2024-515497-26-00CompletedPhase 4
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)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 22 Sept 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 22 Jul 2024
- Start date
- 24 Oct 2024
- Lead sponsor
- Medical University Of Graz
- Diseases
- Macular degeneration
- EU CT number
- 2024-515497-26-00
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 33
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- uncontrolled glaucoma under medication (IOP >25mmHg)
- concomitant participation in another clinical study with investigational medicinal products
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Graz | Graz | Austria | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.