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Trial record 1 of 1 for:    NCT00239928
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Clinical Study Of Pegaptanib Sodium (EYE001) For Wet-Type Age-Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT00239928
Recruitment Status : Completed
First Posted : October 17, 2005
Results First Posted : May 4, 2011
Last Update Posted : May 12, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE October 13, 2005
First Posted Date  ICMJE October 17, 2005
Results First Submitted Date  ICMJE November 4, 2009
Results First Posted Date  ICMJE May 4, 2011
Last Update Posted Date May 12, 2011
Study Start Date  ICMJE September 2005
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2011)
Summary of Adverse Events [ Time Frame: Week 54 (initiation of A5751015 study) up to Week 198 ]
Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
Adverse events
Change History Complete list of historical versions of study NCT00239928 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2011)
  • Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point [ Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 ]
    Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
  • Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point [ Time Frame: Weeks 54, every 18 weeks from Week 54 up to Week 198 ]
    Value at each observation time point minus value at Week 54 (initiation of current study). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0.
  • Number of Responders [ Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 ]
    Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.
  • Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) [ Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 ]
    Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.
  • Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) [ Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 ]
    Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.
  • Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) [ Time Frame: Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 ]
    Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2005)
Serious adverse events Laboratory test abnormalities Blood pressure/pulse rate IOP Visual acuity (using ETDRS chart) in a long term treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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