Topical Treatment With Brimonidine and Somatostatin Causes Retinal Vascular Dilation in Patients With Early Diabetic Retinopathy From the EUROCONDOR.

Jakob Grauslund, Ulrik Frydkjaer-Olsen, Tunde Peto, Jimena Fernández-Carneado, Berta Ponsati, Cristina Hernández, José Cunha-Vaz, Rafael Simó

Journal: Investigative ophthalmology & visual science 2019;60(6):2257-2262

PMID: 31112610

Abstract

PURPOSE

Structural retinal microvascular changes have been identified as risk markers of diabetic retinopathy (DR). In order to estimate the retinal response of neuroprotective eye drops, we aimed to evaluate the effect of topical retinal neuroprotection on retinal microvascular changes in early DR.

METHODS

Patients with type 2 diabetes with no or early DR were randomized 1:1:1 to topical treatment with placebo, brimonidine, or somatostatin in a 96-week prospective, phase II to III, European multicenter trial. Retinal vascular calibers were measured semiautomatically in digital fundus images by certified graders at baseline and follow-up and summarized as central retinal arteriolar and venular equivalent (CRAE and CRVE).

RESULTS

Of 449 patients originally included, 297 completed the study with gradable retinal images. Median age and duration of diabetes was 64.5 and 9.9 years, and 65.7% were male. At baseline, Early Treatment Diabetic Retinopathy Study levels were 10 (no DR, 42.8%), 20 (minimal DR, 28.3%), and 35 (mild DR, 29.0%), and CRAE and CRVE did not differ between groups. As opposed to patients with no or minimal DR at baseline, patients with mild DR in the active groups developed a larger retinal arteriolar (brimonidine: +6.2 μm, P = 0.006; somatostatin: +7.2 μm, P = 0.006) and venular (brimonidine: +13.9 μm, P = 0.01; somatostatin: +14.3 μm, P = 0.0001) caliber in contrast to those in the placebo group.

CONCLUSIONS

Topical treatment with brimonidine and somatostatin causes retinal arteriolar and venular dilation in patients with type 2 diabetes and preexisting early DR. Upcoming studies should elaborate on the potential of these findings in arresting early DR.

Address: Department of Ophthalmology, Odense University Hospital, Odense, Denmark.; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Steno Diabetes Center Odense, Odense University Hospital, Odense, Denmark.; Department of Ophthalmology, Odense University Hospital, Odense, Denmark.; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Department of Clinical Research, University of Southern Denmark, Odense, Denmark.; Centre for Public Health, Institute of Clinical Sciences, Queen's University Belfast, Belfast, United Kingdom.; BCN Peptides, Barcelona, Spain.; Diabetes and Metabolism Research Unit, Institut de Recerca Hospital Universitari Vall d'Hebron (VHIR), Barcelona, Spain.; Association for Innovation and Biomedical Research on Light and Image (AIBILI), and University of Coimbra, Coimbra, Portugal.

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