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

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).

Inclusion criteria

• Written informed consent.
• All biological sexes and gender identities.
• Age >=18 years for healthy volunteers; age >=55 years for participants with AMD.
• Ability to understand German or English sufficiently for study information and procedures.

Additional Inclusion Criteria by Cohort:

Healthy Volunteers:

• No drusen >63 um and no subretinal drusenoid deposits in either eye.

Early AMD:

• Study eye with drusen >63 um but <125 um and no pigmentary changes.

Intermediate AMD:

• Study eye with drusen >125 um and/or pigmentary changes.

Exclusion criteria

• Claustrophobia relevant to dark-adaptation procedures.
• Hypersensitivity to indocyanine green or sodium iodide, iodine allergy, or hyperthyroidism.
• Known pregnancy.
• Study eye history of ocular surgery other than cataract surgery, YAG capsulotomy, or laser retinopexy.
• Ocular disease in the study eye that could affect visual function testing in the opinion of the investigators.
• Medical conditions or planned operations that could interfere with follow-up.
• Inability to comply with study procedures or insufficient language skills in the study language.
• Inability to provide informed consent.