Pharmacological Intervention in Diabetic Retinopathy (XAVOT)

December 28, 2010 updated by: University of Aarhus

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 Overview

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 Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: latanoprost
Medical intervention cross-over
1 eyedrop twice daily in one week
Other Names:
  • Xalatan
  • Trusopt
  • Voltaren ophtha
ACTIVE_COMPARATOR: diclofenac
medical intervention
dicolfenac eyedrops twice daily i one eye
Other Names:
  • Voltaren ophtha
EXPERIMENTAL: dorzolamide
dorzolamide eyedrops twice daily in one week
dorzolamide eyedrops twice daily, in one eye for one week
Other Names:
  • Trusopt eyedrops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diameter of retinal blood vessels
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Influence on retinal blood flow in diabetes
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kathrine K Tilma, MD, Department of Ophthalmology - Aarhus, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (ESTIMATE)

February 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 29, 2010

Last Update Submitted That Met QC Criteria

December 28, 2010

Last Verified

December 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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