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Choline Fenofibrate

Phase 2

Diabetic Macular Edema | Small molecule | Ophthalmology |Abbott Laboratories|Last Updated: Aug 26, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

Choline Fenofibrate · 1 trial · 1 indication

Phase 2 1
NCT00683176Effect of Choline Fenofibrate (SLV348) on Macular EdemaDiabetic Macular Edema
COMPLETED110 Analytics
PHASE2COMPLETED
Effect of Choline Fenofibrate (SLV348) on Macular Edema
Diabetic Macular EdemaUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Choline FenofibrateDRUG135 mg
PlaceboDRUGPlacebo
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Eligibility Criteria

Age Range30 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites21

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, ...

Countries:BulgariaCzechiaDenmarkGermanyHungaryItalyNetherlandsPolandSpainUnited Kingdom
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Frequently asked questions about Choline Fenofibrate

What is Choline Fenofibrate used for?

Choline Fenofibrate is an investigational small molecule being studied for the treatment of Diabetic Macular Edema, a condition that causes vision loss in people with diabetes. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Choline Fenofibrate?

Choline Fenofibrate is being developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. The drug is currently in Phase 2 clinical trials for Diabetic Macular Edema.

What phase is Choline Fenofibrate in?

Choline Fenofibrate is in Phase 2 clinical development. It is an investigational drug for Diabetic Macular Edema and has not received regulatory approval. One Phase 2 trial has been completed, and no active trials are currently listed.

What clinical trials is Choline Fenofibrate in?

Choline Fenofibrate has one completed Phase 2 clinical trial, identified as NCT00683176, titled "Effect of Choline Fenofibrate (SLV348) on Macular Edema." The trial enrolled 110 participants with Diabetic Macular Edema across multiple European countries, including Bulgaria, Czechia, Denmark, Germany, Hungary, Italy, Netherlands, Poland, Spain, and the United Kingdom.

Is Choline Fenofibrate the same as SLV348?

Yes, Choline Fenofibrate is also known as SLV348. The clinical trial NCT00683176, which studied the drug's effect on macular edema, refers to it as SLV348. This alternative name may appear in scientific literature and trial registries.