CClinicalTrials.gg
CompletedNCT00619034XAVOTUpdated Dec 29, 2010

Pharmacological Intervention in Diabetic Retinopathy

An interventional study of Latanoprost, diclofenac and dorzolamide (eyedrops) and Diclofenac in Diabetic Retinopathy, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 20 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-12-29.

Sponsored by University of Aarhus · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
20 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Retinopathy
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 87 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Diabetes type 1 with moderate diabetic retinopathy/healthy
  • Blood pressure \< 135/85 mmHg

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    latanoprost

    Medical intervention cross-over

    Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)

  • Active comparator
    diclofenac

    medical intervention

    Drug: Diclofenac

  • Experimental
    dorzolamide

    dorzolamide eyedrops twice daily in one week

    Drug: Dorzolamide

Interventions

  • DrugLatanoprost, diclofenac and dorzolamide (eyedrops)

    1 eyedrop twice daily in one week

    Also known as: Xalatan, Voltaren ophtha, Trusopt

  • DrugDiclofenac

    dicolfenac eyedrops twice daily i one eye

    Also known as: Voltaren ophtha

  • DrugDorzolamide

    dorzolamide eyedrops twice daily, in one eye for one week

    Also known as: Trusopt eyedrops

06

What researchers measure

Primary outcomes

  1. Diameter of retinal blood vessels

    Time frame: one year

Secondary outcomes

  1. Influence on retinal blood flow in diabetes

    Time frame: one year

07

Study locations

1 site
  • Department of Ophthalmology
    Aarhus, 8000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00619034
Lead sponsor
University of Aarhus
First posted
Feb 20, 2008
Start date
Sep 2007
Primary completion
Dec 2010
Completion
Dec 2010
Last update
Dec 29, 2010

Study contacts

Kathrine K Tilma, MD
principal investigator · Department of Ophthalmology - Aarhus, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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