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Completed

NCT Number: NCT00239928

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

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).

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

51 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • After completion of the preceding study (A5751010)

Exclusion criteria

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

Treatment and study plan

pegaptanib sodium

Drug

1 drop per dosed eye per protocol.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration (Extension Study From A5751010)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 17, 2005
Registry last updated
May 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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