- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00619034
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
Status
Completed
Conditions
Intervention / Treatment
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:
|
ACTIVE_COMPARATOR: diclofenac
medical intervention
|
dicolfenac eyedrops twice daily i one eye
Other Names:
|
EXPERIMENTAL: dorzolamide
dorzolamide eyedrops twice daily in one week
|
dorzolamide eyedrops twice daily, in one eye for one week
Other Names:
|
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Diabetic Retinopathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Carbonic Anhydrase Inhibitors
- Pharmaceutical Solutions
- Dorzolamide
- Ophthalmic Solutions
- Diclofenac
- Latanoprost
Other Study ID Numbers
- 2007-001697-84
- XAVOT
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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