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

Abstract

BACKGROUND:

The study was carried out to confirm the effect of calcium dobesilate (CaD) compared to placebo (PLA) on the blood-retinal 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 50x10(-6)/ min, plasma-free fluorescein) were included in this double-blind placebo-controlled 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%, > or =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.

• Authors: Maria L Ribeiro, Andras I Seres, Angela M Carneiro, Michael Stur, Alain Zourdani, Patricia Caillon, José G Cunha-Vaz, DX-Retinopathy Study Group
• Journal: Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie (Graefes Arch Clin Exp Ophthalmol) Vol. 244 Issue 12 Pg. 1591-600 (Dec 2006) ISSN: 0721-832X [Print] Germany
• PMID: 16763797 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hemostatics
• Calcium Dobesilate
• Fluorescein

Topics

• Adult
• Aged
• Blood-Retinal Barrier (drug effects)
• Calcium Dobesilate (adverse effects, therapeutic use)
• Capillary Permeability
• Diabetes Mellitus, Type 2 (complications)
• Diabetic Retinopathy (drug therapy, physiopathology)
• Disease Progression
• Double-Blind Method
• Female
• Fluorescein (metabolism)
• Fluorescein Angiography
• Fluorophotometry
• Hemostatics (adverse effects, therapeutic use)
• Humans
• Male
• Middle Aged
• Pilot Projects
• Visual Acuity
• Vitreous Body (metabolism)