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

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ClinicalTrials.gov Identifier: NCT01225653
Recruitment Status : Completed
First Posted : October 21, 2010
Last Update Posted : December 18, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Latanoprost Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Topical Application of Latanoprost in Diabetic Retinopathy
Study Start Date : November 2010
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. The diameter of retinal arterioles [ Time Frame: 24 months ]
    The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer


Secondary Outcome Measures :
  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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 36 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225653


Locations
Denmark
Department of Ophthalmology, Århus University Hospital
Århus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Investigators
Principal Investigator: Toke Bek, Professor Dept of Ophthalmology, Århus University Hospital
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01225653     History of Changes
Other Study ID Numbers: Latano-2
2010-022433-29 ( EudraCT Number )
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014

Keywords provided by University of Aarhus:
Latanoprost
vasodilation
diabetic retinopathy

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