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

Luisa Ribeiro, Francesco Bandello, Amparo Navea Tejerina, Stela Vujosevic, Monica Varano, Catherine Egan, Sobha Sivaprasad, Geeta Menon, Pascale Massin, Frank D Verbraak, Henrik Lund-Andersen, Jose P Martinez, Ignasi Jürgens, Erica Smets, Caroline Coriat, Peter Wiedemann, Victor Ágoas, Giuseppe Querques, Frank G Holz, Sandrina NunesCatarina Neves, José Cunha-Vaz,

Research output: Contribution to journalArticleResearchpeer-review

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.)

Original languageEnglish
Pages (from-to)5698-705
Number of pages8
JournalInvestigative ophthalmology & visual science
Volume56
Issue number9
DOIs
Publication statusPublished - Aug 2015

Keywords

  • Diabetes Mellitus, Type 2/complications
  • Diabetic Retinopathy/diagnosis
  • Disease Progression
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Prognosis
  • Prospective Studies
  • Retina/pathology
  • Time Factors
  • Tomography, Optical Coherence/methods
  • Visual Acuity

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