Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Age - Related Macular Degeneration (AMD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
Age-related macular degeneration (AMD) is a major cause of visual impairment. Treatments currently exist only for late-stage disease, while early and intermediate AMD lack validated functional endpoints suitable for treatment trials. This study will validate fundus-tracked dark adaptometry by determining its diagnostic accuracy, within-visit and between-visit repeatability, and longitudinal sensitivity to change. In addition, multimodal retinal imaging, blood-based biomarkers, metabolomics, proteomics, and AMD-related genetic variants will be assessed for their ability to predict or explain delayed dark adaptation. Healthy volunteers will undergo 2 visits (baseline and month 2); participants with early or intermediate AMD will undergo 3 visits (baseline, month 2, and month 18).
Primary outcome measures
- Rod-Intercept Time [Time frame: 18 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Ophthalmology, University Hospital Bonn — Bonn
Publications
- Ansari G, Oertli J, Machler L, Lipsky T, Jeffrey BG, Cukras CA, Feltgen N, Klaver CCW, Pfau K, Pfau M. Parafoveal Dark Adaptation in Early and Intermediate Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2026 May 1;67(5):74. doi: 10.1167/iovs.67.5.74. PMID 42212881
- Oertli JM, Pfau K, Scholl HPN, Jeffrey BG, Pfau M. Establishing Fully-Automated Fundus-Controlled Dark Adaptometry: A Validation and Retest-Reliability Study. Transl Vis Sci Technol. 2023 Dec 1;12(12):18. doi: 10.1167/tvst.12.12.18. PMID 38112496
Identifiers
NCT: NCT07515521 · EVITE-AMD