Status:
TERMINATED
Clinical Study of the Effect of Intravenous Galactose on Diabetic Macular Oedema
Lead Sponsor:
Glostrup University Hospital, Copenhagen
Conditions:
Diabetic Macular Oedema
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00427986
Start Date
January 1 2007
End Date
March 1 2007
Last Update
June 26 2007
Active Locations (1)
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1
Department of Ophthalmology, Glostrup Hospital, University of Copenhagen, Nordre Ringvej 57,
Glostrup Municipality, Denmark, DK-2600