NCT07515521Recruiting
Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
Source: ClinicalTrials.gov · Last updated 7 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 150 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 15 Feb 2026
- Primary completion date
- 15 Dec 2028
- Lead sponsor
- Maximilian Pfau
- Diseases
- Macular degeneration
- NCT number
- NCT07515521
What you commit to
- Study type: Observational
- Planned participants: 150
- From 15 Feb 2026 to the primary completion date, 15 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Lab values
- Hypersensitivity to indocyanine green or sodium iodide, iodine allergy, or hyperthyroidism.
Other
- Claustrophobia relevant to dark-adaptation procedures.
- Known pregnancy.
- Inability to comply with study procedures or insufficient language skills in the study language.
- Inability to provide informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Ophthalmology, University Hospital Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.