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

NCT01440660 | Completed

• 1 other identifier: 4C-2011-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type-2 Diabetes; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (8)

• Multimodal testing/imaging procedures - Ophthalmological Imaging

  Retinal thickness measured with OCT;

  24 months

• Multimodal testing/imaging procedures - Ophthalmological Imaging

  MA turnover computed based on CFP.

  24 months

• Multimodal testing/imaging procedures - Ophthalmological Imaging

  Macular area with increased retinal fluorescein leakage based on RLA.

  12 months

• Multimodal testing/imaging procedures - Ophthalmological Imaging

  Implicit time local and ring amplitudes measured with mfERG.

  12 months

• Multimodal testing/imaging procedures - Psychophysical Testing

  Psychophysical tests for speed discrimination, achromatic contrast, and chromatic contrast.

  12 months

• Multimodal testing/imaging procedures - Barin Imaging

  Perfusion change measured with ASL.

  12 months

• Multimodal testing/imaging procedures - Ophthalmological Imaging

  Blood-Brain Barrier alterations assessed contrast agent with Dynamic MR.

  12 months

• Multimodal testing/imaging procedures - Brain Imaging

  Metabolite concentrations assessed with MR Spectroscopy.

  12 months

Secondary Outcomes (1)

• Multimodal testing/ imaging modalities (raw data)

  24 months

Study Arms (2)

Leaking Phenotype

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.

Ischemic Phenotype

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of 20 patients, male and female over 18 years-old, with type-2 diabetes mellitus and NPDR with signs of DR progression (RT increase and/or MA turnover) (according to the inclusion/exclusion criteria).

You may qualify if:

• Age over 18 years-old.
• Diabetes mellitus type 2 according to 1985 WHO criteria.
• Non-proliferative diabetic retinopathy (ETDRS level \<= 35)
• Signs of NPDR progression based on existing clinical information:
• 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
• 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).
• Informed consent.

You may not qualify if:

• Cataract or other eye disease that may interfere with fundus examinations
• Any eye surgery or treatment within a period of 6-months.
• Pregnant or nursing (lactating) women.
• Patients with chronic or severe kidney disease (glomerular filtration rate, GFR \< 30 mL/min/1.73m2).
• Patients with acute kidney injury.
• Patients with known allergic or hypersensitivity reactions to gadolinium, versetamide or any of the inert ingredients.
• Patients around the time of liver transplantation..
• Patients with implants containing metals.

Sponsors & Collaborators

• Association for Innovation and Biomedical Research on Light and Image: lead
• University of Coimbra: collaborator

Study Sites (1)

AIBILI - Clinical Trials Centre (CEC)

Coimbra, 3000-548, Portugal

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• José Cunha-Vaz, MD PhD

  Association for Innovation and Biomedical Research on Light and Image

  STUDY CHAIR

• Miguel Castelo-Branco, MD PhD

  FMUC

  STUDY CHAIR

• Luísa Ribeiro, MD MSc

  AIBILI - CEC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 26, 2011
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 8, 2015

Record last verified: 2015-10

Locations

PT (1)