Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD (EVITE-AMD)

March 31, 2026 updated by: Maximilian Pfau
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.

Study Overview

Status

Recruiting

Conditions

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).

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Bonn, Germany, 53127
        • Recruiting
        • Department of Ophthalmology, University Hospital Bonn
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers and patients with early or intermediate AMD.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Aging (healthy volunteers)
Participants with no signs of AMD
Early AMD
Participants with early AMD
Intermediate AMD
Participants with intermediate AMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rod-Intercept Time
Time Frame: 18 months
Change from baseline
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maximilian Pfau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2026

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

December 15, 2028

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVITE-AMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon completion of the study, the data will be made publicly available in an open science repository (e.g., Zenodo).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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