NCT00683176

Brief Summary

The purpose of this study is to evaluate the effect of choline fenofibrate on the regression of macular edema in eyes of subjects with type 2 diabetes mellitus (T2DM) presenting with diabetic macular edema (DME)

Trial Health

98
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2008

Geographic Reach
10 countries

21 active sites

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

May 16, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

2.5 years

First QC Date

May 16, 2008

Last Update Submit

August 24, 2011

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular EdemaOCT

Outcome Measures

Primary Outcomes (1)

  • Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)

    12 months

Secondary Outcomes (4)

  • OCT variables (Retinal Thickness, Retinal thickening)

    12 months

  • ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema

    12 months

  • Lipids

    12 months

  • SBP/DBP, Urinary albumin excretion rate

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Choline Fenofibrate

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Choline FenofibrateDRUG

135 mg

1
PlaceboDRUG

Placebo

2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With DME in at least one eye of the subject and this eye presenting with macula thickness ≥ 300 µm on OCT examination at baseline in at least one of the 5 following zones: center zone, or superior inner zone, or nasal inner zone, or inferior inner zone, or temporal inner zone, confirmed after central reading of the OCT;
  • When laser treatment can be safely postponed by up to at least 3 months;
  • With established T2DM and HbA1c \< 10%;
  • With systolic blood pressure (SBP) or diastolic blood pressure (DBP) \< 160/90 mmHg;
  • With documented elevated triglyceride levels (TG \>=150 mg/dL \[1.70 mmol/L\]) at the screening visit or in the previous 3 months.

You may not qualify if:

  • Previous laser photocoagulation;
  • Eye retinal thickening results from epiretinal membranes or vitreomacular traction; glaucoma;
  • Poor visual acuity: visual acuity of 20/800

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Site Reference ID/Investigator# 54268

Sofia, 1000, Bulgaria

Location

Site Reference ID/Investigator# 54291

Sofia, 1233, Bulgaria

Location

Site Reference ID/Investigator# 54279

Sofia, 1408, Bulgaria

Location

Site Reference ID/Investigator# 54273

Sofia, 1517, Bulgaria

Location

Site Reference ID/Investigator# 54267

Brno, 62500, Czechia

Location

Site Reference ID/Investigator# 54282

Ostrava-Vitkovice, 703 84, Czechia

Location

Site Reference ID/Investigator# 54283

Prague, 169 02, Czechia

Location

Site Reference ID/Investigator# 54270

Ústí nad Labem, 40113, Czechia

Location

Site Reference ID/Investigator# 54274

Glostrup Municipality, 2600, Denmark

Location

Site Reference ID/Investigator# 54263

Leipzig, 04103, Germany

Location

Site Reference ID/Investigator# 54284

Münster, 48145, Germany

Location

Site Reference ID/Investigator# 54269

Budapest, 1106, Hungary

Location

Site Reference ID/Investigator# 54277

Győr, H-9023, Hungary

Location

Site Reference ID/Investigator# 54275

Zalaegerszeg - Pozva, 8900, Hungary

Location

Site Reference ID/Investigator# 54272

Udine, 33100, Italy

Location

Site Reference ID/Investigator# 54293

Amsterdam, 1105 AZ, Netherlands

Location

Site Reference ID/Investigator# 54265

Gdansk, 80-147, Poland

Location

Site Reference ID/Investigator# 54266

Katowice, 40-760, Poland

Location

Site Reference ID/Investigator# 54280

Madrid, 28002, Spain

Location

Site Reference ID/Investigator# 54264

Santiago de Compostela, 15705, Spain

Location

Site Reference ID/Investigator# 54271

Liverpool, L7 8XP, United Kingdom

Location

Study Officials

  • Dr Jean-Claude Ansquer, MD

    Abbott Products

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 23, 2008

Study Start

September 1, 2008

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

GB(1)BU(4)HU(3)PL(2)ES(2)DK(1)IT(1)DE(2)CZ(4)NL(1)