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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00239928
First Posted: October 17, 2005
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
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).

Condition Intervention Phase
Macular Degeneration Drug: pegaptanib sodium Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration (Extension Study From A5751010)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 61
Study Start Date: September 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EYE001 Drug: pegaptanib sodium
1 drop per dosed eye per protocol.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   51 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • After completion of the preceding study (A5751010)

Exclusion Criteria:

  • Serious heart, kidney and/or liver disease
  • Diabetic retinopathy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00239928


Locations
Japan
Pfizer Investigational Site
Nagoya, Aichi, Japan
Pfizer Investigational Site
Urayasu, Chiba, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka-ken, Japan
Pfizer Investigational Site
Maebashi, Gunma, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Moriguchi, Osaka, Japan
Pfizer Investigational Site
Suita, Osaka, Japan
Pfizer Investigational Site
Otsu, Shiga, Japan
Pfizer Investigational Site
Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site
Shinjuku-ku, Tokyo, Japan
Pfizer Investigational Site
Fukushima, Japan
Pfizer Investigational Site
Kyoto, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00239928     History of Changes
Other Study ID Numbers: A5751015
First Submitted: October 13, 2005
First Posted: October 17, 2005
Results First Submitted: November 4, 2009
Results First Posted: May 4, 2011
Last Update Posted: May 12, 2011
Last Verified: May 2011

Keywords provided by Pfizer:
Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes