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

Rafael Simó, Cristina Hernández, Massimo Porta, Francesco Bandello, Jakob Grauslund, Simon P Harding, Stephen J Aldington, Catherine Egan, Ulrik Frydkjaer-Olsen, José García-Arumí, Jonathan Gibson, Gabriele E Lang, Rosangela Lattanzio, Pascale Massin, Edoardo Midena, Berta Ponsati, Luísa Ribeiro, Peter Scanlon, Conceição Lobo, Miguel Ângelo Costa, José Cunha-Vaz

Journal: Diabetes 2019;68(2):457-463

PMID: 30389750

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Abstract

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 ( = 152), somatostatin ( = 145), or placebo ( = 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 ( < 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.

Address: Diabetes and Metabolism Research Unit and CIBERDEM, Vall d'Hebron Research Institute, Barcelona, Spain [email protected] [email protected].; Diabetes and Metabolism Research Unit and CIBERDEM, Vall d'Hebron Research Institute, Barcelona, Spain.; Department of Medical Sciences, University of Turin, Turin, Italy.; Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy.; Research Unit of Ophthalmology, Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, U.K.; Gloucestershire Hospitals National Health Service Foundation Trust, Cheltenham, U.K.; Moorfields Eye Hospital National Health Service Foundation Trust, Institute of Ophthalmology/University College London, London, U.K.; Department of Ophthalmology, Vall d'Hebron University Hospital, Barcelona, Spain.; Department of Vision Sciences, Aston University, Birmingham, U.K.; Department of Ophthalmology, University of Ulm, Ulm, Germany.; Department of Ophthalmology, Lariboisière Hospital, Paris, France.; Department of Ophthalmology, University of Padova, Padova, Italy.; BCN Peptides, Barcelona, Spain.; Association for Innovation and Biomedical Research on Light and Image (AIBILI), Coimbra, Portugal, and Faculty of Medicine, University of Coimbra, Ophthalmology Department, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal.

DOI: 10.2337/db18-0682

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MeSH Terms: Administration, Topical, Aged, Brimonidine Tartrate, Diabetes Mellitus, Type 2, Diabetic Retinopathy, Humans, Middle Aged, Neuroprotective Agents, Somatostatin