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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00239928
First received: October 13, 2005
Last updated: May 11, 2011
Last verified: May 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   51 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00239928     History of Changes
Other Study ID Numbers: A5751015
Study First Received: October 13, 2005
Results First Received: November 4, 2009
Last Updated: May 11, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 22, 2014