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

Completed

• Conditions: Type-2 Diabetes; Diabetic Retinopathy

• Registration Number: NCT01440660
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-22
• Study First Submitted QC: 2011-09-23
• Study First Posted: 2011-09-26
• Study Start: 2012-01
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-07
• Last Update Posted: 2015-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multimodal testing/imaging procedures - Brain Imaging	12 months	Metabolite concentrations assessed with MR Spectroscopy.
Multimodal testing/imaging procedures - Ophthalmological Imaging	12 months	Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR.
Multimodal testing/imaging procedures - Psychophysical Testing	12 months	Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.
Multimodal testing/imaging procedures - Barin Imaging	12 months	Perfusion change measured with ASL.

Secondary Outcome Measures

Name	Time	Method
Multimodal testing/ imaging modalities (raw data)	24 months	Raw data obtained from the different modalities (OCT,MA turnover, RLA,mfERG, psychophysical tests, ASL, Dynamic MR and MR Spectroscopy).

Trial Locations

Locations (1)

AIBILI - Clinical Trials Centre (CEC); 🇵🇹 Coimbra, Portugal