Enhanced vision and imaging tests to enable treatments for early and intermediate AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This monocentric prospective longitudinal observational project will validate fundus-tracked dark adaptometry as a functional endpoint for early and intermediate age-related macular degeneration (AMD). It will establish normative cone- and rod-mediated dark adaptation parameters in healthy volunteers, test within-visit and between-visit repeatability, and measure sensitivity to change over 18 months in AMD participants. The study will compare dark-adaptation results to AMD stage and structural progression and will explore multimodal retinal imaging, blood biomarkers, metabolomics, proteomics, and AMD-related genetic variants as determinants of impaired dark adaptation. Healthy volunteers undergo two visits (baseline and month 2) while participants with early or intermediate AMD undergo three visits (baseline, month 2, and month 18).

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Ophthalmology, University Hospital Bonn
  Bonn, Germany Recruiting

Study contacts

• Study coordinator: Maximilian Pfau, MD, FEBO
• Email: maximilian.pfau@ukbonn.de
• Phone: +49 228 287 15505

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.