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Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5698-705. doi: 10.1167/iovs.15-16708.

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

Author information

1
Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal.
2
Department of Ophthalmology, University Vita Salute-Scientific Institute of San Raffael, Milan, Italy.
3
Fundación para la Investigacion Biomedica y Sanitaria, FISABIO-OFTALMOLOGIA, Valencia, Spain.
4
Centre for Clinical Trials, Department of Ophthalmology, University of Padova, Padova, Italy.
5
G.B. Bietti Eye Foundation-IRCCS, Rome, Italy.
6
Clinical Trials Unit, Moorfields Eye Hospital, NHS Foundation Trust, London, United Kingdom.
7
Laser and Retinal Research Unit, King's Health Partners, London, United Kingdom.
8
Ophthalmology Clinical Trials Unit, Frimley Park Hospital Foundation Trust, Frimley, United Kingdom.
9
Department of Ophthalmology, Lariboisière Hospital, Paris, France.
10
Department of Ophthalmology, Academic Medical Center, Amsterdam, The Netherlands.
11
Department of Ophthalmology, Glostrup Hospital, Copenhagen University, Glostrup, Denmark.
12
Rotterdam Eye Hospital, Rotterdam, The Netherlands.
13
Institut Català de Retina (ICR), Barcelona, Spain.
14
Antwerp University Hospital, Department of Ophthalmology, Antwerp, Belgium.
15
Centre d'Investigation Clinique, Centre National d'Ophtalmologie des Quinze-Vingts, Paris, France.
16
University Eye Hospital Leipzig, Leipzig, Germany.
17
Instituto de Oftalmologia Dr. Gama Pinto, Lisboa, Portugal.
18
Centre Hospitalier Intercommunal de Creteil, University Paris-Est Creteil, Creteil, France.
19
Department of Ophthalmology, University of Bonn, Bonn, Germany.

Abstract

PURPOSE:

To identify eyes of patients with diabetes type 2 that show progression of retinal disease within a 1-year period using noninvasive techniques.

METHODS:

Three hundred seventy-four type 2 diabetic patients with mild nonproliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] level 20 or 35) were included in a 12-month prospective observational study to identify retinopathy progression. Four visits were scheduled at 0, 3, 6, and 12 months. Microaneurysm (MA) activity using the RetmarkerDR and retinal thickness using spectral-domain optical coherence tomography (SD-OCT) were assessed by a central reading center at all visits and ETDRS severity level in the first and last visits.

RESULTS:

Three hundred thirty-one eyes/patients completed the study. Microaneurysm formation rate greater than or equal to 2 was present in 68.1% of the eyes and MA turnover greater than or equal to 6 in 54.0% at month 6. Higher MA turnover values were registered in eyes that showed progression in ETDRS severity level (P < 0.03). There were also significant correlations between increased microaneurysm activity and increases in retinal thickness. Spectral-domain OCT identified clinical macular edema in 24 eyes/patients (6.7%) and subclinical macular edema in 104 eyes/patients (28.9%) at baseline. Progression of retinal thickening was registered in eyes that had either subclinical or clinical macular edema at baseline.

CONCLUSIONS:

Changes in MA activity measured with RetmarkerDR and in central retinal thickness in eyes with mild nonproliferative diabetic retinopathy and diabetes type 2 are able to identify eyes at risk of progression. These eyes/patients should be selected for inclusion in future clinical trials of drugs targeted to prevent diabetic retinopathy progression to vision-threatening complications. (ClinicalTrials.gov number, NCT01145599.)

PMID:
26322834
DOI:
10.1167/iovs.15-16708
[Indexed for MEDLINE]

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