Phenotypes of Nonproliferative Diabetic Retinopathy in DM 2 Patients Identified by OCT, CFP, RLA and mfERG (DIAMARKER)

Diabetic Retinopathy Clinical Trial

Official title:

Phenotypes of Nonproliferative Diabetic Retinopathy in Diabetes Type 2 Patients Identified by Optical Coherence Tomography, Colour Fundus Photography, Fluorescein Leakage and Multifocal Electrophysiology (DIAMARKER Project: Genetic Susceptibility for Multi-systemic Complications in Diabetes Type-2: New Biomarkers for Diagnostic and Therapeutic Monitoring).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440660
• Other study ID #: 4C-2011-01
• Status: Completed
• Phase: N/A
• First received: September 22, 2011
• Last updated: October 7, 2015
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Association for Innovation and Biomedical Research on Light and Image
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Health Ethic Committee
• Study type: Observational

Clinical Trial Summary

To characterise phenotypes of Non Proliferative Diabetic Retinopathy (NPDR) progression using multimodal testing/imaging procedures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age over 18 years-old.

2. Diabetes mellitus type 2 according to 1985 WHO criteria.

3. Non-proliferative diabetic retinopathy (ETDRS level <= 35)

4. Signs of NPDR progression based on existing clinical information:

1. Retinal thickness (RT) increase (increase in RT above normal range as measured by OCT, considering the macular thickness normative data) in the central subfield, the inner ring and/or the outer ring (leaking phenotype); OR

2. Neovascular disease activity as shown by microaneurysms (MA) turnover (MA formation rate >= 2, i.e. number of new MA per year) computed from CFP using the RetmarkerDR software (ischemic phenotype).

5. Informed consent.

Exclusion Criteria:

1. Cataract or other eye disease that may interfere with fundus examinations

2. Any eye surgery or treatment within a period of 6-months.

3. Pregnant or nursing (lactating) women.

4. Patients with chronic or severe kidney disease (glomerular filtration rate, GFR < 30 mL/min/1.73m2).

5. Patients with acute kidney injury.

6. Patients with known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.

7. Patients around the time of liver transplantation..

8. Patients with implants containing metals.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases
• Type-2 Diabetes

Locations

Country	Name	City	State
Portugal	AIBILI - Clinical Trials Centre (CEC)	Coimbra

Sponsors (2)

Lead Sponsor	Collaborator
Association for Innovation and Biomedical Research on Light and Image	University of Coimbra

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multimodal testing/imaging procedures - Ophthalmological Imaging	Retinal thickness measured with OCT;	24 months	Yes
Primary	Multimodal testing/imaging procedures - Ophthalmological Imaging	MA turnover computed based on CFP.	24 months	Yes
Primary	Multimodal testing/imaging procedures - Ophthalmological Imaging	Macular area with increased retinal fluorescein leakage based on RLA.	12 months	Yes
Primary	Multimodal testing/imaging procedures - Ophthalmological Imaging	Implicit time local and ring amplitudes measured with mfERG.	12 months	Yes
Primary	Multimodal testing/imaging procedures - Psychophysical Testing	Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.	12 months	Yes
Primary	Multimodal testing/imaging procedures - Barin Imaging	Perfusion change measured with ASL.	12 months	Yes
Primary	Multimodal testing/imaging procedures - Ophthalmological Imaging	Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR.	12 months	Yes
Primary	Multimodal testing/imaging procedures - Brain Imaging	Metabolite concentrations assessed with MR Spectroscopy.	12 months	Yes
Secondary	Multimodal testing/ imaging modalities (raw data)	Raw data obtained from the different modalities (OCT,MA turnover, RLA,mfERG, psychophysical tests, ASL, Dynamic MR and MR Spectroscopy).	24 months	No