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Completed

NCT Number: NCT00619034

Pharmacological Intervention in Diabetic Retinopathy

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

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Latanoprost, diclofenac and dorzolamide (eyedrops)

Drug

1 eyedrop twice daily in one week

Other names: Xalatan, Voltaren ophtha, Trusopt

Diclofenac

Drug

dicolfenac eyedrops twice daily i one eye

Other names: Voltaren ophtha

Dorzolamide

Drug

dorzolamide eyedrops twice daily, in one eye for one week

Other names: Trusopt eyedrops

Primary outcomes

  1. Diameter of retinal blood vessels

    Time frame: one year

Secondary outcomes

  1. Influence on retinal blood flow in diabetes

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.

Acronym: XAVOT

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 20, 2008
Registry last updated
Dec 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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