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Macugen

Phase 2

Macular Edema Associated With Diabetes Mellitus | Small molecule | Ophthalmology |Pfizer, Inc.|Last Updated: Nov 16, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindSHAM_CONTROLLED
Total Trials1
Total Enrollment317

FDA Designations

No designations recorded

Clinical trial landscape

Macugen · 1 trial · 1 indication

Phase 2 1
NCT00605280A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.Macular Edema Associated With Diabetes Mellitus
COMPLETED317 Analytics
PHASE2COMPLETED
A Multi-Center Trial To Evaluate The Safety And Efficacy Of Pegaptanib Sodium(Macugen) Injected Into The Eye Every 6 Weeks For Up To 2 Years For Macular Swelling Associated With Diabetes, With An Open-Label Macugen Year Extension.
Macular Edema Associated With Diabetes MellitusUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Greater Than or Equal to ≥10 Letter (or 2 Line) Improvement in Vision at 1 Year
Baseline, Year 1

Refraction and best-corrected visual acuity (VA) measurements were performed using retro-illuminated, modified Ferris-Bailey Early Treatment Diabetic Retinopathy Study (ETDRS) charts

Secondary Endpoints

Number of Participants With a ≥ 10 Letter (or 2 Line) Improvement in Vision at 2 Years
Baseline, Year 2
Number of Participants With a ≥ 15 Letter Improvement in Vision at 1 Year
Baseline, Year 1
Number of Participants With a ≥ 15 Letter Improvement in Vision at 2 Years
Baseline, Year 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sham ControlSHAM_COMPARATOR -
MacugenEXPERIMENTAL -

Interventions

NameTypeDescription
Standard of CareDRUGClinicians decision to use optional laser therapy.
MacugenDRUGIntravitreal injection of Macugen 0.3mg/90ul every 6 weeks up to 2 years.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites73

Inclusion Criteria: * macular edema associated with diabetes * visual acuity between 20/50 and 20/200 Exclusion Criteria: * recent laser therapy in the eye * recent signs of uncontrolled diabetes * blood pressure worse than 160/100 * severe cardiac disease

Countries:United StatesAustraliaAustriaBrazilCanadaColombiaCzechiaDenmarkFranceGermanyGreeceIndiaItalyNetherlandsPortugalSouth AfricaSwitzerlandUnited Kingdom
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Frequently asked questions about Macugen

What is Macugen used for in Macular Edema Associated With Diabetes Mellitus?

Macugen is an investigational small molecule being studied for the treatment of Macular Edema Associated With Diabetes Mellitus. It is injected into the eye and is being evaluated for its safety and efficacy in reducing macular swelling associated with diabetes. The drug is currently in Phase 2 clinical development.

What does Macugen target?

Macugen is a small molecule designed for intravitreal injection to treat Macular Edema Associated With Diabetes Mellitus. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being studied for its ability to address macular swelling in diabetic patients.

Who makes Macugen?

Macugen is being developed by Pfizer, Inc., which trades under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's safety and efficacy for Macular Edema Associated With Diabetes Mellitus. Pfizer is responsible for the ongoing development of this investigational therapy.

What phase is Macugen in?

Macugen 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 the treatment of Macular Edema Associated With Diabetes Mellitus, with one completed Phase 2 trial involving 317 participants.

What clinical trials is Macugen in?

Macugen has one completed clinical trial, NCT00605280, a Phase 2 study evaluating the safety and efficacy of pegaptanib sodium (Macugen) injected into the eye every 6 weeks for up to 2 years for macular swelling associated with diabetes. The trial enrolled 317 participants across multiple countries.

Is Macugen the same as pegaptanib sodium?

Yes, Macugen is also known as pegaptanib sodium. The clinical trial NCT00605280 explicitly refers to pegaptanib sodium (Macugen) as the study drug. This alternative name is used in the trial title and is important for identifying the drug in medical literature and regulatory documents.