NCT06860568

Brief Summary

This study used a retrospective dataset collected by Optina under different study protocols. The target study population will include adults over the age of 50 years, with and without the presence of AMD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 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

December 24, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
Last Updated

March 6, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 28, 2025

Last Update Submit

February 28, 2025

Conditions

Geographic AtrophyHealthy

Outcome Measures

Primary Outcomes (4)

  • Comparison of the total number of Relspec images annotated for GA lesions

    Comparison of the total number of Relspec images annotated for GA lesions of at least 29 pixels or larger with the total number of OCT images with identified GA lesions (cRORA) in the Test Dataset.

    45 days

  • Comparison of the total number of 'high certainty' GA lesions

    Comparison of the total number of 'high certainty' GA lesions (Yellow label) of at least 29 pixels annotated in all Relspec images with the total number of (cRORA) identified in the OCT images in the Test Dataset.

    45 days

  • Comparison of the total number of GA lesions

    Comparison of the total number of GA lesions (Yellow label and Dark Blue label) of at least 29 pixels or larger annotated in all Relspec images with the total number of identified GA lesions (cRORA) in the OCT images in the Test Dataset.

    45 days

  • Evaluation of the Global DICE Score

    Evaluation of the Global DICE Score for annotations of 29 pixels or larger performed by CapeStart compared with the Reference Data.

    45 days

Study Arms (3)

Cohort A

Eyes of patients with a diagnosis of dry AMD with GA lesions

Other: Retrospective Study

Cohort B

Eyes of patients with a diagnosis of AMD without the presence of RPE disruptions

Other: Retrospective Study

Cohort C

Eyes of age-matched healthy patients (no AMD or GA lesions)

Other: Retrospective Study

Interventions

Retrospective StudyOTHER

Retrospective Study This study will use a retrospective Test Dataset of eye scans collected by Optina under different study protocols. MHRC H5 Images collected as part of Optina studies CIP-22-003, CIP-22-004, DOC100463 or RWD-24-011 will be reviewed by an Optina Data Analyst and flagged for potential match to the Target Population. Of the flagged images, 40 will be selected and allocated to the Test Dataset. All selected images must have a matching OCT image for review as part of the Reference Data. The Test Dataset will be documented in the CIP-24-015 data spreadsheet and archived in the CIP-24-015 central files.

Cohort ACohort BCohort C

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will use a retrospective dataset collected by Optina under different study protocols. The target study population will include adults over the age of 50 years, with and without the presence of AMD.

You may qualify if:

  • Study participants over the age of 50 years who consented to participate in Optina studies CIP-22-003, CIP-22-004, DOC100463, or RWD-24-011.
  • MHRC H5 Image Cube has been reviewed by an Optina Analyst and identified as aligned with the Target Population (see Section 5.2).
  • MHRC H5 Image Cube has a corresponding OCT image.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Optina Diagnostics Inc

Montreal, Quebec, H4P 2P5, Canada

Location

MeSH Terms

Conditions

Geographic Atrophy

Interventions

Retrospective Studies

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Case-Control StudiesEpidemiologic StudiesEpidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesCohort StudiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Ramina Nissan, OD

    The Glen Site, McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2025

First Posted

March 6, 2025

Study Start

December 24, 2024

Primary Completion

February 18, 2025

Study Completion

February 18, 2025

Last Updated

March 6, 2025

Record last verified: 2025-02

Locations

CA(1)