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

Primary Purpose

Diabetic Retinopathy

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Latanoprost
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Latanoprost, vasodilation, diabetic retinopathy

Eligibility Criteria

20 Years - 36 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, Århus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Latanoprost

Placebo

Arm Description

Topical treatment with latanoprost

Placebo arm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2010
Last Updated
December 17, 2014
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01225653
Brief Title
Topical Application of Latanoprost in Diabetic Retinopathy
Acronym
Latano-2
Official Title
Topical Application of Latanoprost in Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Latanoprost, vasodilation, diabetic retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Latanoprost
Arm Type
Experimental
Arm Description
Topical treatment with latanoprost
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm
Intervention Type
Drug
Intervention Name(s)
Latanoprost
Other Intervention Name(s)
No other names
Intervention Description
Topical application
Primary Outcome Measure Information:
Title
The diameter of retinal arterioles
Description
The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer
Time Frame
24 months
Secondary Outcome Measure Information:
Title
The severity of diabetic retinopathy
Description
Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toke Bek, Professor
Organizational Affiliation
Dept of Ophthalmology, Århus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Århus University Hospital
City
Århus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Topical Application of Latanoprost in Diabetic Retinopathy

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