Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMaximilian Pfau
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Healthy volunteers and patients with early or intermediate AMD.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
150 Participants
are grouped into 3 trial groupsGroup A: Aging (healthy volunteers)
Group B: Early AMD
Group C: Intermediate AMD
Trial outcomes
Primary outcomes
1
Rod-Intercept Time
Change from baseline
Time frame
18 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Maximilian Pfau
Lead sponsor
University Hospital, Bonn
Sponsor institution
Source ClinicalTrials.gov