(22578) An open-label, non-randomized, multi-center, phase 4 pharmacokinetic study to evaluate the systemic exposure after bilateral intravitreal administration of high dose (8 mg) aflibercept in adults with diabetic macular edema or neovascular age-related macular degeneration

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511665-11-00

Acronym

22578

Enrollment

Registered

2024-08-19

Start date

2024-08-29

Completion date

2025-10-14

Last updated

2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic macular edema (DME), Neovascular age-related macular degeneration (nAMD)

Brief summary

Maximum observed concentration (Cmax) of free aflibercept

Interventions

DRUGEylea 114.3 mg/ml solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Maximum observed concentration (Cmax) of free aflibercept	—

Countries

Czechia, Hungary, Slovakia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026