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Fluocinolone Acetonide/Medidur

Phase 2

Age Related Macular Degeneration | Small molecule | Ophthalmology |ANI Pharmaceuticals, Inc.|Last Updated: Apr 7, 2014

Target and mechanism

ModalitySmall molecule

Also known as fluocinolone acetonide

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Fluocinolone Acetonide/Medidur · 1 trial · 1 indication

Phase 2 1
NCT00605423The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) PilotAge Related Macular Degeneration
COMPLETED6 Analytics
PHASE2COMPLETED
The MAP Study: Fluocinolone Acetonide (FA)/Medidur (TM) for Age Related Macular Degeneration (AMD) Pilot
Age Related Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean Change From Baseline in Visual Acuity
6 mos

Visual acuity is measured using ETDRS charts at 4 meters.

Secondary Endpoints

Number of Patients Developing Cataracts
6 mos
Change in IOP From Baseline
6 mos
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORDose 0.2 ug/day Medidur implant
2ACTIVE_COMPARATORDose 0.5 ug/day Medidur implant

Interventions

NameTypeDescription
Fluocinolone Acetonide/MedidurDRUG0.2 ug/day implant
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients 50 or greater * Treated with intraocular injections of Lucentis for at least 6 months and have reached a plateau, defined as 2 consecutive visits (4-6 weeks apart) with no improvement in VA (worse or within one line better) or center subfield thickening (worse or with...

Countries:United States
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Frequently asked questions about Fluocinolone Acetonide/Medidur

What is Fluocinolone Acetonide/Medidur used for?

Fluocinolone Acetonide/Medidur is an investigational small molecule being studied for Age Related Macular Degeneration and Diabetic Macular Edema. It is in Phase 2 clinical development for these ophthalmology indications. The drug is not approved and remains under investigation.

Who makes Fluocinolone Acetonide/Medidur?

ANI Pharmaceuticals, Inc. (ticker: ANIP) is developing Fluocinolone Acetonide/Medidur. The company is conducting clinical trials for the drug in the United States across multiple studies.

What phase is Fluocinolone Acetonide/Medidur in?

Fluocinolone Acetonide/Medidur is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for Age Related Macular Degeneration and Diabetic Macular Edema.

What clinical trials is Fluocinolone Acetonide/Medidur in?

Fluocinolone Acetonide/Medidur has completed three clinical trials. These include NCT00344968 and NCT00490815 for Diabetic Macular Edema, and NCT00605423 for Age Related Macular Degeneration. All trials were completed in the United States with a total enrollment of 1113 participants.

Is Fluocinolone Acetonide/Medidur the same as fluocinolone acetonide?

Yes, Fluocinolone Acetonide/Medidur is also known as fluocinolone acetonide. The drug is being developed by ANI Pharmaceuticals, Inc. under this alternative name in clinical trials for eye conditions.