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Completed

NCT Number: NCT00683176

Effect of Choline Fenofibrate (SLV348) on Macular Edema

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)

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Key information

Conditions

Diabetic Macular Edema

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site Reference ID/Investigator# 54268, Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choline Fenofibrate

Drug

135 mg

Placebo

Drug

Placebo

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)

    Time frame: 12 months

Secondary outcomes

  1. OCT variables (Retinal Thickness, Retinal thickening)

    Time frame: 12 months

  2. 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

  3. Lipids

    Time frame: 12 months

  4. SBP/DBP, Urinary albumin excretion rate

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Abbott Products

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 23, 2008
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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