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An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD

NCT ID: NCT00327470

Last Updated: 2012-04-04

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

288 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-08-31

Brief Summary

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The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.

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Detailed Description

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A decision was made by the sponsor (08 May 2009) to terminate this study early; the study had achieved the primary objective prior to termination. This study was not terminated due to safety reasons.

Conditions

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Age Related Macular Degeneration (AMD) Macular Degeneration Choroidal Neovascularization (CNV)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label

Group Type EXPERIMENTAL

Pegaptanib Sodium 0.3 mg

Intervention Type DRUG

Pegaptanib Sodium dosed every 6 weeks in affected eye.

Interventions

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Pegaptanib Sodium 0.3 mg

Pegaptanib Sodium dosed every 6 weeks in affected eye.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Evidence of neovascular AMD in at least one eye. In subjects with bilateral neovascular AMD, only one eye would be eligible for enrollment
* Baseline visual acuity of greater than or equal to 20/320, or better than 25 ETDRS letters in the study eye

Exclusion Criteria

* Previous treatment for CNV secondary to AMD, including any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye
* Subjects having subfoveal fibrosis/ scar or atrophy representing \> 25% of the total lesion size
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Graz, , Austria

Site Status

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Innsbruck, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Brussels, , Belgium

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Brussels, , Belgium

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Liège, , Belgium

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Victoria, British Columbia, Canada

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Victoria, British Columbia, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Olomouc, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Glostrup Municipality, , Denmark

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Kuopio, Finlad, Finland

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Marseille, , France

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Nancy, , France

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Nantes, , France

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Paris, , France

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Paris, , France

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Saint-Etienne, , France

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Tours, , France

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Dortmund, , Germany

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Freiburg im Breisgau, , Germany

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Halle, , Germany

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Münster, , Germany

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Athens, , Greece

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Athens, , Greece

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Ancona, , Italy

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Bari, , Italy

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Florence, , Italy

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Milan, , Italy

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Milan, , Italy

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Gdansk, , Poland

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Katowice, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Alicante, Alicante, Spain

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Barcelona, Barcelona, Spain

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Santiago de Compostela, La Coruña, Spain

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Valencia, Valencia, Spain

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Edinburgh, Midlothian, United Kingdom

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Aberdeen, Scotland, United Kingdom

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Belfast, , United Kingdom

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Bristol, , United Kingdom

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Leeds, , United Kingdom

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Pfizer Investigational Site

Southampton, , United Kingdom

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Countries

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Austria Belgium Canada Czechia Denmark Finland France Germany Greece Italy Poland Portugal Spain Turkey (Türkiye) United Kingdom

References

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Chakravarthy U, Staurenghi G, Kwok K, Tressler CS, Buggage R; PERSPECTIVES Study Group. Treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration: findings of the PERSPECTIVES study. Br J Ophthalmol. 2012 Oct;96(10):1351-4. doi: 10.1136/bjophthalmol-2011-301444. Epub 2012 Aug 7. No abstract available.

Reference Type DERIVED
PMID: 22872673 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5751017&StudyName=An%20Open%20Label%20Trial%20to%20Investigate%20Macugen%20for%20the%20Preservation%20of%20Visual%20Function%20in%20subjects%20with%20Neovascular%20AMD

To obtain contact information for a study center near you, click here.

Other Identifiers

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A5751017

Identifier Type: -

Identifier Source: org_study_id

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