Pharmacological Intervention in Diabetic Retinopathy

Not Applicable

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Latanoprost, diclofenac and dorzolamide (eyedrops); Drug: Diclofenac; Drug: Dorzolamide

• Registration Number: NCT00619034
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-02-07
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-20
• Status Verified: 2010-12
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2010-12-28
• Last Update Posted: 2010-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
latanoprost	Latanoprost, diclofenac and dorzolamide (eyedrops)	Medical intervention cross-over
diclofenac	Diclofenac	medical intervention
dorzolamide	Dorzolamide	dorzolamide eyedrops twice daily in one week

Primary Outcome Measures

Name	Time	Method
Diameter of retinal blood vessels	one year

Secondary Outcome Measures

Name	Time	Method
Influence on retinal blood flow in diabetes	one year

Trial Locations

Locations (1)

Department of Ophthalmology; 🇩🇰 Aarhus, Denmark