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Pharmacological Intervention in Diabetic Retinopathy

NCT ID: NCT00619034

Last Updated: 2010-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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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.

Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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latanoprost

Medical intervention cross-over

Group Type EXPERIMENTAL

Latanoprost, diclofenac and dorzolamide (eyedrops)

Intervention Type DRUG

1 eyedrop twice daily in one week

diclofenac

medical intervention

Group Type ACTIVE_COMPARATOR

Diclofenac

Intervention Type DRUG

dicolfenac eyedrops twice daily i one eye

dorzolamide

dorzolamide eyedrops twice daily in one week

Group Type EXPERIMENTAL

Dorzolamide

Intervention Type DRUG

dorzolamide eyedrops twice daily, in one eye for one week

Interventions

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Latanoprost, diclofenac and dorzolamide (eyedrops)

1 eyedrop twice daily in one week

Intervention Type DRUG

Diclofenac

dicolfenac eyedrops twice daily i one eye

Intervention Type DRUG

Dorzolamide

dorzolamide eyedrops twice daily, in one eye for one week

Intervention Type DRUG

Other Intervention Names

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Xalatan Voltaren ophtha Trusopt Voltaren ophtha Trusopt eyedrops

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Department of Ophthalmology

Principal Investigators

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Kathrine K Tilma, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology - Aarhus, Denmark

Locations

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Department of Ophthalmology

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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XAVOT

Identifier Type: -

Identifier Source: secondary_id

2007-001697-84

Identifier Type: -

Identifier Source: org_study_id