Topical Application of Latanoprost in Diabetic Retinopathy

NCT ID: NCT01225653

Last Updated: 2014-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Retinopathy

Keywords

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Latanoprost vasodilation diabetic retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Latanoprost

Topical treatment with latanoprost

Group Type EXPERIMENTAL

Latanoprost

Intervention Type DRUG

Topical application

Placebo

Placebo arm

Group Type PLACEBO_COMPARATOR

Latanoprost

Intervention Type DRUG

Topical application

Interventions

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Latanoprost

Topical application

Intervention Type DRUG

Other Intervention Names

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No other names

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

36 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toke Bek, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept of Ophthalmology, Århus University Hospital

Locations

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Department of Ophthalmology, Århus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2010-022433-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

Latano-2

Identifier Type: -

Identifier Source: org_study_id