An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD
NCT00327470
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD | |||
Official Title ICMJE | 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). | |||
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 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. | |||
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. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: Pegaptanib Sodium 0.3 mg
Pegaptanib Sodium dosed every 6 weeks in affected eye. | |||
Study Arms ICMJE | Experimental: Open Label
Intervention: Drug: Pegaptanib Sodium 0.3 mg | |||
Publications * | 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. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 288 | |||
Original Enrollment ICMJE | 370 | |||
Actual Study Completion Date ICMJE | August 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 50 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Poland, Portugal, Spain, Turkey, United Kingdom | |||
Removed Location Countries | Israel | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00327470 | |||
Other Study ID Numbers ICMJE | A5751017 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | January 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |