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Faricimab Quarterly Maintenance for Neovascular Age Related Macular Degeneration

ConditionMacular Degeneration Choroidal Neovascularization
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorHospital Authority, Hong Kong

About this trial

We aimed to investigate the success rate of a planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab, for nAMD to achieve stability without recurrence at a tertiary eye centre.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

eyes that received any anti-VEGF therapy in the prior six months,

eyes with other disease entities (e.g., diabetic macula oedema, retinal vein occlusions, central serous chorioretinopathy, myopicmacular neovascularisation),

concurrent macula laser (except photodynamic therapy) and ocular surgery (e.g., cataract surgery or vitrectomy) in the prior six months and the study period.

Trial design

Design model

Single group

Treatments tested in this trial

  • Faricimab Injection [Vabysmo]

    Drug

    A planned quarterly (every 12-16 weeks) faricimab injection schedule, following a disease inactivity achieved after initial 2-4 loading doses of faricimab. This intervention schedule is not specifically studied in other literature, although similar schedule exist.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Faricimab treatment armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual acuity

The primary outcome is the change from baseline in best-corrected visual acuity (BCVA) at week 52.

Time frame
52 weeks

Secondary outcomes

1

Anatomical success

Anatomical success was defined as no increase in disease activity of the AMD on clinical examination or OCT throughout the study period while remaining on the quarterly dosing schedule, without the need to shorten the treatment interval.

Time frame
52 weeks
2

Functional success

Functional success was characterised by a loss of fewer than five ETDRS letters, without the need to shorten the treatment interval.

Time frame
52 weeks
3

Maintenance treatment failure

Maintenance treatment failure was defined as an increase in disease activity during the quarterly dosing maintenance stage, i.e. new macular haemorrhage, neovascularisation, and/or an increase in OCT biomarkers for neovascular activity, and thus a decision for rescue treatment with shorter treatment intervals.

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Authority, Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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