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NCT01225653 Clinical Trial

Topical Application of Latanoprost in Diabetic Retinopathy

Diabetic Retinopathy Clinical Trial

— Latano-2  

Official title:
Topical Application of Latanoprost in Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01225653
Other study ID # Latano-2
Secondary ID 2010-022433-29
Status Completed
Phase Phase 4
First received October 20, 2010
Last updated December 17, 2014
Start date November 2010
Est. completion date December 2014

Study information
Verified date December 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics Committee
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 36 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Latanoprost
Topical application

Locations
Country Name City State
Denmark Department of Ophthalmology, Århus University Hospital Århus

Sponsors (2)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary The diameter of retinal arterioles The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer 24 months No
Secondary The severity of diabetic retinopathy Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography 24 months No
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