AdRem

1.602 patients, 42 sites, finalised 2008
The ADVANCE Retinal Measurements (AdRem) is a sub-study of the Action in Diabetes and Vascular disease: Preterax and Diamicron MR Controlled Evaluation (ADVANCE) Trial. The study was designed to provide reliable evidence on the effects of intensive glucose control and blood pressure lowering on diabetic retinopathy and abnormalities of retinal vasculature in patients with type 2 diabetes mellitus. Primary outcome was progression of two or more steps in Early Treatment of Diabetic Retinopathy Study (ETDRS) classification. Secondary outcomes included progression of retinal vascular lesions and distortion of retinal vascular geometry.
The AdRem study was a randomised (using a central, computer-based procedure) controlled 2x2 factorial trial conducted from 2001 to 2008. It comprised a double-blind comparison of blood pressure lowering with perindopril-indapamide vs placebo, and an open comparison of standard vs intensive glucose control targeting HbA(1c) of < or = 6.5% in 1.602 diabetic patients from ADVANCE centres. At baseline and the final visit, seven-field stereoscopic retinal photographs were taken and graded by blinded readers (gradable baseline and final photographs were from 1.241 patients).
The AdRem study was performed in 42 sites. These sites were located in 15 countries: Australia, India, Malaysia, Philippines, Canada, China, France, Germany, the Netherlands, Poland, Slovakia, Estonia, Ireland, Lithuania and the United Kingdom.

The Julius Center was the AdRem Coordinating center, providing services as data management, processing, digitising and grading of all images.

Publications:
Beulens JW, Patel A, Vingerling JR, Cruickshank JK, Hughes AD, Stanton A, Lu J, McG Thom SA, Grobbee DE, Stolk RP; AdRem project team; ADVANCE management committee. Effects of blood pressure lowering and intensive glucose control on the incidence and progression of retinopathy in patients with type 2 diabetes mellitus: a randomised controlled trial. Diabetologia 2009;52(10):2027-36.

Stolk RP, Vingerling JR, Cruickshank JK, Hughes AD, Stanton A, Juming L, Patel A, Thom SA, Grobbee DE. Rationale and design of the AdRem study: evaluating the effects of blood pressure lowering and intensive glucose control on vascular retinal disorders in patients with type 2 diabetes mellitus. Contemp Clin Trials 2007;28(1):6-17.

Stolk RP, van Schooneveld MJ, Cruickshank JK, Hughes AD, Stanton A, Lu J, Patel A, Thom SA, Grobbee DE, Vingerling JR. Retinal vascular lesions in patients with type 2 diabetes mellitus of Caucasian and Asian origin - baseline results from the AdRem study. Diabetes Care 2008;31(4):708-13.