Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration

NCT00239928

Last updated date
Study Location
Pfizer Investigational Site
Nagoya, Aichi, , Japan
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
51 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- After completion of the preceding study (A5751010)

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


- Serious heart, kidney and/or liver disease


- Diabetic retinopathy

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  25. PARIS Cedex 19,
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  6. Sapporo, Hokkaido
  7. Kida-gun, Kagawa
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  9. Suita, Osaka
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Advanced Information
Descriptive Information
Brief Title  ICMJE Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration
Official Title  ICMJE Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration (Extension Study From A5751010)
Brief Summary This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Macular Degeneration
Intervention  ICMJE Drug: pegaptanib sodium
1 drop per dosed eye per protocol.
Study Arms  ICMJE Experimental: EYE001
Intervention: Drug: pegaptanib sodium
Publications * Not Provided

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2008)
61
Original Enrollment  ICMJE
 (submitted: October 13, 2005)
70
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • After completion of the preceding study (A5751010)

Exclusion Criteria:

  • Serious heart, kidney and/or liver disease
  • Diabetic retinopathy
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 51 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00239928
Other Study ID Numbers  ICMJE A5751015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer Inc
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP