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Macular DegenerationPhase 2NCT00239928

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

A Phase 2 study testing pegaptanib sodium in people with Macular Degeneration, run by Pfizer at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 51 years and older
Conditions the study is for
Macular Degeneration
What is being tested?
pegaptanib sodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
12 sitesJapan
Study dates
Sep 2005to Nov 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 51 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • After completion of the preceding study (A5751010)

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Pfizer Investigational Site

    Chiyoda-ku, Tokyo

  • Pfizer Investigational Site

    Fukuoka, Fukuoka

  • Pfizer Investigational Site

    Fukushima, Fukushima

  • Pfizer Investigational Site

    Kyoto, Kyoto

  • Pfizer Investigational Site

    Maebashi, Gunma

  • Pfizer Investigational Site

    Moriguchi, Osaka

  • Pfizer Investigational Site

    Nagoya, Aichi-ken

  • Pfizer Investigational Site

    Ōtsu, Shiga

  • Pfizer Investigational Site

    Sapporo, Hokkaido

  • Pfizer Investigational Site

    Shinjuku-ku, Tokyo

  • Pfizer Investigational Site

    Suita, Osaka

  • Pfizer Investigational Site

    Urayasu, Chiba

Other trials in Japan

About this study

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

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).

Being tested
pegaptanib sodium
Keywords
Long-Term Study For Pegaptanib Sodium In Patients With Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pegaptanib sodiumDrug

    1 drop per dosed eye per protocol.

Study groups in NCT00239928
Study groupRoleWhat they receive
EYE001ExperimentalNot described
Receives: Drug: pegaptanib sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (6)

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

    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.

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

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

    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.

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

  3. Number of Responders

    Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain.

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

  4. Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202)

    Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity.

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

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

    Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline.

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

  6. Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202)

    Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionNov 2008
  4. Study completionNov 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00239928
Sponsor's protocol ID
A5751015
Status last verified
May 2011
First submitted
13 Oct 2005
Last updated
12 May 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegaptanib sodium in people with Macular Degeneration, run by Pfizer at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Adverse Events (time frame: Week 54 (initiation of A5751015 study) up to Week 198). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00239928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2011.

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