*Purpose: Type-1 diabetic pancreas and kidney transplant candidates frequently suffer from advanced diabetic retinopathy. Early worsening of diabetic retinopathy (EWDR) attributed to sudden glucose normalization after successful transplantation has been reported by several authors. However, neither its rate nor severity have been studied prospectively so far.

*Methods: We evaluated the rate of EWDR after 1 year in an ongoing prospective randomized study comparing the ophthalmological outcomes in subjects treated either with everolimus or mycophenolic acid as a part of tacrolimus based regimen (EUDRACT No. 2013-004934-14). In 43 pancreas and kidney recipients we followed without regard to immunosuppressive regimen a composite endpoint of EWDR defined as one or more of: 1) new need for laser therapy, 2) newly diagnosed proliferative retinopathy, 3) newly diagnosed macular edema, 4) visual acuity worsening of more than 2 rows, and 5) blindness. Ophthalmological assessment including retinal thickness measurement by optical coherence tomography was performed pre-transplant and at 6 and 12 months post-transplant.

*Results: Though the primary endpoint was met in 37%, its severity was rather low. Mean central retinal thickness and proportion of patients with subclinical macular edema increased temporarily in 6 m with spontaneous resolution in most cases. Visual acuity did not change significantly. There was no difference between subjects meeting and not meeting the primary endpoint in absolute HbA1c levels or its drop at 3 months (see figure), age or diabetes duration (p>0.05), but more patients with progression had recent history of laser treatment (p<0.05). In 62.8% retinopathy remained stabilized, and in 26 % visual acuity improved significantly.

*Conclusions: While worsening was documented in more than 1/3 of patients, its evolution was not related to the magnitude of metabolic change. Our data suggest that early course of diabetic retinopathy after pancreas transplantation depends rather on previous long-term evolution, with newly achieved normoglycemia being a positive factor for later stabilization or improvement.

Supported by Ministry of Health of Czech Republic, grant number 15-26746 A

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