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 Nunes, Catarina Neves, José Cunha-Vaz, Evicr Net Study Group, Luísa Ribeiro, João Figueira, Isabel Pires, Sérgio Leal, Silvia Simão, Ana Rita Santos, Isabel Simões, Giuseppe Querques, Eric H Souied, Caroline Coriat, Catherine Egan, Hayley Boston, Simona Degli Esposti, Vincent Rocco, Erica Smets, Danny G P Mathysen, Pascale Massin, Ali Erginay, Frank G Holz, Monika Fleckenstein, Monica Varano, Andrea Cacciamani, Mariacristina Parravano, Pamela Cosimi, Frank Verbraak, M Mourits, R O Schlingemann, M Wezel, C Jansen-Kok, A Althoff, D de Vries, M Stam, Peter Wiedemann, Claudia Jochmann, Christian Koch, Daniela Vollhardt, Christina Tilgner, Gama Pinto, Victor Ágoas, Pedro Camacho, Henrik Lund-Andersen, Ignasi Jürgens, Daniel Vila, Antonio Morilla, Lluis Gonzalez, Victor Martínez, Gemma Pedrós, Mireia García, Yolanda Aradilla, Alexia Martínez, Raimon Escudé, Stela Vujosevic, Edoardo Midena, Ferdinando Martini, Francesca Urban, Anna Rita Daniele, Jose Martinez, Amparo Navea Tejerina, Ester Fernandez-Lopez, Adriana Fandiño, M Carmen, Pablo Perez Jord, Geeta Menon, Manju Chandran, Lorraine North, Deana Robson, Maheswari Chekuri, Francesco Bandello, Rosangela Lattanzio, Claudia Del Turco, Giorgio Alto, Alessio Buzzotta, Marta Marelli, Antonella Ribecca, Sobha Sivaprasad, Roxanne Crosby-Nwaobi, Christian Schwartz, Silvia Simão, Catarina Neves, Rui Pita, Luisa Ribeiro, Ana Rita Santos, Joana Ecsodi, Sandrina Nunes, Sónia Simões, Sandrina Nunes, Miguel Costa, José Cunha-Vaz, Cecília Martinho, Rita Fernandes, 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 Nunes, Catarina Neves, José Cunha-Vaz, Evicr Net Study Group, Luísa Ribeiro, João Figueira, Isabel Pires, Sérgio Leal, Silvia Simão, Ana Rita Santos, Isabel Simões, Giuseppe Querques, Eric H Souied, Caroline Coriat, Catherine Egan, Hayley Boston, Simona Degli Esposti, Vincent Rocco, Erica Smets, Danny G P Mathysen, Pascale Massin, Ali Erginay, Frank G Holz, Monika Fleckenstein, Monica Varano, Andrea Cacciamani, Mariacristina Parravano, Pamela Cosimi, Frank Verbraak, M Mourits, R O Schlingemann, M Wezel, C Jansen-Kok, A Althoff, D de Vries, M Stam, Peter Wiedemann, Claudia Jochmann, Christian Koch, Daniela Vollhardt, Christina Tilgner, Gama Pinto, Victor Ágoas, Pedro Camacho, Henrik Lund-Andersen, Ignasi Jürgens, Daniel Vila, Antonio Morilla, Lluis Gonzalez, Victor Martínez, Gemma Pedrós, Mireia García, Yolanda Aradilla, Alexia Martínez, Raimon Escudé, Stela Vujosevic, Edoardo Midena, Ferdinando Martini, Francesca Urban, Anna Rita Daniele, Jose Martinez, Amparo Navea Tejerina, Ester Fernandez-Lopez, Adriana Fandiño, M Carmen, Pablo Perez Jord, Geeta Menon, Manju Chandran, Lorraine North, Deana Robson, Maheswari Chekuri, Francesco Bandello, Rosangela Lattanzio, Claudia Del Turco, Giorgio Alto, Alessio Buzzotta, Marta Marelli, Antonella Ribecca, Sobha Sivaprasad, Roxanne Crosby-Nwaobi, Christian Schwartz, Silvia Simão, Catarina Neves, Rui Pita, Luisa Ribeiro, Ana Rita Santos, Joana Ecsodi, Sandrina Nunes, Sónia Simões, Sandrina Nunes, Miguel Costa, José Cunha-Vaz, Cecília Martinho, Rita Fernandes
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.)
Source: PubMed