Clinical Study of the Effect of Intravenous Galactose on Diabetic Macular Oedema

• Status: Terminated
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the present study is to examine, if retinal swelling in diabetic patients can be reduced by an intravenous injection of galactose.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Glostrup University Hospital, Copenhagen

Criteria

Inclusion Criteria:

• Type 1 or type 2 diabetes

• clinically significant macular oedema

• visual acuity of minimum 40 letters by the ETDRS procedure

• retinal thickness of at least 250 microns in the foveal region on three retinal maps of the fast protocol of the StratusOCT at baseline or at least 300 microns outside the foveal region

• 1 disc area of oedema within 3000 microns from the foveal center on three retinal maps of the fast protocol of the StratusOCT at baseline

• maximal blood pressure 160/90 mmHg (mean of three measurements)

• informed consent

Exclusion Criteria:

• other ocular diseases or treatments, that can cause or influence the macular oedema, including prior laser photocoagulation. Traction oedema is allowed.

• glaucoma

• media opacities that significantly impairs the light reflection while scanning

• Pregnancy

• severe heart, lung and/or renal insufficiency (judged by the primary investigator)