Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07515521

Acronym

EVITE-AMD

Enrollment

150

Registered

2026-04-07

Start date

2026-02-15

Completion date

2028-12-15

Last updated

2026-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age - Related Macular Degeneration (AMD)

Keywords

AMD

Brief 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.

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Rod-Intercept Time	18 months	Change from baseline

Countries

Germany

Contacts

CONTACTMaximilian Pfau, MD, FEBO

maximilian.pfau@ukbonn.de+49 228 287 15505

Outcome results