NCT06875245RecruitingPhase 4
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals
Comparing Efficacy of 8-Week and 12-Week Faricimab Initial Follow-Up Treatment Intervals Following 4 Loading Doses - Prospective Randomised Study
Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 30 Oct 2023
- Start date
- 31 Mar 2023
- Primary completion date
- Apr 2025
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Diseases
- Macular degeneration
- NCT number
- NCT06875245
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 31 Mar 2023 to the primary completion date, Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current conditions of the study eye:
Other illness
- Myocardial Infarction or Stroke in the last 3 months
- subretinal haemorrhage comprising more than 25% of the lesion in the study eye
- idiopathic or autoimmune uveitis in the study eye
- diabetic retinopathy, diabetic macular edema or any other retinal vascular disease in the study eye
- extraocular or periocular infection or inflammation (e.g. blepharitis, keratitis, conjunctivitis, scleritis, etc.) in any eye at the time of screening or baseline visit
- any intraocular infection or inflammation in any eye during 12 weeks (84 days) before the screening visit
- allergy or hypersensitivity to any component contained in the study drug
Other
- 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
- uncontrolled glaucoma in the study eye defined as IOP of more than 25 mmHg despite the antiglaucoma treatment
- 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.)
- significant opacities of the ocular media in the study eye including cataract, which can interfere with BCVA assessment or OCT examination
- pregnant or breastfeeding women
Who the study is looking for
- 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
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Ophthalmology, Faculty hospital Kralovske Vinohrady Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.