Comparing 8-week and 12-week follow-up intervals for treating wet AMD with faricimab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of two different follow-up treatment intervals (8 weeks vs. 12 weeks) after an initial loading phase of four monthly injections of faricimab for patients with wet age-related macular degeneration (AMD). Patients diagnosed with active choroidal neovascularization (CNV) will be randomized into two groups, with one group receiving follow-up after 8 weeks and the other after 12 weeks. The study will assess visual acuity and retinal thickness over a period of 44 to 56 weeks to determine the effectiveness of each treatment regimen. Both groups will follow a treat-and-extend approach after the initial loading phase.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Active treatment naïve CNV (Type 1, Type 2, or Type 3) in the macula including fovea diagnosed on OCT and OCTA

BCVA between 70 to 35 ETDRS letters (approx. 20/40 to 20/200 Snellen equivalent) decrease in BCVA caused primarily by the CNV in the study eye

presence of intra- or subretinal fluid or PED in the central 1 mm of the macula on the OCT

patient capable of signing the informed consent

Exclusion Criteria:

Myocardial Infarction or Stroke in the last 3 months

Previous or current conditions of the study eye:

1. subretinal haemorrhage comprising more than 25% of the lesion in the study eye
2. scar or fibrosis comprising more than 50% of the lesion in the study eye
3. presence of retinal pigment epithelium (RPE) tears or ruptures in the central 1 mm of the macula in the study eye
4. total lesion size more than 8 papillary diameters (PD) as per OCT and FP examination
5. uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
6. idiopathic or autoimmune uveitis in the study eye
7. other pathologies in the macula of the study eye unrelated to AMD which can be expected to influence the BCVA (e.g. macular hole, epiretinal membrane, etc.)

k. significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination

n. diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye

o. extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit

p. any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit

q. allergy or hypersensitivity to any component contained in the study drug

r. pregnant or breastfeeding women

Where it's running

• Department of Ophthalmology, Faculty hospital Kralovske Vinohrady
  Prague, Czechia Recruiting

Study contacts

• Principal investigator: Martin Pencak, MD — +420 267 16 3637
• Study coordinator: Martin Pencak, MD
• Email: martin.pencak@fnkv.cz
• Phone: +420 267 16 3637

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Faricimab for subretinal hyper-reflective material in AMD

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.