Status:
TERMINATED
Study Investigating the Levels and Effects of Low-grade Inflammation in Diabetic Retinopathy of Type 1 Diabetes
Lead Sponsor:
Medical University of Vienna
Conditions:
Diabetic Retinopathy
Inflammation
Eligibility:
All Genders
18+ years
Brief Summary
There is much evidence that localized low grade inflammatory processes may contribute to the microvascular complications of type 1 and type 2 diabetes mellitus including sight-threatening diabetic ret...
Eligibility Criteria
Inclusion
- Patients with type 1 diabetes mellitus with duration of \> 1 year
- Men and women, age ≥ 18, nonsmokers
- Body mass index between 16 and 30 kg/m²
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant or diabetes-related
- Mild, moderate or severe non-proliferative diabetic retinopathy
Exclusion
- Abuse of drugs or alcoholic beverages
- Participation in a clinical trial in the 3 weeks preceding the study
- Treatment with anti-inflammatory drugs in the 3 weeks before the study day
- Symptoms of a clinically relevant illness in the 3 weeks before the study day
- Blood donation or equivalent blood loss in the 3 weeks before the study day
- Other ocular pathologies than non-proliferative diabetic retinopathy
- Ametropia \> 6 dpt
- History or family history of epilepsy
- Pregnant or lactating women
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00880139
Start Date
June 1 2009
End Date
September 1 2012
Last Update
November 14 2014
Active Locations (1)
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1
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, Austria