NCT05941715CompletedPhase 4
Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration
Faricimab for High-frequent Aflibercept Treated Neovascular Age-related Macular Degeneration: a Monocenter, Randomized, Double-masked Comparator-controlled Study (FAN)
Source: ClinicalTrials.gov · Last updated 6 Jun 2025
Brief summary (registry, in English)
Study purpose: To evaluate if previously high-frequent (3-5 weekly) aflibercept treated neovascular age-related macular degeneration (nAMD) can be extended in their treatment interval when switched to faricimab. Primary objective: To assess the efficacy of faricimab compared to aflibercept in terms of durability at 32 weeks by extending treatment interval in previous high-frequent aflibercept treated nAMD.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 70 (actual)
- First submitted
- 19 Jun 2023
- Start date
- 4 Jul 2023
- Primary completion date
- 25 Sept 2024
- Lead sponsor
- Medical University of Graz
- Diseases
- Macular degeneration
- NCT number
- NCT05941715
- EU CT number
- 2024-515377-10-00
- EudraCT number
- 2023-000037-32
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 70
- From 4 Jul 2023 to the primary completion date, 25 Sept 2024
- 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.
Criteria the registry did not label
- Ocular inclusion criteria:
- MNV due to AMD (nAMD)
- BVCA between and including 19 and 75 letters (Snellen equivalent approximately 20/400 to 20/32)
- ≥ 7 previous intravitreal injections with anti-VEGF
- the last ≥ 4 consecutive intravitreal injections with aflibercept
- the last aflibercept injections within the last 35 days
- interval between the last 2 aflibercept injections ≤ 35 days
- Ocular exclusion criteria:
- MNV due to other causes than nAMD
- polypoidal choroidal neovascularization
- retinal pigment epithelial rip/tear
- subretinal hemorrhage of \> 50% of the lesion, involving the fovea
- any macular pathology other than AMD causing structural changes of the macula and thereby affecting vision
- any active intra-/periocular infection/inflammation of the study eye
- uncontrolled glaucoma under medication (IOP \>25mmHg)
- cataract surgery of the study eye within the last 3 months
- previous intraocular surgery of the study eye other than cataract surgery or intravitreal injections with anti-VEGF (e.g. vitrectomy, corneal transplant, glaucoma surgery)
- any previous laser therapy of the study eye other than Yag (yttrium aluminium garnet) laser capsulotomy (e.g. panretinal photocoagulation, verteporfin photodynamic therapy)
- refractive error of more than -6 diopters myopia
- vitreous hemorrhage
- retinal detachment
- General exclusion criteria
- use of long-term systemic corticosteroids within the last 3 months
- uncontrolled blood pressure (either/both systolic blood pressure \>180mmHg, diastolic blood pressure \>100mmHg)
- pregnancy (pre-menopausal women MUST take a pregnancy test at time of initiation)
- breast-feeding
- myocardial infarction or stroke within the last six months
- concomitant participation in another clinical study with investigational medicinal products
- a known allergy or hypersensitivity towards eye drops needed for the examinations planned during the study, and/or the intravitreal procedure.
- a known allergy or hypersensitivity against fluorescein / indocyanine green used during angiography
- a known allergy or hypersensitivity towards any of the components of the study drug
Age in the registry: 50 years to - · 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 |
|---|---|---|---|
| Medical University of Graz Coordinator of this site? Confirm its status | Graz | Austria | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.