NCT04537143

Brief Summary

To study qualitatively and quantitatively the Imaging Biomarkers (IBs) on Multi-modal Imaging with Novel technologies (MINT), in order to understand their role in prediction of the Age-related Macular Degeneration (AMD) progression in eyes with and without treatment. The understanding of IBs will allow early detection of AMD, prediction of its evolution, and guidance for the best options for stratified/individualized treatment of AMD.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2021

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

September 28, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

August 28, 2020

Last Update Submit

September 24, 2020

Conditions

AMD

Outcome Measures

Primary Outcomes (2)

  • ONH diameter

    1-2 year FU

  • area of MNV

    1-2 year FU

Study Arms (2)

Control

Non-AMD eyes

AMD

AMD eyes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Half control, half AMD eyes

You may qualify if:

  • being male or female
  • at least 18 years of age
  • varied ethnic backgrounds (different ethnic groups have different structures of eye anatomy and we must be able to make ethnic subgroups to account for these differences)

You may not qualify if:

  • vulnerable patients
  • patients under 18
  • pregnant (we exclude pregnant women because pregnancy often can alter eye anatomy)
  • economically and educationally disadvantaged
  • decision impaired
  • homeless people.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Program Manager - Research

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 3, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

September 28, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share