Comparing 8-week and 12-week follow-up intervals for treating wet AMD with faricimab
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study
This study is testing whether patients with wet age-related macular degeneration can benefit more from follow-up treatments every 8 weeks or every 12 weeks after their initial injections of faricimab.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Faculty Hospital Kralovske Vinohrady Government |
| Drugs / interventions | faricimab |
| Locations | 1 site (Prague) |
| Trial ID | NCT06875245 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include treatment-naïve patients with active CNV in the macula and a best corrected visual acuity between 70 to 35 ETDRS letters.
Not a fit: Patients with recent myocardial infarction or stroke, or those with significant complications in the study eye, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could optimize treatment intervals for patients with wet AMD, potentially improving visual outcomes and reducing treatment burden.
How similar studies have performed: Other studies have shown success with similar anti-VEGF treatment approaches, but this specific comparison of follow-up intervals is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Prague
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.