NCT01225653

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

4.1 years

First QC Date

October 20, 2010

Last Update Submit

December 17, 2014

Conditions

Diabetic Retinopathy

Keywords

Latanoprostvasodilationdiabetic retinopathy

Outcome Measures

Primary Outcomes (1)

  • The diameter of retinal arterioles

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

    24 months

Secondary Outcomes (1)

  • The severity of diabetic retinopathy

    24 months

Study Arms (2)

Latanoprost

EXPERIMENTAL

Topical treatment with latanoprost

Drug: Latanoprost

Placebo

PLACEBO COMPARATOR

Placebo arm

Drug: Latanoprost

Interventions

LatanoprostDRUG

Topical application

Also known as: No other names
LatanoprostPlacebo

Eligibility Criteria

Age20 Years - 36 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-36 years old
  • Diabetes mellitus with retinopathy

You may not qualify if:

  • Pregnancy
  • Previous ocular disease other than diabetic retinopathy
  • General disease with possible influence on the eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Århus University Hospital

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Diabetic RetinopathyAneurysm

Interventions

Latanoprost

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Toke Bek, Professor

    Dept of Ophthalmology, Århus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2010

First Posted

October 21, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 18, 2014

Record last verified: 2014-12

Locations

DK(1)