PMID- 26322834 OWN - NLM STAT- MEDLINE DCOM- 20151027 LR - 20220310 IS - 1552-5783 (Electronic) IS - 0146-0404 (Linking) VI - 56 IP - 9 DP - 2015 Aug TI - Characterization of Retinal Disease Progression in a 1-Year Longitudinal Study of Eyes With Mild Nonproliferative Retinopathy in Diabetes Type 2. PG - 5698-705 LID - 10.1167/iovs.15-16708 [doi] AB - 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.) FAU - Ribeiro, Luisa AU - Ribeiro L AD - Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal. FAU - Bandello, Francesco AU - Bandello F AD - Department of Ophthalmology, University Vita Salute-Scientific Institute of San Raffael, Milan, Italy. FAU - Tejerina, Amparo Navea AU - Tejerina AN AD - Fundacion para la Investigacion Biomedica y Sanitaria, FISABIO-OFTALMOLOGIA, Valencia, Spain. FAU - Vujosevic, Stela AU - Vujosevic S AD - Centre for Clinical Trials, Department of Ophthalmology, University of Padova, Padova, Italy. FAU - Varano, Monica AU - Varano M AD - G.B. Bietti Eye Foundation-IRCCS, Rome, Italy. FAU - Egan, Catherine AU - Egan C AD - Clinical Trials Unit, Moorfields Eye Hospital, NHS Foundation Trust, London, United Kingdom. FAU - Sivaprasad, Sobha AU - Sivaprasad S AD - Laser and Retinal Research Unit, King's Health Partners, London, United Kingdom. FAU - Menon, Geeta AU - Menon G AD - Ophthalmology Clinical Trials Unit, Frimley Park Hospital Foundation Trust, Frimley, United Kingdom. FAU - Massin, Pascale AU - Massin P AD - Department of Ophthalmology, Lariboisiere Hospital, Paris, France. FAU - Verbraak, Frank D AU - Verbraak FD AD - Department of Ophthalmology, Academic Medical Center, Amsterdam, The Netherlands. FAU - Lund-Andersen, Henrik AU - Lund-Andersen H AD - Department of Ophthalmology, Glostrup Hospital, Copenhagen University, Glostrup, Denmark. FAU - Martinez, Jose P AU - Martinez JP AD - Rotterdam Eye Hospital, Rotterdam, The Netherlands. FAU - Jurgens, Ignasi AU - Jurgens I AD - Institut Catala de Retina (ICR), Barcelona, Spain. FAU - Smets, Erica AU - Smets E AD - Antwerp University Hospital, Department of Ophthalmology, Antwerp, Belgium. FAU - Coriat, Caroline AU - Coriat C AD - Centre d'Investigation Clinique, Centre National d'Ophtalmologie des Quinze-Vingts, Paris, France. FAU - Wiedemann, Peter AU - Wiedemann P AD - University Eye Hospital Leipzig, Leipzig, Germany. FAU - Agoas, Victor AU - Agoas V AD - Instituto de Oftalmologia Dr. Gama Pinto, Lisboa, Portugal. FAU - Querques, Giuseppe AU - Querques G AD - Centre Hospitalier Intercommunal de Creteil, University Paris-Est Creteil, Creteil, France. FAU - Holz, Frank G AU - Holz FG AD - Department of Ophthalmology, University of Bonn, Bonn, Germany. FAU - Nunes, Sandrina AU - Nunes S AD - Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal. FAU - Neves, Catarina AU - Neves C AD - Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal. FAU - Cunha-Vaz, Jose AU - Cunha-Vaz J AD - Association for Innovation and Biomedical Research on Light and Image (AIBILI) Coimbra, Portugal. CN - Evicr Net Study Group LA - eng SI - ClinicalTrials.gov/NCT01145599 PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Invest Ophthalmol Vis Sci JT - Investigative ophthalmology & visual science JID - 7703701 SB - IM MH - Diabetes Mellitus, Type 2/*complications MH - Diabetic Retinopathy/*diagnosis/etiology/physiopathology MH - Disease Progression MH - Female MH - Follow-Up Studies MH - Humans MH - Male MH - Middle Aged MH - Prognosis MH - Prospective Studies MH - Retina/*pathology MH - Time Factors MH - Tomography, Optical Coherence/*methods MH - *Visual Acuity FIR - Ribeiro, Luisa IR - Ribeiro L FIR - Figueira, Joao IR - Figueira J FIR - Pires, Isabel IR - Pires I FIR - Leal, Sergio IR - Leal S FIR - Simao, Silvia IR - Simao S FIR - Santos, Ana Rita IR - Santos AR FIR - Simoes, Isabel IR - Simoes I FIR - Querques, Giuseppe IR - Querques G FIR - Souied, Eric H IR - Souied EH FIR - Coriat, Caroline IR - Coriat C FIR - Egan, Catherine IR - Egan C FIR - Boston, Hayley IR - Boston H FIR - Degli Esposti, Simona IR - Degli Esposti S FIR - Rocco, Vincent IR - Rocco V FIR - Smets, Erica IR - Smets E FIR - Mathysen, Danny G P IR - Mathysen DG FIR - Massin, Pascale IR - Massin P FIR - Erginay, Ali IR - Erginay A FIR - Holz, Frank G IR - Holz FG FIR - Fleckenstein, Monika IR - Fleckenstein M FIR - Varano, Monica IR - Varano M FIR - Cacciamani, Andrea IR - Cacciamani A FIR - Parravano, Mariacristina IR - Parravano M FIR - Cosimi, Pamela IR - Cosimi P FIR - Verbraak, Frank IR - Verbraak F FIR - Mourits, M IR - Mourits M FIR - Schlingemann, R O IR - Schlingemann R FIR - Wezel, M IR - Wezel M FIR - Jansen-Kok, C IR - Jansen-Kok C FIR - Althoff, A IR - Althoff A FIR - de Vries, D IR - de Vries D FIR - Stam, M IR - Stam M FIR - Wiedemann, Peter IR - Wiedemann P FIR - Jochmann, Claudia IR - Jochmann C FIR - Koch, Christian IR - Koch C FIR - Vollhardt, Daniela IR - Vollhardt D FIR - Tilgner, Christina IR - Tilgner C FIR - Pinto, Gama IR - Pinto G FIR - Agoas, Victor IR - Agoas V FIR - Camacho, Pedro IR - Camacho P FIR - Lund-Andersen, Henrik IR - Lund-Andersen H FIR - Jurgens, Ignasi IR - Jurgens I FIR - Vila, Daniel IR - Vila D FIR - Morilla, Antonio IR - Morilla A FIR - Gonzalez, Lluis IR - Gonzalez L FIR - Martinez, Victor IR - Martinez V FIR - Pedros, Gemma IR - Pedros G FIR - Garcia, Mireia IR - Garcia M FIR - Aradilla, Yolanda IR - Aradilla Y FIR - Martinez, Alexia IR - Martinez A FIR - Escude, Raimon IR - Escude R FIR - Vujosevic, Stela IR - Vujosevic S FIR - Midena, Edoardo IR - Midena E FIR - Martini, Ferdinando IR - Martini F FIR - Urban, Francesca IR - Urban F FIR - Daniele, Anna Rita IR - Daniele AR FIR - Martinez, Jose IR - Martinez J FIR - Tejerina, Amparo Navea IR - Tejerina AN FIR - Fernandez-Lopez, Ester IR - Fernandez-Lopez E FIR - Fandino, Adriana IR - Fandino A FIR - Carmen, M IR - Carmen M FIR - Jord, Pablo Perez IR - Jord PP FIR - Menon, Geeta IR - Menon G FIR - Chandran, Manju IR - Chandran M FIR - North, Lorraine IR - North L FIR - Robson, Deana IR - Robson D FIR - Chekuri, Maheswari IR - Chekuri M FIR - Bandello, Francesco IR - Bandello F FIR - Lattanzio, Rosangela IR - Lattanzio R FIR - Del Turco, Claudia IR - Del Turco C FIR - Alto, Giorgio IR - Alto G FIR - Buzzotta, Alessio IR - Buzzotta A FIR - Marelli, Marta IR - Marelli M FIR - Ribecca, Antonella IR - Ribecca A FIR - Sivaprasad, Sobha IR - Sivaprasad S FIR - Crosby-Nwaobi, Roxanne IR - Crosby-Nwaobi R FIR - Schwartz, Christian IR - Schwartz C FIR - Simao, Silvia IR - Simao S FIR - Neves, Catarina IR - Neves C FIR - Pita, Rui IR - Pita R FIR - Ribeiro, Luisa IR - Ribeiro L FIR - Santos, Ana Rita IR - Santos AR FIR - Ecsodi, Joana IR - Ecsodi J FIR - Nunes, Sandrina IR - Nunes S FIR - Simoes, Sonia IR - Simoes S FIR - Nunes, Sandrina IR - Nunes S FIR - Costa, Miguel IR - Costa M FIR - Cunha-Vaz, Jose IR - Cunha-Vaz J FIR - Martinho, Cecilia IR - Martinho C FIR - Fernandes, Rita IR - Fernandes R EDAT- 2015/09/01 06:00 MHDA- 2015/10/28 06:00 CRDT- 2015/09/01 06:00 PHST- 2015/09/01 06:00 [entrez] PHST- 2015/09/01 06:00 [pubmed] PHST- 2015/10/28 06:00 [medline] AID - 2434745 [pii] AID - 10.1167/iovs.15-16708 [doi] PST - ppublish SO - Invest Ophthalmol Vis Sci. 2015 Aug;56(9):5698-705. doi: 10.1167/iovs.15-16708.