Abstract
Abstract: :
Objective: Doxium® (DX, Calcium dobesilate) has been shown to reduce retinal vessel hyperpermeability and leakage from vascular lesions. The aim of this study is to confirm the efficacy of DX on the Blood–Retinal Barrier (BRB) permeability. Methods:Adult patients, aged 35 to 70, with type 2 diabetes and early diabetic retinopathy (DR) confirmed by stereoscopic fundus photography (up to level 47 of Wisconsin grading) and vitreous fluorophotometry were enrolled in this double–blind, placebo–controlled, 6–center study. Treatment regimen was 4x500 mg (2g) daily during 24 months. The evolution of the Posterior Vitreous Penetration Ratio (PVPR) of the eye defined as "worst" at baseline was assessed by vitreous fluorophotometry (Ocumetrics Fluorotron Master) performed at 6–month intervals. Stereoscopic fundus photography and fluorescein angiography were carried out at the same frequency. Laboratory evaluations were performed at 3–month intervals. 194 patients were randomised (98 DX and 96 PL), 137 completed the study period (69 DX and 68 PL). Results: PVPR global evolution, analysed by ANCOVA of least squares regression, showed significant superiority of DX over PL (p=0.0378) with mean slopes of respectively –0.142 (SE 0.050) and +0.010 (SE 0.052). Moreover, mean PVPR (difference with baseline) was significantly lower at the end of treatment period in DX group (–3.87 (SD 12.03)) than in PL group (+2.03 (SD 12.86)), Δ=–5.91 (95%CI –10.20 –1.62, p=0.0016). Conclusions: Treatment with DX 2g per day during 24 months had a significant effect on the evolution of the BRB permeability with placebo showing an increase in retinal leakage. Tolerance was very good and similar for both treatment groups.
Keywords: diabetes • diabetic retinopathy • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials