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

This study is currently recruiting participants. (see Contacts and Locations)
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

October 20, 2010
September 11, 2012
November 2010
November 2014   (final data collection date for primary outcome measure)
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
The diameter of retinal arterioles [ Time Frame: After 24 months ] [ Designated as safety issue: No ]
The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer
Complete list of historical versions of study NCT01225653 on ClinicalTrials.gov Archive Site
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
The severity of diabetic retinopathy [ Time Frame: After 24 months ] [ Designated as safety issue: No ]
Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography
Not Provided
Not Provided
 
Topical Application of Latanoprost in Diabetic Retinopathy
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Diabetic Retinopathy
Drug: Latanoprost
Topical application
Other Name: No other names
  • Experimental: Latanoprost
    Topical treatment with latanoprost
    Intervention: Drug: Latanoprost
  • Placebo Comparator: Placebo
    Placebo arm
    Intervention: Drug: Latanoprost
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2014
November 2014   (final data collection date for primary outcome measure)

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
Both
20 Years to 36 Years
No
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
Denmark
 
NCT01225653
Latano-2, 2010-022433-29
Yes
University of Aarhus
University of Aarhus
Aarhus University Hospital
Principal Investigator: Toke Bek, Professor Dept of Ophthalmology, Århus University Hospital
University of Aarhus
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP