Status:

TERMINATED

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

Lead Sponsor:

Pfizer

Conditions:

Age Related Macular Degeneration (AMD)

Macular Degeneration

Eligibility:

All Genders

50+ years

Phase:

PHASE4

Brief Summary

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 compare...

Detailed Description

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.

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2009

Estimated Enrollment :

288 Patients enrolled

Trial Details

Trial ID

NCT00327470

Start Date

July 1 2006

End Date

August 1 2009

Last Update

April 4 2012

Active Locations (58)

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Page 1 of 15 (58 locations)

1

Pfizer Investigational Site

Graz, Austria, A-8036

2

Pfizer Investigational Site

Innsbruck, Austria, A-6020

3

Pfizer Investigational Site

Vienna, Austria, A-1030

4

Pfizer Investigational Site

Vienna, Austria, A-1180