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)

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.

Resource links provided by NLM:

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 ]

Estimated Enrollment:	80
Study Start Date:	September 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Medical intervention cross-over	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 K Tilma, MD

+4589493250

kathtilm@rm.dk

Locations

Denmark
Department of Ophthalmology	Recruiting
Aarhus, Denmark, 8000
Contact: Kathrine K Tilma, MD +45 89493250 kathtilm@rm.dk
Principal Investigator: Kathrine K Tilma, MD

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:	Department of Ophthalmology ( Øjenafd. J )
Study ID Numbers:	2007-001697-84, XAVOT
Study First Received:	February 7, 2008
Last Updated:	November 30, 2009
ClinicalTrials.gov Identifier:	NCT00619034 History of Changes
Health Authority:	Denmark: Danish Medicines Agency

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Diabetic Angiopathies
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Analgesics
Diabetes Complications
Retinal Diseases
Eye Diseases
Cyclooxygenase Inhibitors
Diabetes Mellitus
Vascular Diseases

Diclofenac
Endocrine System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Diabetic Retinopathy
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dorzolamide

ClinicalTrials.gov processed this record on February 08, 2010