Enhanced vision and imaging tests to enable treatments for early and intermediate AMD
Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
We will see if a fundus-tracked dark adaptometry test can reliably detect and track vision changes in people with early or intermediate AMD and in healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bonn Academic / other |
| Locations | 1 site (Bonn) |
| Trial ID | NCT07515521 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates are adults able to understand German or English: healthy volunteers aged 18+ without drusen, or adults aged 55+ with early (drusen 63–125 µm without pigmentary changes) or intermediate AMD (drusen >125 µm and/or pigmentary changes).
Not a fit: People with late-stage AMD, other ocular diseases affecting visual testing, recent ocular surgery (except cataract surgery, YAG capsulotomy, or laser retinopexy), pregnancy, claustrophobia preventing dark-adaptation testing, or iodine/indocyanine green allergies are not suitable and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a reliable functional endpoint to enable treatment trials and earlier interventions for people with early or intermediate AMD.
How similar studies have performed: Prior work has shown delayed dark adaptation can predict AMD progression, but fundus-tracked dark adaptometry is a newer approach that still requires longitudinal validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bonn
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.