Clinical trial NCT01440660: Phenotypes of Nonproliferative Diabetic Retinopathy in DM 2 Patients Identified by OCT, CFP, RLA and mfERG (DIAMARKER)
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).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type-2 Diabetes
Diabetic Retinopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
Collaborators: name: University of Coimbra
First posted: 2011-09-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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


Eligibility criteria: 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.

Primary outcomes:
measure: Multimodal testing/imaging procedures - Ophthalmological Imaging
timeFrame: 24 months
measure: Multimodal testing/imaging procedures - Ophthalmological Imaging
timeFrame: 24 months
measure: Multimodal testing/imaging procedures - Ophthalmological Imaging
timeFrame: 12 months
measure: Multimodal testing/imaging procedures - Ophthalmological Imaging
timeFrame: 12 months
measure: Multimodal testing/imaging procedures - Psychophysical Testing
timeFrame: 12 months
measure: Multimodal testing/imaging procedures - Barin Imaging
timeFrame: 12 months
measure: Multimodal testing/imaging procedures - Ophthalmological Imaging
timeFrame: 12 months
measure: Multimodal testing/imaging procedures - Brain Imaging
timeFrame: 12 months
Secondary outcomes:
measure: Multimodal testing/ imaging modalities (raw data)
timeFrame: 24 months
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI - Clinical Trials Centre (CEC)
Study officials:
affiliation: Association for Innovation and Biomedical Research on Light and Image
name: José Cunha-Vaz, MD PhD
role: STUDY_CHAIR
affiliation: FMUC
name: Miguel Castelo-Branco, MD PhD
role: STUDY_CHAIR
affiliation: AIBILI - CEC
name: Luísa Ribeiro, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: