NCT04650165

Brief Summary

To characterize both functionally and morphologically initial Diabetic Retinopathy (DR) stages and their progression over a period of 10 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

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

November 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
Last Updated

October 16, 2024

Status Verified

October 1, 2024

Enrollment Period

2.8 years

First QC Date

November 25, 2020

Last Update Submit

October 15, 2024

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

  • Phenotypic classification of DR in a 5-year period

    Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)

    5 years

  • DR severity level

    Early Treatment Diabetic Retinopathy Study Research Group, grading (7 fields-CFP)

    5 years

Secondary Outcomes (7)

  • Choroidal thickness analysis

    5 years

  • Retinal thickness analysis

    5 years

  • Ellipsoid zone analysis

    5 years

  • SD- OCT- Angiography analysis

    5 years

  • OCT-Leakage analysis

    5 years

  • +2 more secondary outcomes

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Male and female subjects older than 50 years-old with type 2 Diabetes mellitus and no Diabetic Retinopathy or mild Non-Proliferative Diabetic Retinopathy who have participated in the PROGRESS study (NCT03010397).

You may qualify if:

  • Subjects who have participated in the PROGRESS study;
  • Subjects capable of understanding the information about the study and to give their informed consent to enter the study.
  • Subjects willing and able to comply with the study

You may not qualify if:

  • \- Inadequate ocular media and/ or pupil dilatation that interfere with fundus examinations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIBILI - Association for Innovation and Biomedical Research on Light and Image

Coimbra, 3000-548, Portugal

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Inês P Marques, MD

    AIBILI - Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 2, 2020

Study Start

June 1, 2021

Primary Completion

March 27, 2024

Study Completion

March 27, 2024

Last Updated

October 16, 2024

Record last verified: 2024-10

Locations

PT(1)