NCT07515521

Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Maximilian Pfau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This monocentric prospective longitudinal observational study will validate fundus-tracked dark adaptometry as an endpoint for future treatment trials in early and intermediate age-related macular degeneration (AMD). The study will characterize normative cone- and rod-mediated dark adaptation parameters in healthy volunteers, assess test-retest reliability, quantify sensitivity to change over time, evaluate diagnostic and prognostic validity against AMD stage and structural progression, and investigate imaging-, biomarker-, and genetics-based determinants of impaired dark adaptation.

Detailed description

Age-related macular degeneration (AMD) is a major cause of visual impairment. Treatments currently exist only for late-stage disease, while early and intermediate AMD lack validated functional endpoints suitable for treatment trials. This study will validate fundus-tracked dark adaptometry by determining its diagnostic accuracy, within-visit and between-visit repeatability, and longitudinal sensitivity to change. In addition, multimodal retinal imaging, blood-based biomarkers, metabolomics, proteomics, and AMD-related genetic variants will be assessed for their ability to predict or explain delayed dark adaptation. Healthy volunteers will undergo 2 visits (baseline and month 2); participants with early or intermediate AMD will undergo 3 visits (baseline, month 2, and month 18).

Conditions

• Age - Related Macular Degeneration (AMD)

Timeline

• Start date: 2026-02-15
• Primary completion: 2028-12-15
• Completion: 2028-12-15
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: Germany