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Pharmacological Intervention in Diabetic Retinopathy (XAVOT)

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University of Aarhus

Status

Completed

Conditions

Diabetic Retinopathy

Treatments

Drug: Diclofenac
Drug: Dorzolamide
Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)

Study type

Interventional

Funder types

Other

Identifiers

NCT00619034
XAVOT
2007-001697-84

Details and patient eligibility

About

The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.

Full 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.

Enrollment

87 patients

Sex

All

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

87 participants in 3 patient groups

latanoprost
Experimental group
Description:
Medical intervention cross-over
Treatment:
Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)
diclofenac
Active Comparator group
Description:
medical intervention
Treatment:
Drug: Diclofenac
dorzolamide
Experimental group
Description:
dorzolamide eyedrops twice daily in one week
Treatment:
Drug: Dorzolamide

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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