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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)
EU CTIS ID: 2024-515497-26-00
What this study is testing
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.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
- 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
See the full eligibility criteria
- 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
- 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
- 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)
- pregnancy
- 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 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
- treatment interval ≥ 6weeks without retinal (intra- and/or subretinal) fluid on OCT
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.