NCT02422160

Brief Summary

The investigators have developed an image analysis method that can predict the likelihood that a patient with age related macular degeneration (AMD) will progress within 1 year, based on computerized analysis of optical coherence tomography (OCT) images that are routinely acquired in clinical practice on each patient visit to the ophthalmologist. The investigators' goal is to evaluate whether this method will improve the ability to detect AMD earlier and improve visual outcomes in AMD patients by assigning patient risk categories and having patients come back for follow up based on those categories.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

6.7 years

First QC Date

April 16, 2015

Last Update Submit

May 16, 2022

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Visual Acuity

    Two Years

Interventions

No interventions are plannedOTHER

No interventions are planned

Eligibility Criteria

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

Patients with non-exudative age-related macular degneration

You may qualify if:

  • Non-exudative age-related macular degeneration

You may not qualify if:

  • Exudative age-related macular degeneration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Byers Eye Institute at Stanford

Palo Alto, California, 94303, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

April 16, 2015

First Posted

April 21, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

US(1)