Diabetic Macular Oedema Clinical Trial
Official title:
Diabetic Macular Oedema: Quantification of the Effect of Rising the Intracapillary Osmotic Pressure With Intravenous Galactose on the Retinal Thickness
The purpose of the present study is to examine, if retinal swelling in diabetic patients can be reduced by an intravenous injection of galactose.
Macular oedema (swelling of the retina) is a leading cause of severe visual loss and
blindness in patients with diabetes. The oedema is caused by fluid accumulation in the
retinal tissue from leaking capillaries and leads to an increase in the retinal thickness.
Optical Coherence Tomography (OCT) has become the primary technique to estimate the retinal
thickness objectively, and the scans can be performed without any discomfort to the patient
after dilation of the pupils.
According to the Starling equation, a general basic physiologic rule, specific factors
influence the fluid transport between the capillaries and the surrounding tissue. One of
these factors is the balance between the large molecules within the vessel lumen and the
surrounding tissue, e.g. the osmotic pressure balance. By changing the osmotic balance some
drugs can reduce the fluid content in the tissue by extracting water from the tissue to the
vessel lumen. Such a drug is galactose.
In the present study we examine, if treatment with intravenous galactose can reduce the
retinal thickness in diabetic macular oedema evaluated by OCT during a three-hour monitoring.
Galactose (0.5 mg/mL) is administered as 1 mL galactose per kg body weight + 10% with a
maximum of 80 mL, and injection time is 5 min. If reduction of the thickness with galactose
is found, it then confirms the application of the Starling osmotic forces on diabetic macular
oedema. In the same time span series of venous blood samples are taken for analysis of plasma
osmolarity and electrolytes. The systemic blood pressure is also monitored as well as the
capillary glucose level.
As diurnal variations in the retinal thickness estimates potentially can influence the
results, the OCT measurements and blood samples are repeated on a second day for each
participant, without treatment with galactose for comparison. The order of two visits is
given by randomisation.
Interim analysis will take place after inclusion of 15 to 20 patients to evaluate the need
for inclusion of 45 patients.
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