Pharmacological Intervention in Diabetic Retinopathy

Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00619034

Acronym

XAVOT

Enrollment

Registered

2008-02-20

Start date

2007-09-30

Completion date

2010-12-31

Last updated

2010-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Retinopathy

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.

Interventions

DRUGLatanoprost, diclofenac and dorzolamide (eyedrops)

1 eyedrop twice daily in one week

DRUGDiclofenac

dicolfenac eyedrops twice daily i one eye

DRUGDorzolamide

dorzolamide eyedrops twice daily, in one eye for one week

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 35 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Diameter of retinal blood vessels	one year

Secondary

Measure	Time frame
Influence on retinal blood flow in diabetes	one year

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026