Aflibercept 8mg for high-frequent Faricimab and prior Aflibercept 2mg treated Neovascular age-related macular degeneration: a monocenter, single-arm, open-label extension study (A-FAN)
Key facts
- Where
- Graz, AusztriaSee the site
- Phase
- 4. fázis
Where in Ausztria
- Medical University of GrazGraz, AusztriaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Medical University Of Graz
- Trial code
- EU 2024-515497-26-00
- Record updated
- 2024. szeptember 22.
- Original description
To assess the efficacy of aflibercept 8mg in terms of durability at 32 weeks by extending treatment interval in previous high-frequent faricimab and prior aflibercept 2mg treated neovascular age-related macular degeneration.Read full original descriptionShow less
To assess the efficacy of aflibercept 8mg in terms of durability at 32 weeks by extending treatment interval in previous high-frequent faricimab and prior aflibercept 2mg treated neovascular age-related macular degeneration.
Inclusion: prior participation in the FAN study; signed written informed consent; willingness and ability to comply with clinic visits and study-related procedures; ≥50 years of age; MNV due to AMD (nAMD); BVCA between and including 19 and 75 letters (Snellen equivalent approximately 20/400 to 20/32); ≥ 4 previous intravitreal injections with faricimab; eyes remaining on a treatment interval of ≤35 days and/or; did/do not meet extension success with faricimab, hence had/has retinal (intra- and or subretinal) fluid at 6 weeks.
Exclusion: uncontrolled glaucoma under medication (IOP >25mmHg); concomitant participation in another clinical study with investigational medicinal products; subretinal hemorrhage of > 50% of the lesion, involving the fovea; any active intra-/periocular infection/inflammation of the study eye; myocardial infarction or stroke within the last six months; 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 towards any of the components of the study drug; Persons unable to give consent or cannot understand the purpose of the study (dementia, etc.), or should be excluded by investigator's decision; uncontrolled blood pressure (either/both systolic blood pressure >180mmHg, diastolic blood pressure >100mmHg); MNV due to other causes than nAMD; polypoidal choroidal neovascularization; retinal pigment epithelial rip/tear; any macular pathology other than AMD causing structural changes of the macula and thereby affecting vision; pregnancy; breast-feeding; treatment interval ≥ 6weeks without retinal (intra- and/or subretinal) fluid on OCT.