Characterization of Retinal Vascular Disease in Eyes With Mild to Moderate NPDR in Diabetes Type 2
CORDIS
1 other identifier
interventional
141
1 country
1
Brief Summary
Characterization of Retinal vascular disease in eyes with mild to moderate NPDR in Diabetes type 2, using novel non-invasive Imaging methods, in a longitudinal, prospective and interventional clinical Study with 2 years of duration (CORDIS).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2018
Longer than P75 for not_applicable
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 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 5, 2018
CompletedStudy Start
First participant enrolled
October 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 29, 2022
CompletedOctober 12, 2022
October 1, 2022
1.2 years
September 28, 2018
October 11, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Development of CIME or PDR
Characterization of retinal microvascular changes occurring in eyes with mild to moderate NPDR
24 months
Capillary closure in the superficial and deep retinal vascular layers
Capillary closure in the superficial and deep retinal vascular layers by vessel density calculation, quantified by OCTA software (Angioplex, Zeiss);
24 months
LOR ratios
LOR ratios obtained with OCT-L analysis in the full retina and layer by layer.
24 months
Secondary Outcomes (2)
Microaneurysms turnover
24 months
Retinal Thickness
24 months
Study Arms (1)
• Laboratory tests
OTHER• Laboratory tests (HbA1C levels and lipids)
Interventions
Eligibility Criteria
You may not qualify if:
- Cataract or other eye disease that may interfere with fundus examinations.
- Glaucoma.
- Any eye surgery within a period of 6-months before the screening visit date.
- Other retinal vascular disease.
- Previous laser or intravitreal injection treatment.
- Dilatation of the pupil \< 5 mm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIBILI- Association for Biomedical Research and Inovation on Light and Image.
Coimbra, 3000-548, Portugal
Related Publications (1)
Marques IP, Ribeiro ML, Santos T, Reste-Ferreira D, Mendes L, Martinho AC, Santos AR, Figueira J, Lobo C, Cunha-Vaz J. Patterns of Progression of Nonproliferative Diabetic Retinopathy Using Non-Invasive Imaging. Transl Vis Sci Technol. 2024 May 1;13(5):22. doi: 10.1167/tvst.13.5.22.
PMID: 38780953DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2018
First Posted
October 5, 2018
Study Start
October 30, 2018
Primary Completion
December 31, 2019
Study Completion
June 29, 2022
Last Updated
October 12, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share