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Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals

ConditionWet Age-related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFaculty Hospital Kralovske Vinohrady

About this trial

This is a prospective, randomized study that compares 8-week and 12-week follow-up intervals after the 4 monthly injections in the loading phase. Patients with active CNV confirmed on optical coherence tomography (OCT) and OCT angiography (OCTA) will be randomized into two groups and followed for 44 to 56 weeks.

Patients in the first group will receive 4 injections of faricimab every 4 weeks, with the next visit and injection after 8 weeks, followed by a treat-and-extend regimen with a minimal interval of 8 weeks and a maximal interval of 16 weeks.

Patients in the second group will also receive 4 loading doses with the next visit after an extended 12-week interval. Following treatment, patients in this group will be on the same treat-and-extend regimen as patients in the first group. The study will compare best corrected visual acuity (BCVA), central retinal thickness (CRT) on OCT, and the number of injections between both groups.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

subretinal haemorrhage comprising more than 25% of the lesion in the study eye

scar or fibrosis comprising more than 50% of the lesion in the study eye

presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye

total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination

Trial design

Design model

Parallel

Treatments tested in this trial

  • Faricimab Injection

    Drug

    Intravitreal Injection

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Group 1, 8-WeekExperimental treatment 1 intervention
Group B: Group 2, 12-WeekExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in CRT

Change in central subfield thickness (CST) over time as measured by SD-OCT

Time frame
from baseline up to 56 weeks
2

Patients with intraretinal or subretinal fluid or serous pigment epithelium detachment after loading

Number of patients with subretinal, intraretinal fluid or pigment epithelium detachment (PED) at week 20 (Group 1) or week 24 (Group 2)

Time frame
From baseline to week 20 (Group 1) or week 24 (Group 2)

Secondary outcomes

1

Change from baseline in BCVA

Change in best-corrected visual acuity over time as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters

Time frame
From baseline up to 56 weeks
2

Presence of fluid

Proportion of patients with presence of central retina intraretinal fluid, subretinal fluid, and both at final study visit

Time frame
From baseline up to 56 weeks
3

Number of injections

Number of faricimab injections received during the study duration.

Time frame
From baseline up to 56 weeks
4

Treatment interval

The proportion of patients on a every 4 weeks (Q4w) to every 8 weeks (Q8W), Q8W to every 12 weeks (Q12W), and Q12W to every 16 weeks (Q16W) treatment interval during the study

Time frame
From baseline up to 56 weeks

Other outcomes

Sponsors and contacts

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

Faculty Hospital Kralovske Vinohrady

Lead sponsor

Source ClinicalTrials.gov
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