Effect of Choline Fenofibrate (ABT-335 /SLV348) on Macular Edema Measured by Optical Coherence Tomography in Subjects with Diabetic Macular Edema - a one-year, Placebo-Controlled, Randomized Study

• Conditions: Diabetic macular edema; MedDRA version: 9.1Level: LLTClassification code 10057934Term: Diabetic macular edema

• Registration Number: EUCTR2008-001064-37-DK
• Lead Sponsor: Fournier Laboratories Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-28
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

A subject will be eligible for study participation if he/she meets the following criteria:

1. Subject has voluntarily signed and dated an ICF, approved by an IEC, after the nature of the study has been explained and the subject has had the opportunity to ask questions and receive answers. The informed consent must be signed at the Pre-screening Visit, prior to any study-specific procedures.

2. Subject is = 30 years of age and either gender at the time of the Pre-screening Visit.

3. Subject has been diagnosed with T2DM for at least 6 months before the Pre-screening Visit. Any of the following will be considered to be sufficient evidence that diabetes is present:
a. Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes;
b. Current regular use of insulin for the treatment of diabetes;
c. Documented diabetes according to American Diabetes Association and/or World Health Organisation (WHO) criteria.

4. Subject is diagnosed with DME in at least one eye with any appropriate investigational method (i.e. slit lamp biomicroscopy or stereoscopic fundus photography) when laser photocoagulation can be safely postponed by at least 3 months in the investigator’s opinion.

5. Subject has at least one eligible eye on OCT assessment performed with standardized operation procedures and materials i.e. OCT3 (mapping software, version 4.0 or above from the Stratus® OCT, reference of standard OCT protocol of ETDRS study, 9 regions/subfields) and centrally read which is defined as thickness of = 300 µm in at least one of the 5 following zones: center zone, superior inner zone, nasal inner zone, inferior inner zone, temporal inner zone. Each eligible eye will be classified as:
a. With center involvement: center zone thickness = 250 µm;
b. Without center involvement: center zone thickness < 250 µm.

6. Subject has, in the opinion of the investigator, a life expectancy greater than one year at the Pre-screening Visit.

7. Subject has documented elevated TG levels (TG =89mg/dL [1.00 mmol/L]) at the Screening Visit or in the previous 3 months (in case of concomitant lipid-lowering treatment with a fibrate this criterion is verified after a minimum 4 week wash-out at visit 2).

8. If female, subject is either postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or of childbearing potential with negative results of a serum pregnancy test performed at the Screening Visit and she must agree to practice one of the following methods of birth control for the duration of the study:
a. total abstinence from sexual intercourse (minimum one complete menstrual cycle, prior to study drug administration);
b. a vasectomized partner;
c. hormonal contraceptives (oral, parenteral or transdermal) for at least 3 months prior to study drug administration;
d. intrauterine device (IUD); or
e. double-barrier method (condoms, contraceptive sponge, diaphragm or vaginal ring with spermicidal jellies or creams).

9. Subject is not breastfeeding at the Pre-screening Visit and at any time during the study.

10. Subject must be willing to participate in the study and to complete all the scheduled assessments.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 E

Exclusion Criteria

Any eye of the subject will be excluded in presence of any of the following criteria:

1. Has been treated with vitrectomy at any time, cataract extraction or scatter laser photocoagulation in the last 6 months or macular laser photocoagulation in the last 4 months.

2. Retinal thickening results from epiretinal membranes or vitreomacular traction.

3. Macular edema is considered to be due to a cause other than DME i.e. related to ocular surgery.

4. Eye is likely, in the investigator’s opinion, to receive scatter photocoagulation or photocoagulation for high risk PDR, capsulotomy, major ocular surgery including cataract extraction or intra-vitreal injection of anti inflammatory or/and anti VEGF agents in the next 6-12 months.

5. Definite glaucoma, but ocular hypertension alone will not be an exclusion criterion.

6. Has been previously enrolled in any study using intra-vitreal investigational product (e.g. steroids or antiVEGF) within 6 months of the Screening Visit.

7. Poor visual acuity: 20/800 (i.e. ETDRS visual acuity score 3 letters) or worse.

The subject will be excluded from the study if he/she meets any of the following criteria:

8. Unwilling or unable to consent to enter the study.

9. History of an allergic reaction or hypersensitivity to fenofibrate or ABT-335 /SLV348 or its inactive ingredients or known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.

10. Used any investigational drug within 8 weeks of the Screening Visit.

11. Uncontrolled T2DM defined as HbA1c of > 10%.

12. Systolic blood pressure (SBP) measurement of > 160 mmHg and/or a diastolic blood pressure (DBP) measurement of > 90 mmHg at the screening or baseline visits.

13. History of pancreatitis or gall bladder disease, but subjects with gall bladder disease who have previously undergone a cholecystectomy will be allowed to enroll.

14. History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.

15. History of gastric or duodenal ulcer within 3 months of the Pre-screening Visit.

16. Significant history of oncologic, hematologic, gastrointestinal, hepatic, or a neurological disorder (cerebrovascular disease, degenerative disease) that would limit study evaluation or participation.

17. Currently ongoing hepatitis B or hepatitis C.

18. Evidence of unstable or severe cardiovascular disease:
a. Myocardial infarction, coronary bypass surgery, or angioplasty within 3 months of the Pre-screening Visit;
b. Unstable angina pectoris or uncontrolled cardiac arrhythmias within 3 months prior to the Pre-screening Visit;
c. Severe peripheral artery disease as evidenced by critical limb ischemia within 3 months of the Pre-screening Visit;
d. Major peripheral artery surgery (e.g. femoral-popliteal revascularization, abdominal aortic aneurysm repair, etc.) within 3 months of the Pre-screening Visit.

19. Symptomatic heart failure (class III or IV of the New York Heart Association).

20. History of diagnosed hereditary or acquired myopathy.

21. Received a solid organ transplant.

22. Known to be human immunodeficiency virus positive.

23. History of mental instability, recreational drug or alcohol abuse or subject has been treated for severe psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study.

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Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified