weeks and 56 weeks

    Treatment is administered at each visit. The interval between treatments is based on a treat and extend regime. The first interval between treatments, from baseline, is 4 weeks. Intra- and subretinal fluid are assessed at each visit with optical coherence tomography (OCT). Should no intra- and subretinal fluid be present on OCT, the treatment interval to the next visit is extended by 2 weeks. Is intra- and or subretinal fluid present on OCT the treatment interval to the next visit is reduced by 2 weeks. The minimum treatment interval is 4 weeks, the maximum treatment interval is 12 weeks.

Other outcomes

  1. Mean change in ETDRS letter score

    Time frame: from baseline to an averaged EDTRS letter score between 24-32 weeks and between 48-56 weeks

    Best Corrected Visual Acuity (BCVA) is measured via Early Treatment Diabetic Retinopathy Severity (ETDRS) charts. The ETDRS letter score ranges from 0 to 100 (best score).

  2. Mean averaged ETDRS letter score

    Time frame: between 24-32 weeks and between 48-56 weeks

    Best Corrected Visual Acuity (BCVA) is measured via Early Treatment Diabetic Retinopathy Severity (ETDRS) charts. The ETDRS letter score ranges from 0 to 100 (best score).

  3. Proportion of eyes gaining ≥ 5 EDTRS letters

    Time frame: from baseline to an averaged ETDRS letter score between 24-32 weeks and between 48-56 weeks

  4. Proportion of eyes loosing ≥5 EDTRS letters

    Time frame: from baseline to an averaged ETDRS letter score between 24-32 weeks and between 48-56 weeks

  5. Mean change in low-luminance Best Corrected Visual Acuity (BCVA)

    Time frame: from baseline to last visit at or before 32 weeks and last visit at or before 56 weeks

  6. Mean change in central subfield thickness (CST)

    Time frame: from baseline to an averaged CST between 24-32 weeks and between 48-56 weeks

    CST is measured using optical coherence tomography (OCT).

  7. Proportion of eyes with no intraretinal fluid

    Time frame: at baseline, last visit at or before 32 weeks and at or before 56 weeks

    Intraretinal fluid is assessed via optical coherence tomography (OCT).

  8. Proportion of eyes with no subretinal fluid

    Time frame: at baseline, last visit at or before 32 weeks and at or before 56 weeks

    Subretinal fluid is assessed via optical coherence tomography (OCT).

  9. Proportion of eyes with no intra- and subretinal fluid

    Time frame: at baseline, last visit at or before 32 weeks and at or before 56 weeks

    Intra- and subretinal fluid is assessed via optical coherence tomography (OCT).

  10. Retinal nerve fiber layer (RNFL) thickness

    Time frame: at baseline, last visit at or before 32 weeks and last visit at or before 56 weeks

    RNFL thickness is assessed via optical coherence tomography (OCT).

  11. Concentration of plasma vascular endothelial growth factor A (VEGF-A) and Angiopoietin-2 (Ang-2)

    Time frame: at baseline, one week after baseline, four weeks after baseline and last visit at or before 32 weeks

    Plasma VEGF-A and Ang-2 is determined using a validated enzyme-linked immunosorbent assay (ELISA).

  12. Patient-reported vision-related functioning and quality of life

    Time frame: at screening, last visit at or before 32 weeks and last visit at or before 56 weeks

    Patient-reported vision-related functioning and quality of life is assessed via National Eye Institute Visual Function Questionnaire (VFQ-25). VFQ-25 score ranges from 0 to 100 (highest score).

  13. Presence of safety outcomes

    Time frame: from baseline through to week 56

    Rates of adverse events (AE's) and serious adverse events (SAE's) are given.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration: a Monocenter, Randomized, Double-masked Comparator-controlled Study (FAN)

Acronym: FAN

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 12, 2023
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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