Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes (PROGRESS)

March 23, 2020 updated by: Association for Innovation and Biomedical Research on Light and Image

PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes

Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes (PROGRESS)

Study Overview

Status

Completed

Conditions

Detailed Description

The global aim of this study is to improve the current knowledge of diabetic retinopathy (DR) progression. We aim to characterize both functionally and morphologically initial DR stages and to identify patients at risk of progression to centre involving macular oedema (CME) and/or proliferative diabetic retinopathy (PDR). We want to identify imaging patterns and characteristics that might be used as prognostic biomarkers for DR progression.

For this, ischemia and blood-retinal barrier alteration will be assessed using non-invasive retinal imaging methodologies. SD-OCT with layer-by-layer segmentation will be performed. Furthermore, a state-of-the-art methodology with OCT-Angiography will be used for identification of areas of capillary drop-out and leakage areas will be identified on SD-OCT without the need of a dye injection. In a subgroup of patients we will study neurodegeneration patterns using multifocal ERG examination.

Study Type

Observational

Enrollment (Anticipated)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Coimbra, Portugal, 3000-548
        • Aibili-Cec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any patients followed under the normal clinical practice at AIBILI Clinical Trial Centre.

- Type 2 diabetes mellitus according to 1985 WHO criteria

Description

Inclusion Criteria:

  • Type 2 diabetes mellitus according to 1985 WHO criteria
  • Aged between 35 years and 80 at baseline in the retrospective period
  • NPDR level < 20 (MA absent) or Mild NPDR (levels 20 to 35, based on ETDRS criteria- 7 fields CFP) at baseline
  • BCVA ≥ 75 letters (≥ 20/32) at baseline (ETDRS charts)
  • Informed Consent

Exclusion Criteria:

  • Inadequate ocular media and/ or pupil dilatation that interfere with fundus examinations
  • HbA1C > 10 % at the Screening or previous 6 months in the previous prospective study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phenotypic classification of DR in a 5-year period
Time Frame: 5 years
Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DR severity level
Time Frame: 5 years
ETDRS grading
5 years
Retinal thickness analysis
Time Frame: 5 years
Retinal thickness (RT) in central subfield, inner and outer rings, assessed by SD-OCT and using layer-by-layer segmentation
5 years
Ellipsoid zone analysis
Time Frame: 5 years
Degree of integrity of the ellipsoid zone, assessed by SD-OCT
5 years
Choroidal thickness analysis
Time Frame: 5 years
Choroidal thickness assessed by Enhanced Depth Imaging (EDI) SD-OCT
5 years
SD- OCT- Angiography analysis
Time Frame: 5 years
Vessel analysis, assessed by SD-OCT OCT-Angiography
5 years
OCT-Leakage analysis
Time Frame: 5 years
LOR (low optical reflectivity) ratio in central subfield, inner and outer ring for assessment of BRB breakdown, assessed by OCT-Leakage
5 years
Retinal thickness quantification
Time Frame: 5 years
Retinal nerve fiber layer thickness (RNFL) and ganglion cells layer (GCL) + inner plexiform layer thickness (IPL) thickness, assessed by layer-by-layer SD-OCT
5 years
mfERG assessement
Time Frame: 5 years
P1 implicit time and P1 amplitude by ring
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

January 11, 2017

Study Completion (Actual)

March 6, 2019

Study Registration Dates

First Submitted

September 19, 2016

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 5, 2017

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 23, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPM-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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