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Effects of Topically Administered Neuroprotective Drugs in Early Stages of Diabetic Retinopathy: Results of the EUROCONDOR Clinical Trial

2018; American Diabetes Association; Volume: 68; Issue: 2 Linguagem: Inglês

10.2337/db18-0682

1939-327X

Rafael Simó, Cristina Hernández, Massimo Porta, Francesco Bandello, Jakob Grauslund, Simon Harding, S J Aldington, Catherine Egan, Ulrik Frydkjær-Olsen, José García‐Arumí, Jonathan Gibson, Gabriele E. Lang, Rosangela Lattanzio, Pascale Massin, Edoardo Midena, Berta Ponsati, Luísa Ribeiro, Peter H. Scanlon, Conceição Lobo, Miguel Costa, José Cunha‐Vaz, Rafael Simó, Cristina Hernández, Marta García‐Ramírez, E. van Reck, Emilio Gil‐Martín, Morillas Bueno M, José Cunha‐Vaz, Luísa Ribeiro, Conceição Lobo, Marlene Costa, Sandrina Nunes, João Figueira, I. Pereira-Marques, Celestino Neves, Charles E. Schwartz, Massimo Porta, Marina Trento, Olga Durando, Sebastjan Merlo, Francesco Bandello, Rosangela Lattanzio, Ilaria Zucchiatti, Jakob Grauslund, Ulrik Frydkjær-Olsen, Simon Harding, Peter H. Scanlon, S J Aldington, Va Jones, Lisa D. Johnson, S. Carter, John Spurway, Catherine Egan, Simona Degli Esposti, Lauren Leitch-Devlin, Vincent P. Rocco, Alyson Rees, José García‐Arumí, Miguel Ángel Zapata, Anna Boixadera, C. Macià, Laura Distéfano, T. Torrent, F. Casals, N. de Dios, Jonathan Gibson, Gabriele E. Lang, W. Jens-Ulrich, Emily J. B. Christian, Adnan Khashman, Pascale Massin, Ali Erginay, Edoardo Midena, Stela Vujosevic, Elisabetta Pilotto, Evelyn Longhin, Enrica Convento, Berta Ponsati, Jimena Fernández‐Carneado, S. Arrastia-Casado, S. Orgué, Dolores T. Ramírez-Lamelas, Ana Almazán-Moga, Antoni Salvà, Ludovica Riera,

Retinal Imaging and Analysis

The primary objective of this study was to assess whether the topical administration of two neuroprotective drugs (brimonidine and somatostatin) could prevent or arrest retinal neurodysfunction in patients with type 2 diabetes. For this purpose, adults aged between 45 and 75 years with a diabetes duration ≥5 years and an Early Treatment of Diabetic Retinopathy Study (ETDRS) level of ≤35 were randomly assigned to one of three arms: placebo, somatostatin, or brimonidine. The primary outcome was the change in implicit time (IT) assessed by multifocal electroretinography between baseline and at the end of follow-up (96 weeks). There were 449 eligible patients allocated to brimonidine (n = 152), somatostatin (n = 145), or placebo (n = 152). When the primary end point was evaluated in the whole population, we did not find any neuroprotective effect of brimonidine or somatostatin. However, in the subset of patients (34.7%) with preexisting retinal neurodysfunction, IT worsened in the placebo group (P < 0.001) but remained unchanged in the brimonidine and somatostatin groups. In conclusion, the topical administration of the selected neuroprotective agents appears useful in preventing the worsening of preexisting retinal neurodysfunction. This finding points to screening retinal neurodysfunction as a critical issue to identify a subset of patients in whom neuroprotective treatment might be of benefit.