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1, 2 dithiolane 3 valeric acid

Phase 3

Diabetes Mellitus | Small molecule | Metabolic |Bausch + Lomb Corporation|Last Updated: Sep 24, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment520

FDA Designations

No designations recorded

Clinical trial landscape

1, 2 dithiolane 3 valeric acid · 1 trial · 2 indications

Phase 3 1
NCT01208948Clinical Trial on Alpha Lipoic Acid in Diabetic Macular EdemaDiabetes Mellitus
COMPLETED520 Analytics
PHASE3COMPLETED
Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema
Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

occurrence of clinically significant macular edema (CSME) within a follow-up period of 2 years
two years

Secondary Endpoints

The time to CSME development
two years
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Alpha lipoic acid 600 mgACTIVE_COMPARATOR -
placebo pillPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
1,2 dithiolane 3 valeric acidDRUG600 mg alpha lipoic acid per day
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Eligibility Criteria

Age Range45 Years to 68 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Diabetes type II, mild non proliferative diabetic retinopathy, * Microalbuminuria \> 30 mg/L Exclusion Criteria: Ophthalmic exclusion criteria * severe non-proliferative or proliferative diabetic retinopathy * Macular edema * Eye diseases interfering with the examinations o...

Countries:Germany
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Frequently asked questions about 1, 2 dithiolane 3 valeric acid

What is 1,2 dithiolane 3 valeric acid used for?

1,2 dithiolane 3 valeric acid is being studied for use in diabetes mellitus, specifically for diabetic macular edema, a complication of diabetes that affects the eyes. It is a small molecule being developed as a potential treatment for this condition.

What does 1,2 dithiolane 3 valeric acid target?

The specific molecular target of 1,2 dithiolane 3 valeric acid is not disclosed in available information. It is a small molecule being investigated for its potential effects in diabetic macular edema, but its mechanism of action has not been publicly detailed.

Who makes 1,2 dithiolane 3 valeric acid?

1,2 dithiolane 3 valeric acid is being developed by Bausch + Lomb Corporation, a company traded on the stock exchange under the ticker symbol BLCO. The company is conducting clinical research on this compound for diabetic macular edema.

What phase is 1,2 dithiolane 3 valeric acid in?

1,2 dithiolane 3 valeric acid is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is 1,2 dithiolane 3 valeric acid in?

1,2 dithiolane 3 valeric acid has been studied in a Phase 3 clinical trial registered as NCT01208948, titled "Clinical Trial on Alpha Lipoic Acid in Diabetic Macular Edema." This completed trial enrolled 520 participants with diabetes mellitus and macular edema in Germany.

Is 1,2 dithiolane 3 valeric acid the same as alpha lipoic acid?

1,2 dithiolane 3 valeric acid is also known as alpha lipoic acid. The clinical trial NCT01208948 refers to the compound as alpha lipoic acid, indicating that these names refer to the same substance being studied for diabetic macular edema.