NCT07434713

EarLy Treatment Response in nEoVascular Macular Degeneration With Eylea 8mg: ELEV8 A Prospective Observational Open Label Study Investigating the Fluid Dynamics During Early Response to Aflibercept 8mg in Patients With Exudative Age-related Macular Degeneration (AMD).

EarLy Treatment Response in nEoVascular Macular Degeneration With Eylea 8mg: ELEV8

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This prospective, observational, open-label study evaluates early treatment response to intravitreal aflibercept 8 mg in patients with exudative age-related macular degeneration. Retinal fluid dynamics assessed by optical coherence tomography and changes in best-corrected visual acuity two months after baseline are analyzed to characterize early treatment outcomes.

Detailed description

This prospective, observational, open-label study investigates early anatomical and functional responses to intravitreal aflibercept 8 mg in patients with exudative age-related macular degeneration (AMD). The primary focus is on retinal fluid dynamics during the initial treatment phase, assessed by macular optical coherence tomography (OCT). Changes in intraretinal fluid, subretinal fluid, and sub-retinal pigment epithelium (sub-RPE) fluid levels are evaluated over the first two months of treatment. In addition, the frequency of detection of hyperreflective retinal foci (HRF) and complete retinal pigment epithelium and outer retinal atrophy (cRORA) on OCT scans is assessed during this period. Functional outcomes are evaluated by changes in best-corrected visual acuity (BCVA), measured using ETDRS charts, two months after baseline. Furthermore, the proportion of patients without signs of disease activity at two months is determined. Early anatomical and functional responses observed during the first two months are analyzed to explore their potential value in predicting treatment demand over the first year of therapy.

Conditions

• Age-Related Macular Degeneration (AMD)

Interventions

Type	Name	Description
DRUG	treatment with Aflibercept 8mg (Eylea)	intravitreal injection of 8mg aflibercept

Timeline

• Start date: 2025-07-14
• Primary completion: 2026-03-27
• Completion: 2026-03-27
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated drug study