Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD (NCT07515521) | Clinical Trial Compass
RecruitingNot Applicable
Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
Germany150 participantsStarted 2026-02-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.