Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
Maximilian Pfau
150 participants
Feb 15, 2026
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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.
- 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 Criteria8
- 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.
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Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07515521