title: Characterization of Retinal Disease Progression in a 1-Year Longitudinal Study of Eyes With Mild Nonproliferative Retinopathy in Diabetes Type 2.
abstract: OBJECTIVE
  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.)
authors: Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal.
authors: Luisa
authors: L
authors: Ribeiro
authors: Department of Ophthalmology, University Vita Salute-Scientific Institute of San Raffael, Milan, Italy.
authors: Francesco
authors: F
authors: Bandello
authors: Fundación para la Investigacion Biomedica y Sanitaria, FISABIO-OFTALMOLOGIA, Valencia, Spain.
authors: Amparo Navea
authors: AN
authors: Tejerina
authors: Centre for Clinical Trials, Department of Ophthalmology, University of Padova, Padova, Italy.
authors: Stela
authors: S
authors: Vujosevic
authors: G.B. Bietti Eye Foundation-IRCCS, Rome, Italy.
authors: Monica
authors: M
authors: Varano
authors: Clinical Trials Unit, Moorfields Eye Hospital, NHS Foundation Trust, London, United Kingdom.
authors: Catherine
authors: C
authors: Egan
authors: Laser and Retinal Research Unit, King's Health Partners, London, United Kingdom.
authors: Sobha
authors: S
authors: Sivaprasad
authors: Ophthalmology Clinical Trials Unit, Frimley Park Hospital Foundation Trust, Frimley, United Kingdom.
authors: Geeta
authors: G
authors: Menon
authors: Department of Ophthalmology, Lariboisière Hospital, Paris, France.
authors: Pascale
authors: P
authors: Massin
authors: Department of Ophthalmology, Academic Medical Center, Amsterdam, The Netherlands.
authors: Frank D
authors: FD
authors: Verbraak
authors: Department of Ophthalmology, Glostrup Hospital, Copenhagen University, Glostrup, Denmark.
authors: Henrik
authors: H
authors: Lund-Andersen
authors: Rotterdam Eye Hospital, Rotterdam, The Netherlands.
authors: Jose P
authors: JP
authors: Martinez
authors: Institut Català de Retina (ICR), Barcelona, Spain.
authors: Ignasi
authors: I
authors: Jürgens
authors: Antwerp University Hospital, Department of Ophthalmology, Antwerp, Belgium.
authors: Erica
authors: E
authors: Smets
authors: Centre d'Investigation Clinique, Centre National d'Ophtalmologie des Quinze-Vingts, Paris, France.
authors: Caroline
authors: C
authors: Coriat
authors: University Eye Hospital Leipzig, Leipzig, Germany.
authors: Peter
authors: P
authors: Wiedemann
authors: Instituto de Oftalmologia Dr. Gama Pinto, Lisboa, Portugal.
authors: Victor
authors: V
authors: Ágoas
authors: Centre Hospitalier Intercommunal de Creteil, University Paris-Est Creteil, Creteil, France.
authors: Giuseppe
authors: G
authors: Querques
authors: Department of Ophthalmology, University of Bonn, Bonn, Germany.
authors: Frank G
authors: FG
authors: Holz
authors: Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal.
authors: Sandrina
authors: S
authors: Nunes
authors: Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal.
authors: Catarina
authors: C
authors: Neves
authors: Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal.
authors: José
authors: J
authors: Cunha-Vaz
mesh_terms: D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D003930:Diabetic Retinopathy / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology; D018450:Disease Progression; D005500:Follow-Up Studies; D011379:Prognosis; D011446:Prospective Studies; D012160:Retina / Q000473:pathology; D013997:Time Factors; D041623:Tomography, Optical Coherence / Q000379:methods; D014792:Visual Acuity