Topical Application of Latanoprost in Diabetic Retinopathy (Latano-2)

December 17, 2014 updated by: University of Aarhus
Randomized double-blinded two-year intervention study with topical application of latanoprost or placebo eye drops in patients with diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Århus, Denmark, 8000
        • Department of Ophthalmology, Århus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 36 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo arm
Drug: Latanoprost
Topical application
Other Names:
  • No other names
EXPERIMENTAL: Latanoprost
Topical treatment with latanoprost
Drug: Latanoprost
Topical application
Other Names:
  • No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diameter of retinal arterioles
Time Frame: 24 months
The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Toke Bek, Professor, Dept of Ophthalmology, Århus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

October 20, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (ESTIMATE)

October 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Latano-2
  • 2010-022433-29 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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