NCT02876744

Brief Summary

The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The accuracy of the analysis of the vascularization of retinal layers of the posterior pole of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there are areas of macular ischemia in a patient. However, current technical limitations (small field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole of the fundus. This study seeks to demonstrate whether there is a link between macular ischemia detected by the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration 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

First Submitted

Initial submission to the registry

August 19, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

April 4, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

3 years

First QC Date

August 19, 2016

Last Update Submit

January 13, 2021

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Detection and measure of ischemic territories in central and peripheral retina

    immediate

Interventions

ophthalmologic examinationOTHER

ophthalmologic examination including optical coherent tomography with angiography module

Eligibility Criteria

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

Patients with diabetes, requiring follow-up with fluorescein angiography.

You may qualify if:

  • diabetes type I or type II
  • follow-up with fluorescein angiography

You may not qualify if:

  • known allergy to fluorescein
  • contra-indication to fluorescein angiography
  • pregnant or breast-feeding patient
  • technical impossibility to analyse retinal ischemic areas on fluorescein angiography or OCT-A.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Opthalmologique A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Martine MAUGET FAYSSE, MD

    Fondation ophtalmologique de Rothschild

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 24, 2016

Study Start

April 4, 2017

Primary Completion

April 13, 2020

Study Completion

December 15, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)