Pharmacological Intervention in Diabetic Retinopathy

Study Overview
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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.

Official Title
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Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.

Conditions
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Diabetic Retinopathy

Intervention / Treatment
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* Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)
* Drug: Diclofenac
* Drug: Dorzolamide


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: latanoprost<br>Medical intervention cross-over | Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)<br>* 1 eyedrop twice daily in one week<br>* Other names: Trusopt;|
| Active Comparator: diclofenac<br>medical intervention | Drug: Diclofenac<br>* dicolfenac eyedrops twice daily i one eye<br>* Other names: Voltaren ophtha;|
| Experimental: dorzolamide<br>dorzolamide eyedrops twice daily in one week | Drug: Dorzolamide<br>* dorzolamide eyedrops twice daily, in one eye for one week<br>* Other names: Trusopt eyedrops;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diameter of retinal blood vessels |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence on retinal blood flow in diabetes |  | one year |