A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD

NCT ID: NCT00354445

Last Updated: 2007-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Brief Summary

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The purpose of this study is to explore the safety and efficacy of Macugen given as maintenance therapy in patients who have had initial success with another AMD treatment. Patients must have 1, but not more than 3 prior treatments for Neovascular AMD.

Detailed Description

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Conditions

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Age-Related Macular Degeneration (AMD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pegaptanib sodium (Macugen)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subfoveal CNV secondary to AMD
* At least 1 but not more than 3 prior treatments for AMD

Exclusion Criteria

* Subfoveal scar or subfoveal atrophy
* Significant media opacities, including cataract, which might interfere with visual acuity
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Eyetech Pharmaceuticals

INDUSTRY

Sponsor Role lead

Locations

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Retina Research Institute of Texas, LLC

Abilene, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Macugen Information

Role: CONTACT

1-866-622-8436

Facility Contacts

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Macugen Information

Role: primary

866-622-8436

References

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Friberg TR, Tolentino M; LEVEL Study Group; Weber P, Patel S, Campbell S, Goldbaum M. Pegaptanib sodium as maintenance therapy in neovascular age-related macular degeneration: the LEVEL study. Br J Ophthalmol. 2010 Dec;94(12):1611-7. doi: 10.1136/bjo.2009.174946. Epub 2010 May 14.

Reference Type DERIVED
PMID: 20472746 (View on PubMed)

Other Identifiers

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EOP1023

Identifier Type: -

Identifier Source: org_study_id

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