Official Title: “Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.”

The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.

Study Type: Interventional

Study Design: Prevention, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Disturbances in retinal perfusion is believed to be involved in the pathophysiology of diabetic retinopathy. These disturbances may be due to changes in the basal diameter of retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels when the blood pressure and the retinal metabolism changes. In vitro studies have shown that prostaglandins and carbonic anhydrases inhibitors are involved in the tone regulation of retinal arterioles, but it is unknown whether this finding is relevant in clinical practice.

This can be tested in vivo by an retinal vessel analyzer measuring the dynamics of the retinal vessel diameter changes.

Intervention(s) in this Clinical Trial

• Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)
  • 1 eyedrop twice daily in one week

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Diameter of retinal blood vessels
  • Time Frame: one year
    Safety Issue?: No

Secondary Measures

• Influence on retinal blood flow in diabetes
  • Time Frame: one year
    Safety Issue?: No

Inclusion Criteria:

• Diabetes type 1 with moderate diabetic retinopathy/healthy
• Blood pressure < 135/85 mmHg
• HbAlc < 9%

Exclusion Criteria:

• Eye disease (excluding diabetic retinopathy)
• Allergic
• Kidney disease
• Liver disease
• Severe asthma
• Heart disease
• Hypertension arterial
• Users of drugs that influence the metabolism of the prostaglandins in the carbon dioxide
• Pregnant and breastfeeding women and women who don't use secure contraception
• Persons who can't do without contact lens in the treated eye.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Aarhus

Overall Clinical Trial Officials and Contacts

Kathrine B Tilma, MD Principal Investigator Department of Ophthalmology - Aarhus, Denmark  

Overall Contact: Kathrine B Tilma, MD +4589493250 katht@as.aaa.dk

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00619034

Study ID Number: 2007-001697-84

ClinicalTrials.gov Identifier: NCT00619034

Health Authority: Denmark: Danish Medicines Agency