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A Journal on Ophthalmology
Minerva Oftalmologica 2011 December;53(4):75-82
Assessing the effect of mesoglycan on patients with diabetic retinopathy. REDIM study
Mocellin A. 1, Rollo M. R. 2, Martini R. 1
1 Eye Department “Vito Fazzi”, Eye Hospital, Lecce, Italy
2 Eye Infirmary, Salus Residential Home, Brindisi, Italy
Aim. The aim of this study was to assess the pharmacological effect of mesoglycan treatment on the retinal disorders of patients with non-proliferative diabetic retinopathy (NPDR). Natural visual acuity and corrected visual acuity variations and the assessments of both examiner and patient of final treatment outcome were secondary endpoints.
Methods. Multicenter, uncontrolled, observational, prospective study. We observed 776 eyes of 388 patients with non-proliferative diabetic retinopathy. Each patient received mesoglycan (50 mg/bid) for six consecutive months. Clinical assessments were carried out at zero or baseline, three and six months, by means of fundus biomicroscopy and fluorangiography. A statistical analysis was performed using Mantel-Haenszel test, LOCF and Prevalence test.
Results. At the end of the treatment period a significant improvement (P-value<0.001) of micro-hemorrhages, micro-aneurysms, soft exudates, hard exudates and ischemic areas was observed compared to baseline values. The increase in natural visual acuity at the end of the treatment period was 0.21/10 (IC 95%: 0.10/10, 0.31/10; P-value<0.001). The increase of best corrected visual acuity was 0.13/10 (IC 95%: 0.00/10, 0.25/10; P-value=0.042). The final judgment of the examiner was “improved” in 56.6% of patients, “unchanged” in 37.6% and “worse” in 5.8%. The overall assessment by patients was “improved” in 60.6%, “unchanged” in 32.2% and “worse” in 7.2%.
Conclusion. A treatment with mesoglycan (50 mg/bid) for six consecutive months in non-proliferative diabetic retinopathy is effective to reduce microangiopathic alterations and improve visual acuity.