Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
PROGRESS
PROGRESS - Progression of Diabetic Retinopathy. Identification of Signs and Surrogate Outcomes
1 other identifier
observational
212
1 country
1
Brief Summary
Progression of Diabetic Retinopathy. Identification of Signs and Surrogate outcomes (PROGRESS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2016
Typical duration for all trials
1 active site
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
September 19, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2019
CompletedMarch 24, 2020
March 1, 2020
1 month
September 19, 2016
March 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Phenotypic classification of DR in a 5-year period
Presence CME (Central Macular Edema) or PDR (Proliferative Diabetic Retinopathy)
5 years
Secondary Outcomes (8)
DR severity level
5 years
Retinal thickness analysis
5 years
Ellipsoid zone analysis
5 years
Choroidal thickness analysis
5 years
SD- OCT- Angiography analysis
5 years
- +3 more secondary outcomes
Eligibility Criteria
Any patients followed under the normal clinical practice at AIBILI Clinical Trial Centre. \- Type 2 diabetes mellitus according to 1985 WHO criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aibili-Cec
Coimbra, 3000-548, Portugal
Related Publications (2)
Martinho AC, Marques IP, Messias AL, Santos T, Madeira MH, Sousa DC, Lobo C, Cunha-Vaz J. Ocular and Systemic Risk Markers for Development of Macular Edema and Proliferative Retinopathy in Type 2 Diabetes: A 5-Year Longitudinal Study. Diabetes Care. 2021 Jan;44(1):e12-e14. doi: 10.2337/dc20-1125. Epub 2020 Nov 6. No abstract available.
PMID: 33158947DERIVEDMarques IP, Alves D, Santos T, Mendes L, Santos AR, Lobo C, Durbin M, Cunha-Vaz J. Multimodal Imaging of the Initial Stages of Diabetic Retinopathy: Different Disease Pathways in Different Patients. Diabetes. 2019 Mar;68(3):648-653. doi: 10.2337/db18-1077. Epub 2018 Dec 6.
PMID: 30523027DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
September 19, 2016
First Posted
January 5, 2017
Study Start
December 1, 2016
Primary Completion
January 11, 2017
Study Completion
March 6, 2019
Last Updated
March 24, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will share