Pharmacological Intervention in Diabetic Retinopathy - Full Text View

Sponsor:	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) Drug: Diclofenac Drug: Dorzolamide

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention
Official Title:	Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

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

U.S. FDA Resources

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 ]

Enrollment:	87
Study Start Date:	September 2007
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: latanoprost Medical intervention cross-over	Drug: Latanoprost, diclofenac and dorzolamide (eyedrops) 1 eyedrop twice daily in one week Other Names: Xalatan Voltaren ophtha Trusopt
Active Comparator: diclofenac medical intervention	Drug: Diclofenac dicolfenac eyedrops twice daily i one eye Other Name: Voltaren ophtha
Experimental: dorzolamide dorzolamide eyedrops twice daily in one week	Drug: Dorzolamide dorzolamide eyedrops twice daily, in one eye for one week Other Name: Trusopt eyedrops

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 35 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

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

Locations

Denmark
Department of Ophthalmology
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator:

Kathrine K Tilma, MD

Department of Ophthalmology - Aarhus, Denmark

More Information

No publications provided

Responsible Party:	Øjenafd. J, Department of Ophthalmology
ClinicalTrials.gov Identifier:	NCT00619034 History of Changes
Other Study ID Numbers:	2007-001697-84, XAVOT
Study First Received:	February 7, 2008
Last Updated:	December 28, 2010
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diclofenac
Dorzolamide
Tetrahydrozoline
Latanoprost
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012