Identifying Progression of Retinal Disease in Eyes With NPDR in Diabetes Type 2 Using Non-invasive Procedures

Conditions

Non Proliferative Diabetic Retinopathy, Type 2 Diabetes

Brief summary

The purpose of this study is to identify eyes that show worsening and disease progression (progressor phenotypes).

Detailed description

To identify progressors in retinal vascular disease and central retinal edema in type 2 diabetic patients with early NPDR, based on retinal disease progression from baseline to the 12-month visit, assessed by the following biomarkers: * Microaneurysms turnover (MA formation rate over or equal to 2, i.e. number of new MA from baseline to the 12-month visit) computed from color fundus photographs using the RetmarkerDR software; and * Retinal thickness increase in eyes with retinal thickening (Increase in retinal thickness above normal range) in the central subfield, the inner ring and/or the outer ring Constantly Present, Present or Absent (as measured by OCT and considering the macula thickness normative data.

Cunha-Vaz J, Santos T, Ribeiro L, Alves D, Marques I, Goldberg M.

2016-12-0124 citations

10.1167/iovs.16-19999

Characterization of Retinal Disease Progression in a 1-Year Longitudinal Study of Eyes With Mild Nonproliferative Retinopathy in Diabetes Type 2

Luísa Ribeiro, Francesco Bandello, Amparo Návea, Stela Vujosevic, Monica Varano et al. (23 authors)

Investigative Ophthalmology & Visual Science2015-08-3124 citations

10.1167/iovs.15-16708

Retinal layer location of increased retinal thickness in eyes with subclinical and clinical macular edema in diabetes type 2.

Bandello F, Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jürgens I, Smets RM, Coriat C, Wiedemann P, Ágoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Cunha-Vaz J, EVICR.net.

2015-08-2138 citations

10.1159/000438792

One-year progression of diabetic subclinical macular edema in eyes with mild nonproliferative diabetic retinopathy: location of the increase in retinal thickness.

Tejerina AN, Vujosevic S, Varano M, Egan C, Sivaprasad S, Menon G, Massin P, Verbraak FD, Lund-Andersen H, Martinez JP, Jurgens I, Smets E, Coriat C, Wiedemann P, Ágoas V, Querques G, Holz FG, Nunes S, Alves D, Neves C, Santos T, Ribeiro L, Bandello F, Cunha-Vaz J, for EVICR.net.

2015-08-2111 citations

10.1159/000438793

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

No

Inclusion criteria

1. Diabetes type 2 according to 1985 WHO criteria 2. Age between 35 and 75 years 3. Mild non-proliferative diabetic retinopathy (levels 20 or 35, based on the ETDRS criteria) - 7 fields color fundus photography 4. Presence of at least 1 microaneurysm in the central 3000 micr. in diameter area (corresponding to 2 DA) - Field 2 5. Best Corrected Visual Acuity \>= 75 letters (\>= 20 /32) 6. Refraction with a spherical equivalent less than 5 Dp 7. Informed consent

Exclusion criteria

1. Cataract or other eye disease that may interfere with fundus examinations 2. Glaucoma 3. Any eye surgery within a period of 6-months 4. Other retinal vascular disease 5. Previous laser therapy 6. Dilatation of the pupil \< 5 mm

Design outcomes

Primary

Measure	Time frame	Description
Identify progressors	12 months	To identify progressors in retinal vascular disease and central retinal edema, the following 2 biomarkers will be considered: the MA formation rate (biomarker for the progression of retinal vascular disease) and the presence of retinal thickening in the central subfield and/or the inner ring (biomarker for the presence of retinal edema).

Secondary

Measure	Time frame	Description
Identify correlations between progressors and study outcomes.	12 months	To identify correlations between progressors and the different study outcomes. To explore the parameters, and to identify highly predictive outcomes.

Countries

Portugal

Outcome results