Effect of calcium dobesilate on progression of early diabetic retinopathy: A randomised double-blind study

Graefe’s Arch Clin Exp Ophthalmol

Vol 244, Issue 12, pp 1591–1600

 

Effect of calcium dobesilate on progression of early diabetic retinopathy: A randomised double-blind study

 

1Maria L. Ribeiro , 2Andras I. Seres , 3Angela M. Carneiro , 4Michael Stur , 5Alain Zourdani ,6Patricia Caillon ,7José G. Cunha-Vaz on behalf of the DX-Retinopathy Study Group

 

1J. G. Cunha-Vaz AIBILI, Clinical Trial Centre, Azinhaga de Santa Comba, 3000-548 Coimbra, Portugal, 2Department of Ophthalmology, Semmelweis University, 1083 Budapest, Hungary, 3Department of Ophthalmology, Hospital de São João, 4200 Porto, Portugal ,4Department of Ophthalmology, Medical University of Vienna, 1090 Vienna, Austria, 5Department of Ophthalmology, University-Paris XII-Creteil, 94010 Creteil, France ,6OM PHARMA, Rue du Bois-du-Lan 22,1217 Meyrin/Geneva, Switzerland

 

Abstract

 

Background

The study was carried out to confirm the effect of calcium dobesilate (CaD) compared to placebo (PLA) on the bloodretinal barrier (BRB) permeability in early diabetic retinopathy (DR).

 

Methods

Adults with type II diabetes and early diabetic retinopathy (below level 47 of ETDRS grading and PVPR between 20 and 50×10−6/ min, plasma-free fluorescein) were included in this double-blind placebocontrolled study. Treatment was 2 g daily for 24 months. The primary parameter, posterior vitreous penetration ratio (PVPR), was measured every 6 months by fluorophotometry. Secondary parameters were fundus photography, fluorescein angiography and safety assessments. Metabolic control was performed every 3 months.

 

Results

A total of 194 patients started the treatment (98 CaD, 96 PLA) and 137 completed the 24-month study (69 CaD, 68 PLA). Both treatment groups were comparable at baseline, with ETDRS level 10 in about 59% of patients. Mean PVPR change from baseline after 24 months was significantly (P=0.002) lower in the CaD group [−3.87 (SD 12.03)] than in the PLA group [+2.03 (SD 12.86)], corresponding to a 13.2% decrease in the CaD group and a 7.3% increase in the PLA group. PVPR evolution was also analysed by HbA1c classes (<7%, between 7 and 9%, ≥ 9%) and results confirmed the superiority of CaD independently of the diabetes control level. A highly significant difference [CaD: −3.38 (SD 13.44) versus PLA: +3.50 (SD 13.70)] was also obtained in a subgroup of patients without anti-hypertensive and/or lipid-lowering agents (P=0.002 at 24 months). A further analysis of the secondary parameters showed significant changes in favour of CaD in the evolution from baseline to the last visit of haemorrhages (P=0.029), DR level (P=0.0006) and microaneurysms (P=0.013). Regarding safety, only 2.5% (n=5 patients/events) of all adverse events reported were assessed as possibly or probably related to the test drug, while all serious adverse events were reported as unlikely. There was no statistical difference between groups.

 

Conclusion

Calcium dobesilate 2 g daily for 2 years shows a significantly better activity than placebo on prevention of BRB disruption, independently of diabetes control. Tolerance was very good.

 

(Reference link :https://link.springer.com/article/10.1007/s00417-006-0318-2)