Two initial aflibercept 8 mg loading doses in treatment-naive neovascular AMD

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Graz

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

3 Mar 2026 → ongoing

Decision date (initial)

2026-02-16

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

The primary aim of this study is to investigate how effective 2 aflibercept 8 mg loading doses lead to a non-active disease.

Secondary objectives 1

1. Secondary aims include finding characteristics that predict disease activity and investigating the effects of two initial loading doses of aflibercept 8 mg on the time of recurrence of disease activity and functional development.

Conditions and MedDRA coding

Neovascular age-related macular degeneration

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Patients must be ≥50 years old on day 1.
2. All patients must be nAMD (neovascular age-related macular degeneration) treatment-naïve on the study eye.
3. All AMDs must be type 1 or 2.
4. Choroidal neovascularization lesion size have to be of nine or fewer disc areas.
5. 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.
6. The diagnosis must be confirmed with fluorescein and/or indocyanine green angiography.
7. The BCVA should be between 78 - 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at day 1.

Exclusion criteria 12

1. Participation in another clinical trial during the last 4 weeks.
2. Simultaneous participation in another clinical trial.
3. Subjects who receive any intraocular surgery during the study period on the study eye.
4. Pregnancy or breast-feeding.
5. Current chemotherapy.
6. Known intolerance/hypersensitivity to aflibercept 8 mg.
7. 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.
8. Retinal pigment epithelium (RPE) tear involving the macula on the study eye on day 1.
9. >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).
10. Any cataract surgery within 3 months before day 1 or already scheduled during the study period on the study eye.
11. Any other intraocular surgery on the study eye (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant).
12. Polypoidal choroidal vasculopathy (PCV) or type 3 AMD confirmed by fluorescein and/or indocyanine green angiography on the study eye.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients without disease activity at week 8.

Secondary endpoints 4

1. Proportion of patients with a 4, 6, 8, 10, 12, 14 or 16 week treatment interval between the 2nd aflibercept 8 mg loading dose and the 3rd aflibercept 8 mg injection
2. Change in best corrected visual acuity from baseline to week 4 and 8.
3. Change in central subfield thickness and macular fluid volume from baseline to week 4 and 8.
4. Characteristics/measurements in optical coherence tomography (OCT), optical coherence tomography angiography (OCTA), angiography and best corrected visual acuity (BCVA) assessment, which can predict active/non-active disease.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Graz

Sponsor organisation

Medical University Of Graz

Address

Neue Stiftingtalstrasse 6

City

Graz

Postcode

8010

Country

Austria

Scientific contact point

Organisation

Medical University Of Graz

Contact name

Investigator

Public contact point

Organisation

Medical University Of Graz

Contact name

Investigator

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications