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

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NCT00327470

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Study Location
Pfizer Investigational Site
Graz, , A-8036, Austria
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Contact
1-800-718-1021
[email protected]
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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

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Age Related Macular Degeneration (AMD), Macular Degeneration, Choroidal Neovascularization (CNV)An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD NCT00327470
  1. Graz,
  2. Innsbruck,
  3. Wien,
  4. Wien,
  5. Bruxelles,
  6. Bruxelles,
  7. Liege,
  8. Victoria, British Columbia
  9. Victoria, British Columbia
  10. Halifax, Nova Scotia
  11. London, Ontario
  12. Toronto, Ontario
  13. Montreal, Quebec
  14. Olomouc,
  15. Praha 2,
  16. Praha 4,
  17. Praha 6,
  18. Glostrup,
  19. Kuopio, Finlad
  20. Marseille,
  21. Nancy Cedex,
  22. Nantes Cedex 1,
  23. Paris Cedex 12,
  24. Paris,
  25. St. Etienne Cedex 2,
  26. Tours cedex 1,
  27. Dortmund,
  28. Freiburg,
  29. Halle,
  30. Muenster,
  31. Athens,
  32. Athens,
  33. Ancona,
  34. Bari,
  35. Firenze,
  36. Milano,
  37. Milano,
  38. Gdansk,
  39. Katowice,
  40. Poznan,
  41. Warszawa,
  42. Coimbra,
  43. Lisboa,
  44. Lisboa,
  45. Porto,
  46. Santiago de Compostela, La Coruña
  47. Alicante,
  48. Barcelona,
  49. Valencia,
  50. Ankara,
  51. Istanbul,
  52. Istanbul,
  53. Edinburgh, Midlothian
  54. Aberdeen, Scotland
  55. Belfast,
  56. Bristol,
  57. Leeds,
  58. Southampton,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • Age Related Macular Degeneration (AMD)
  • Macular Degeneration
  • Choroidal Neovascularization (CNV)
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
 (submitted: December 30, 2010)		288
Original Enrollment  ICMJE
 (submitted: May 17, 2006)		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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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