Age - Related Macular Degeneration (AMD)EVITE-AMDNCT07515521
Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
An observational study of Age - Related Macular Degeneration (AMD), run by Maximilian Pfau at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age - Related Macular Degeneration (AMD)
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2026to 15 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers and patients with early or intermediate AMD.
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, University Hospital Bonn
Bonn, 53127
Sophia Dithmar, MD, 0228 28715505, Sophia.Dithmar@ukbonn.de
About this study
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.
Read the 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).
- Conditions
- Age - Related Macular Degeneration (AMD)
- Keywords
- AMD
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Aging (healthy volunteers) | Participants with no signs of AMD | |
| Early AMD | Participants with early AMD | |
| Intermediate AMD | Participants with intermediate AMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rod-Intercept Time
Change from baseline
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start15 Feb 2026
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age - Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maximilian Pfau
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maximilian Pfau, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515521
- Sponsor's protocol ID
- EVITE-AMD
- Acronym
- EVITE-AMD
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon completion of the study, the data will be made publicly available in an open science repository (e.g., Zenodo).
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.
PubMed 42212881Oertli 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.
PubMed 38112496
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Vision and Imaging Tests for Enabling Treatment Trials in Early and Intermediate AMD
- ClinicalTrials.gov ID
- NCT07515521
- Acronym / sponsor ID
- EVITE-AMD / EVITE-AMD
- Conditions
- Age - Related Macular Degeneration (AMD)
- Keywords
- AMD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Maximilian PfauUniversity, hospital or other
- Study start
- 15 Feb 2026 (actual)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aging (healthy volunteers) | – | –Participants with no signs of AMD |
| Early AMD | – | –Participants with early AMD |
| Intermediate AMD | – | –Participants with intermediate AMD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers and patients with early or intermediate AMD.
Key inclusion criteria (11 listed)
- 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.
- No drusen >63 um and no subretinal drusenoid deposits in either eye.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rod-Intercept Time
Time frame: 18 months
Change from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Background: PubMed 42212881Ansari 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.
- Background: PubMed 38112496Oertli 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.
- Research GroupLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Upon completion of the study, the data will be made publicly available in an open science repository (e.g., Zenodo).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age - Related Macular Degeneration (AMD), run by Maximilian Pfau at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maximilian Pfau, MD, FEBO (+49 228 287 15505, maximilian.pfau@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rod-Intercept Time (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07515521, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.