Pharmacological Intervention in Diabetic Retinopathy - Full Text View

Sponsored by:	University of Aarhus
Information provided by:	University of Aarhus
ClinicalTrials.gov Identifier:	NCT00619034

Purpose

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

Condition	Intervention
Diabetic Retinopathy	Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

Drug Information available for: Latanoprost Dorzolamide Dorzolamide hydrochloride Tetrahydrozoline Tetrahydrozoline hydrochloride Diclofenac Diclofenac potassium Diclofenac sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

Diameter of retinal blood vessels [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Influence on retinal blood flow in diabetes [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	September 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Latanoprost, diclofenac and dorzolamide (eyedrops) 1 eyedrop twice daily in one week

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.

Eligibility

Ages Eligible for Study:	20 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619034

Contacts

Contact: Kathrine B Tilma, MD

+4589493250

katht@as.aaa.dk

Locations

Denmark
Department of Ophthalmology	Recruiting
Aarhus, Denmark, 8000
Contact: Kathrine B Tilma, MD +45 89493250 katht@as.aaa.dk
Principal Investigator: Kathrine B Tilma, MD

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Kathrine B Tilma, MD

Department of Ophthalmology - Aarhus, Denmark

More Information

Responsible Party:	Department of Ophthalmology ( Øjenafd. J )
Study ID Numbers:	2007-001697-84, XAVOT
Study First Received:	February 7, 2008
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00619034
Health Authority:	Denmark: Danish Medicines Agency

Study placed in the following topic categories:

Eye Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Diclofenac
Tetrahydrozoline
Latanoprost

Diabetic Angiopathies
Diabetic Retinopathy
Endocrinopathy
Retinal Diseases
Diabetes Complications
Dorzolamide

Additional relevant MeSH terms:

Carbonic Anhydrase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009