Pharmacological Intervention in Diabetic Retinopathy (XAVOT)
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Latanoprost, diclofenac and dorzolamide (eyedrops)
Diclofenac
Dorzolamide
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Retinopathy
Eligibility 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.
Sites / Locations
- Department of Ophthalmology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Experimental
Arm Label
latanoprost
diclofenac
dorzolamide
Arm Description
Medical intervention cross-over
medical intervention
dorzolamide eyedrops twice daily in one week
Outcomes
Primary Outcome Measures
Diameter of retinal blood vessels
Secondary Outcome Measures
Influence on retinal blood flow in diabetes
Full Information
NCT ID
NCT00619034
First Posted
February 7, 2008
Last Updated
December 28, 2010
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT00619034
Brief Title
Pharmacological Intervention in Diabetic Retinopathy
Acronym
XAVOT
Official Title
Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
latanoprost
Arm Type
Experimental
Arm Description
Medical intervention cross-over
Arm Title
diclofenac
Arm Type
Active Comparator
Arm Description
medical intervention
Arm Title
dorzolamide
Arm Type
Experimental
Arm Description
dorzolamide eyedrops twice daily in one week
Intervention Type
Drug
Intervention Name(s)
Latanoprost, diclofenac and dorzolamide (eyedrops)
Other Intervention Name(s)
Xalatan, Voltaren ophtha, Trusopt
Intervention Description
1 eyedrop twice daily in one week
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
Voltaren ophtha
Intervention Description
dicolfenac eyedrops twice daily i one eye
Intervention Type
Drug
Intervention Name(s)
Dorzolamide
Other Intervention Name(s)
Trusopt eyedrops
Intervention Description
dorzolamide eyedrops twice daily, in one eye for one week
Primary Outcome Measure Information:
Title
Diameter of retinal blood vessels
Time Frame
one year
Secondary Outcome Measure Information:
Title
Influence on retinal blood flow in diabetes
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathrine K Tilma, MD
Organizational Affiliation
Department of Ophthalmology - Aarhus, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Pharmacological Intervention in Diabetic Retinopathy
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