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Completed

NCT Number: NCT01225653

Topical Application of Latanoprost in Diabetic Retinopathy

Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.

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Key information

Conditions

Diabetic Retinopathy Aneurysm Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

20 year–36 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Ophthalmology, Århus University Hospital

Aarhus, 8000, Denmark

About this study

The primary objective is to study if a sustained contraction of pathologically dilated retinal arterioles can be obtained. Retinal arteriolar diameter and the diameter response to increased blood pressure is studied using the Dynamic Vessel Analyzer (Imedos, Germany.

The secondary objective is to study whether the intervention can halt the development of diabetic retinopathy, which is assessed by optical coherence tomography (OCT) scanning and fundus photography.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 20-36 years old
  • Diabetes mellitus with retinopathy

Exclusion criteria

  • Pregnancy
  • Previous ocular disease other than diabetic retinopathy
  • General disease with possible influence on the eye

Treatment and study plan

latanoprost

Drug

Topical application

Other names: No other names

Primary outcomes

  1. The diameter of retinal arterioles

    Time frame: 24 months

    The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer

Secondary outcomes

  1. The severity of diabetic retinopathy

    Time frame: 24 months

    Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital

Registry information

Acronym: Latano-2

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 21, 2010
Registry last updated
Dec 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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