Topical Application of Latanoprost in Diabetic Retinopathy

Phase 4

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Drug: Latanoprost

• Registration Number: NCT01225653
• Lead Sponsor: University of Aarhus

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.

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-21
• Study Start: 2010-11
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-17
• Last Update Posted: 2014-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Latanoprost	Latanoprost	Topical treatment with latanoprost
Placebo	Latanoprost	Placebo arm

Primary Outcome Measures

Name	Time	Method
The diameter of retinal arterioles	24 months	The diameter of retinal arterioles will be assessed using the Dynamic Vessel Analyzer

Secondary Outcome Measures

Name	Time	Method
The severity of diabetic retinopathy	24 months	Severity of diabetic retinopathy will be measured by optical coherence tomography (OCT) scanning and fundus photography

Trial Locations

Locations (1)

Department of Ophthalmology, Århus University Hospital; 🇩🇰 Århus, Denmark