NCT00239928

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2005

Typical duration for phase_2

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 4, 2011

Completed
Last Updated

May 12, 2011

Status Verified

May 1, 2011

Enrollment Period

3.2 years

First QC Date

October 13, 2005

Results QC Date

November 4, 2009

Last Update Submit

May 11, 2011

Conditions

Macular Degeneration

Keywords

Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Summary of Adverse Events

    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

    Week 54 (initiation of A5751015 study) up to Week 198

Secondary Outcomes (6)

  • Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point

    Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

  • Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point

    Weeks 54, every 18 weeks from Week 54 up to Week 198

  • Number of Responders

    Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

  • Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)

    Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

  • Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202)

    Week 0 (baseline), every 18 weeks from Week 54 up to Week 198

  • +1 more secondary outcomes

Study Arms (1)

EYE001

EXPERIMENTAL
Drug: pegaptanib sodium

Interventions

pegaptanib sodiumDRUG

1 drop per dosed eye per protocol.

EYE001

Eligibility Criteria

Age51 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • After completion of the preceding study (A5751010)

You may not qualify if:

  • Serious heart, kidney and/or liver disease
  • Diabetic retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Urayasu, Chiba, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Fukushima, Fukushima, Japan

Location

Pfizer Investigational Site

Maebashi, Gunma, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Kyoto, Kyoto, Japan

Location

Pfizer Investigational Site

Moriguchi, Osaka, Japan

Location

Pfizer Investigational Site

Suita, Osaka, Japan

Location

Pfizer Investigational Site

Ōtsu, Shiga, Japan

Location

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

Related Links

MeSH Terms

Conditions

Macular Degeneration

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Results Point of Contact

Title
Pfizer Clinical Trails.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

September 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 12, 2011

Results First Posted

May 4, 2011

Record last verified: 2011-05

Locations

JP(12)