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

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NCT00327470

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Graz, , A-8036 Austria
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age Related Macular Degeneration (AMD), Macular Degeneration, Choroidal Neovascularization (CNV)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00327470
Pfizer
Terminated
An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD

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An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD
A 102-Week, Open Label, Multicenter Trial To Investigate The Efficacy Of Macugen For The Preservation Of Visual Function In Subjects With Neovascular Age-Related Macular Degeneration (AMD) And To Assess The Benefit Of Treating Early Choroidal Neovascularization (CNV).
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.
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.
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Age Related Macular Degeneration (AMD)
  • Macular Degeneration
  • Choroidal Neovascularization (CNV)
Drug: Pegaptanib Sodium 0.3 mg
Pegaptanib Sodium dosed every 6 weeks in affected eye.
Experimental: Open Label
Intervention: Drug: Pegaptanib Sodium 0.3 mg
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. Epub 2012 Aug 7.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
288
August 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Greece,   Italy,   Poland,   Portugal,   Spain,   Turkey,   United Kingdom
Israel
 
NCT00327470
A5751017
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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1-800-718-1021

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