2025-523478-17-00RecruitingPhase 4
Two initial aflibercept 8 mg loading doses in treatment-naive neovascular AMD
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Feb 2026
Brief summary (registry, in English)
The primary aim of this study is to investigate how effective 2 aflibercept 8 mg loading doses lead to a non-active disease.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 17 Nov 2025
- Start date
- 3 Mar 2026
- Lead sponsor
- Medical University Of Graz
- Diseases
- Macular degeneration
- EU CT number
- 2025-523478-17-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 50
- 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.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 or older with neovascular age-related macular degeneration (wet AMD) who have never been treated for it in the study eye.
- Age
- 50 years or older on day 1.
- Sex
- All sexes can join.
- Disease stage
- Neovascular AMD of type 1 or 2. The choroidal neovascularization lesion must be nine or fewer disc areas. The diagnosis must be confirmed by fluorescein and/or indocyanine green angiography. Vision (BCVA) must be between 78 and 24 ETDRS letters on day 1.
- Earlier treatment
- The study eye must not have had any treatment for neovascular AMD before.
Main reasons for not taking part
- Polypoidal choroidal vasculopathy (PCV) or type 3 AMD in the study eye
- Cataract surgery within 3 months before day 1 or planned during the study, or any other eye surgery in the study eye
- Other eye disease in the study eye that affects vision or causes fluid, such as retinal detachment or diabetic maculopathy
- Pregnancy or breast-feeding, or current chemotherapy
- Known allergy or intolerance to aflibercept 8 mg
Read by machine on 9 Nov 2026.
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
- 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).
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
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 | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.