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The CALDIRET-Study - A Randomized Double-blinded Multi-Center-Study. Can Calciumdobesilate Delay the Formation of Clinically Significant Diabetic Macular Edema?
Ulbig M., Kampik A.,
Ludwig-Maximilians-Universität München, Klinikum Innenstadt, Augenklinik (München)
Objective: Doxium®, Calciumdobesilate is thought to restore the blood retinal barrier by protection versus sorbitol in vascular endothelial cells and to improve on retinal circulation. The Caldiret Study was designed to show a beneficial effect.
Patients and methods: 635 adult onset diabetics with an age from 40 to 68 years and satisfactory control measured by HbA1c levels and mild to moderate NPDR were recruited. Patients had no Doxium intake during previous 12 months. Diastolic blood pressure was below 100 mm Hg and proteinuria between 20 and 200 mg/l. Informed consent was provided. Exclusion criteria were new vessels, signs of macular edema, media opacities precluding high quality fundus stereo photography to ETDRS standards, previous laser treatment or vitrectomy for diabetic retinopathy, pregnancy, and need for hemodialysis. Fundus photographs were evaluated in one reading center.
Results: The study started in August 1996 and is scheduled to last until 2003. Patients are photographed and examined twice a year. Overall 40 centers are involved, 21 in Germany, Austria, and Switzerland, and 19 in eastern Europe. All patients were enrolled by the end of 1998. Daily 1500 mg of Calciumdobesilate or placebo are administered. Mean HbA1c-levels were 8.1 in Germany, Austria, and Switzerland, and 8.3 in eastern Europe. Patients' mean age was 58 years at inclusion. By April 2002 129 endpoints (clinically significant macular edema) had occurred, 174 patients had been withdrawn, and 303 were ongoing.
Conclusions: The Caldiret-study enrolled the required number of patients. The occurrence of clinical endpoints is satisfactory. There was no difference in quality of control of diabetes in western and eastern Europe at entry. We are looking forward to answer interesting epidemiological aspects of diabetic macular edema and the question as to whether calciumdobesilate is beneficial in the prevention.