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Effect of Choline Fenofibrate (SLV348) on Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Choline Fenofibrate
Placebo
Sponsored by
Abbott Products
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, OCT

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Sites / Locations

  • Site Reference ID/Investigator# 54268
  • Site Reference ID/Investigator# 54291
  • Site Reference ID/Investigator# 54279
  • Site Reference ID/Investigator# 54273
  • Site Reference ID/Investigator# 54267
  • Site Reference ID/Investigator# 54282
  • Site Reference ID/Investigator# 54283
  • Site Reference ID/Investigator# 54270
  • Site Reference ID/Investigator# 54274
  • Site Reference ID/Investigator# 54263
  • Site Reference ID/Investigator# 54284
  • Site Reference ID/Investigator# 54269
  • Site Reference ID/Investigator# 54277
  • Site Reference ID/Investigator# 54275
  • Site Reference ID/Investigator# 54272
  • Site Reference ID/Investigator# 54293
  • Site Reference ID/Investigator# 54265
  • Site Reference ID/Investigator# 54266
  • Site Reference ID/Investigator# 54280
  • Site Reference ID/Investigator# 54264
  • Site Reference ID/Investigator# 54271

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

OCT variables (Retinal Thickness, Retinal thickening)
ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema
Lipids
SBP/DBP, Urinary albumin excretion rate

Full Information

First Posted
May 16, 2008
Last Updated
August 24, 2011
Sponsor
Abbott Products
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1. Study Identification

Unique Protocol Identification Number
NCT00683176
Brief Title
Effect of Choline Fenofibrate (SLV348) on Macular Edema
Official Title
Effect of Choline Fenofibrate (SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects With Diabetic Macular Edema - a One-year, Placebo-Controlled, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Products

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, OCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Choline Fenofibrate
Intervention Description
135 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Total macular volume measurement on OCT, after central reading (assessed at baseline and after 3, 6, 9 and 12 months of treatment)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
OCT variables (Retinal Thickness, Retinal thickening)
Time Frame
12 months
Title
ETDRS macular and hard exudate grading, E-ETDRS visual acuity, ETDRS retina grading, at least 2 step progression, Laser photocoagulation for diabetic macular edema
Time Frame
12 months
Title
Lipids
Time Frame
12 months
Title
SBP/DBP, Urinary albumin excretion rate
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria Previous laser photocoagulation; Eye retinal thickening results from epiretinal membranes or vitreomacular traction; glaucoma; Poor visual acuity: visual acuity of 20/800
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Jean-Claude Ansquer, MD
Organizational Affiliation
Abbott Products
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 54268
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 54291
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 54279
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 54273
City
Sofia
ZIP/Postal Code
1517
Country
Bulgaria
Facility Name
Site Reference ID/Investigator# 54267
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 54282
City
Ostrava-Vitkovice
ZIP/Postal Code
703 84
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 54283
City
Prague
ZIP/Postal Code
169 02
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 54270
City
Usti nad Labem
ZIP/Postal Code
40113
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 54274
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Site Reference ID/Investigator# 54263
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Site Reference ID/Investigator# 54284
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Site Reference ID/Investigator# 54269
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Site Reference ID/Investigator# 54277
City
Gyor
ZIP/Postal Code
H-9023
Country
Hungary
Facility Name
Site Reference ID/Investigator# 54275
City
Zalaegerszeg - Pozva
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Site Reference ID/Investigator# 54272
City
Udine
ZIP/Postal Code
33100
Country
Italy
Facility Name
Site Reference ID/Investigator# 54293
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Site Reference ID/Investigator# 54265
City
Gdansk
ZIP/Postal Code
80-147
Country
Poland
Facility Name
Site Reference ID/Investigator# 54266
City
Katowice
ZIP/Postal Code
40-760
Country
Poland
Facility Name
Site Reference ID/Investigator# 54280
City
Madrid
ZIP/Postal Code
28002
Country
Spain
Facility Name
Site Reference ID/Investigator# 54264
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
Site Reference ID/Investigator# 54271
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom

12. IPD Sharing Statement

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Effect of Choline Fenofibrate (SLV348) on Macular Edema

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