Pharmacological Intervention in Diabetic Retinopathy
Information source: University of Aarhus
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Retinopathy
Intervention: Latanoprost, diclofenac and dorzolamide (eyedrops) (Drug); Diclofenac (Drug); Dorzolamide (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Aarhus Official(s) and/or principal investigator(s):
Kathrine K Tilma, MD, Principal Investigator, Affiliation: Department of Ophthalmology - Aarhus, Denmark
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.
Clinical Details
Official title: Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Primary outcome: Diameter of retinal blood vessels
Secondary outcome: Influence on retinal blood flow in diabetes
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
Minimum age: 20 Years.
Maximum age: 35 Years.
Gender(s): Both.
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.
Locations and Contacts
Department of Ophthalmology, Aarhus 8000, Denmark
Additional Information
Starting date: September 2007
Last updated: December 28, 2010
|
