Pharmacological Intervention in Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

— XAVOT  

Official title:

Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619034
• Other study ID #: 2007-001697-84
• Secondary ID: XAVOT
• Status: Completed
• Phase: N/A
• First received: February 7, 2008
• Last updated: December 28, 2010
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 35 Years

Eligibility

Inclusion Criteria:

• Diabetes type 1 with moderate diabetic retinopathy/healthy

• Blood pressure < 135/85 mmHg

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Latanoprost, diclofenac and dorzolamide (eyedrops)
1 eyedrop twice daily in one week
• Diclofenac
dicolfenac eyedrops twice daily i one eye
• Dorzolamide
dorzolamide eyedrops twice daily, in one eye for one week

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diameter of retinal blood vessels		one year
Secondary	Influence on retinal blood flow in diabetes		one year