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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

Page last updated: August 23, 2015

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