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

This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01225653
First received: October 20, 2010
Last updated: September 11, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetic Retinopathy
 Drug: Latanoprost
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Topical Application of Latanoprost in Diabetic Retinopathy

Resource links provided by NLM:

Drug Information available for: Latanoprost
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • The diameter of retinal arterioles [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer


Secondary Outcome Measures:
  • The severity of diabetic retinopathy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography


Estimated Enrollment: 50
Study Start Date: November 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Latanoprost
Topical treatment with latanoprost
 Drug: Latanoprost
Topical application
Other Name: No other names
Placebo Comparator: Placebo
Placebo arm
 Drug: Latanoprost
Topical application
Other Name: No other names

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.

  Eligibility

Ages Eligible for Study:   20 Years to 36 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225653

Contacts
Contact: Toke Bek, MD, PhD +45 7846 3222 toke.bek@mail.tele.dk
Contact: Christina Moerup Joergensen, MD, PhD student +45 7846 3222 chrisjoe@rm.dk

Locations
Denmark
Department of Ophthalmology, Århus University Hospital Recruiting
Århus, Denmark, 8000
Contact: Toke Bek, Professor     +45 89493223     toke.bek@mail.tele.dk    
Principal Investigator: Toke Bek, Professor            
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Toke Bek, Professor Dept of Ophthalmology, Århus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01225653     History of Changes
Other Study ID Numbers: Latano-2, 2010-022433-29
Study First Received: October 20, 2010
Last Updated: September 11, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee

Keywords provided by University of Aarhus:
Latanoprost
vasodilation
diabetic retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
 Diabetes Mellitus
Endocrine System Diseases
Latanoprost
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013