Two initial aflibercept 8 mg loading doses in treatment-naive neovascular AMD
Key facts
- Where
- Graz, AusztriaSee the site
- Phase
- 4. fázis
Where in Ausztria
- Medical University of GrazGraz, AusztriaTaking people
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 2025-523478-17-00
- Record updated
- 2026. február 16.
- Original description
The primary aim of this study is to investigate how effective 2 aflibercept 8 mg loading doses lead to a non-active disease.Read full original descriptionShow less
The primary aim of this study is to investigate how effective 2 aflibercept 8 mg loading doses lead to a non-active disease.
Inclusion: Patients must be ≥50 years old on day 1; All patients must be nAMD (neovascular age-related macular degeneration) treatment-naïve on the study eye; All AMDs must be type 1 or 2; Choroidal neovascularization lesion size have to be of nine or fewer disc areas; For each participant, one eye will be chosen as the study eye. Should eligibility apply to both eyes, the one with the lower BCVA during the screening will be selected; The diagnosis must be confirmed with fluorescein and/or indocyanine green angiography; The BCVA should be between 78 - 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at day 1.
Exclusion: Any cataract surgery within 3 months before day 1 or already scheduled during the study period on the study eye; Any other intraocular surgery on the study eye (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant); Subjects who receive any intraocular surgery during the study period on the study eye; Current chemotherapy; >6 diopters of myopia on the study eye (For patients who have undergone previous refractive or cataract surgery, the preoperative refractive error should not have exceeded −6 diopters of myopia); Known intolerance/hypersensitivity to aflibercept 8 mg; Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid (retinal detachment, diabetic maculopathy, epiretinal membrane with traction, central serous chorioretinopathy) on the study eye; Participation in another clinical trial during the last 4 weeks; Polypoidal choroidal vasculopathy (PCV) or type 3 AMD confirmed by fluorescein and/or indocyanine green angiography on the study eye; Simultaneous participation in another clinical trial; Pregnancy or breast-feeding; Retinal pigment epithelium (RPE) tear involving the macula on the study eye on day 1.