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Age Related Macular Degeneration (AMD)Phase 4PERSPECTIVESNCT00327470

An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD

A Phase 4 study testing Pegaptanib Sodium 0.3 mg in people with Age Related Macular Degeneration (AMD) and Macular Degeneration, run by Pfizer at 58 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Pegaptanib Sodium 0.3 mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
288 participants
Where
58 sitesin 15 countries
Study dates
Jul 2006to Aug 2009
Phase
Phase 4
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Evidence of neovascular AMD in at least one eye. In subjects with bilateral neovascular AMD, only one eye would be eligible for enrollment
  • Baseline visual acuity of greater than or equal to 20/320, or better than 25 ETDRS letters in the study eye

Who cannot join

  • Previous treatment for CNV secondary to AMD, including any prior PDT with verteporfin, thermal laser photocoagulation, external beam radiation or transpupillary thermotherapy to the study eye
  • Subjects having subfoveal fibrosis/ scar or atrophy representing > 25% of the total lesion size

Trial locations and contacts

58 sites in 15 countries.

58 sites in 15 countries

France7 sites

  • Pfizer Investigational Site

    Marseille, 13008

  • Pfizer Investigational Site

    Nancy, 54035

  • Pfizer Investigational Site

    Nantes, 44093

  • Pfizer Investigational Site

    Paris, 75015

  • Pfizer Investigational Site

    Paris, 75571

  • Pfizer Investigational Site

    Saint-Etienne, 42055

  • Pfizer Investigational Site

    Tours, 37044

Other trials in France

Canada6 sites

  • Pfizer Investigational Site

    Halifax, Nova Scotia, B3H 2Y9

  • Pfizer Investigational Site

    London, Ontario, N6A 4G5

  • Pfizer Investigational Site

    Montreal, Quebec, H3A 1A1

  • Pfizer Investigational Site

    Toronto, Ontario, M5T 2S8

  • Pfizer Investigational Site

    Victoria, British Columbia, V8R 1J8

  • Pfizer Investigational Site

    Victoria, British Columbia, V8V 4X3

Other trials in Canada

United Kingdom6 sites

  • Pfizer Investigational Site

    Aberdeen, Scotland, AB25 2ZN

  • Pfizer Investigational Site

    Belfast, BT12 6BA

  • Pfizer Investigational Site

    Bristol, BS1 2LX

  • Pfizer Investigational Site

    Edinburgh, Midlothian, EH3 9NA

  • Pfizer Investigational Site

    Leeds, LS9 7TF

  • Pfizer Investigational Site

    Southampton, SO16 6YD

Other trials in United Kingdom

Italy5 sites

  • Pfizer Investigational Site

    Ancona, 60020

  • Pfizer Investigational Site

    Bari, 70124

  • Pfizer Investigational Site

    Florence, 50134

  • Pfizer Investigational Site

    Milan, 20132

  • Pfizer Investigational Site

    Milan, 20157

Other trials in Italy

Austria4 sites

  • Pfizer Investigational Site

    Graz, A-8036

  • Pfizer Investigational Site

    Innsbruck, A-6020

  • Pfizer Investigational Site

    Vienna, A-1030

  • Pfizer Investigational Site

    Vienna, A-1180

Other trials in Austria

Czechia4 sites

  • Pfizer Investigational Site

    Olomouc, 775 20

  • Pfizer Investigational Site

    Prague, 128 08

  • Pfizer Investigational Site

    Prague, 140 00

  • Pfizer Investigational Site

    Prague, 169 02

Other trials in Czechia

Germany4 sites

  • Pfizer Investigational Site

    Dortmund, 44137

  • Pfizer Investigational Site

    Freiburg im Breisgau, 79106

  • Pfizer Investigational Site

    Halle, 06120

  • Pfizer Investigational Site

    Münster, 48145

Other trials in Germany

Poland4 sites

  • Pfizer Investigational Site

    Gdansk, 80-952

  • Pfizer Investigational Site

    Katowice, 40-952

  • Pfizer Investigational Site

    Poznan, 61-848

  • Pfizer Investigational Site

    Warsaw, 03-709

Other trials in Poland

Portugal4 sites

  • Pfizer Investigational Site

    Coimbra, 3000

  • Pfizer Investigational Site

    Lisbon, 1169-019

  • Pfizer Investigational Site

    Lisbon, 1169-0940

  • Pfizer Investigational Site

    Porto, 4200

Other trials in Portugal

Spain4 sites

  • Pfizer Investigational Site

    Alicante, Alicante, 03016

  • Pfizer Investigational Site

    Barcelona, Barcelona, 08025

  • Pfizer Investigational Site

    Santiago de Compostela, La Coruña, 15705

  • Pfizer Investigational Site

    Valencia, Valencia, 46014

Other trials in Spain

Belgium3 sites

  • Pfizer Investigational Site

    Brussels, 1020

  • Pfizer Investigational Site

    Brussels, 1070

  • Pfizer Investigational Site

    Liège, 4000

Other trials in Belgium

Turkey (Türkiye)3 sites

  • Pfizer Investigational Site

    Ankara, 06100

  • Pfizer Investigational Site

    Istanbul, 34098

  • Pfizer Investigational Site

    Istanbul, 34390

Other trials in Turkey (Türkiye)

Greece2 sites

  • Pfizer Investigational Site

    Athens, 115 27

  • Pfizer Investigational Site

    Athens, 155 62

Other trials in Greece

Denmark1 site

  • Pfizer Investigational Site

    Glostrup Municipality, 2600

Other trials in Denmark

Finland1 site

  • Pfizer Investigational Site

    Kuopio, Finlad, 70211

Other trials in Finland

About this study

Official title: A 102-Week, Open Label, Multicenter Trial To Investigate The Efficacy Of Macugen For The Preservation Of Visual Function In Subjects With Neovascular Age-Related Macular Degeneration (AMD) And To Assess The Benefit Of Treating Early Choroidal Neovascularization (CNV).

The purpose of this study is to determine the benefits of treating subjects with neovascular age-related macular degeneration (AMD) at an earlier stage of choroidal neovascularization (CNV) as compared to those with established CNV. Additionally, the study would like to determine the efficacy of Macugen in preserving visual function in those subjects having CNV secondary to neovascular AMD.

Read the detailed description

A decision was made by the sponsor (08 May 2009) to terminate this study early; the study had achieved the primary objective prior to termination. This study was not terminated due to safety reasons.

Being tested
Pegaptanib Sodium 0.3 mg
Keywords
neovascular age related macular degeneration, choroidal neovascularization
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

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

  • Pegaptanib Sodium 0.3 mgDrug

    Pegaptanib Sodium dosed every 6 weeks in affected eye.

Study groups in NCT00327470
Study groupRoleWhat they receive
Open LabelExperimentalNot described
Receives: Drug: Pegaptanib Sodium 0.3 mg

What is being measured

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

  1. Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions

    The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey Early Treatment of Diabetic Retinopathy Study (ETDRS) charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters from Baseline, gaining >=0 or >=15 letters from Baseline. The mean change in VA from Baseline at Week 54 was assessed.

    Measured: Baseline through Week 54

Secondary outcomes (6)

  1. Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions

    The investigator assessed the best-corrected VA obtained by a protocol refraction using the retroilluminated modified Ferris-Bailey ETDRS charts recorded at a 2-meter distance from the chart. Distance VA was expressed as an ETDRS score (number of letters correctly read): the proportion of subjects losing >=30 letters or <15 letters, gaining >=0 or >=15 letters. The mean changes in VA from Baseline/Week 102 and Week 52/102 were assessed.

    Measured: Baseline through Week 102, Week 54 through Week 102

  2. Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions

    Near VA was measured with the modified Bailey-Lovie near-word reading charts at a distance of 25 centimeters using a +3.50 reading addition worn over the protocol refraction providing the best-corrected distance VA. The reading charts test the smallest word size identifiable from 0.0 logarithmic of the minimum angle of resolution (logMAR) to 1.6 logMAR. logMAR is the logarithm of the minimum angle of resolution. The ideal is 0.0 and represents 20/20 Snellen acuity. logMAR values >0.00 indicate vision poorer than ideal and values <0.0 indicate vision greater than ideal.

    Measured: Baseline through Week 54, Baseline through Week 102

  3. Mean Change in Reading Speed

    For assessment of reading speed, subjects were asked to read a print steadily, without stopping or interruption, at a comfortable pace. On commencing reading, a timer was activated. The timer was stopped when the subject had finished reading all of the words on the chart or at 2 minutes, whichever was sooner. Only the total number of words read correctly was recorded. The time recorded for the reading speed test was the time required for the subject to finish reading all of the words on the chart in minutes and seconds (maximum 2 minutes).

    Measured: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

  4. Mean Change From Baseline in Contrast Sensitivity

    Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly.

    Measured: Baseline through Week 54, Baseline through Week 102

  5. Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score

    Subject reported vision-related functioning and Quality of Life (QoL) as measured using the 25 item NEI-VFQ-25. Items are grouped as the following - Composite: mean score items 1-25; General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. A positive change represents an increase in function/health, a negative change represents a decrease in function/health.

    Measured: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

  6. Mean Change in Euro QoL Questionnaire (EQ-5D) Score

    The EQ-5D is a validated, standardized QoL instrument assessing general health status based on the preference of a UK general population. It consists of two sections: a 100-point visual analog scale (VAS) and a descriptive system that contains five attributes (mobility, self-care, usual activities, pain or discomfort, and anxiety or depression) with three levels per attribute ("no problem", "some problems" and "extreme problems"). A subject's responses to these domains were mapped to a corresponding score of the EQ-5D index.

    Measured: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

Timeline

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

  1. First posted18 May 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionAug 2009
  4. Study completionAug 2009

Why it stopped: See termination reason in detailed description.

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00327470
Sponsor's protocol ID
A5751017
Acronym
PERSPECTIVES
Status last verified
Jan 2011
First submitted
17 May 2006
Last updated
4 Apr 2012
Data monitoring committee
No

Publications

  • Chakravarthy U, Staurenghi G, Kwok K, Tressler CS, Buggage R; PERSPECTIVES Study Group. Treating early choroidal neovascularisation with pegaptanib sodium in patients with neovascular age-related macular degeneration: findings of the PERSPECTIVES study. Br J Ophthalmol. 2012 Oct;96(10):1351-4. doi: 10.1136/bjophthalmol-2011-301444. Epub 2012 Aug 7. No abstract available.

    PubMed 22872673

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pegaptanib Sodium 0.3 mg in people with Age Related Macular Degeneration (AMD) and Macular Degeneration, run by Pfizer at 58 sites in 15 countries.

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 2 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: stopped early, as of the sponsor's last update on 4 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in France, Canada, United Kingdom, Italy, Austria and 10 more countries. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 17 Dec 2010). 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?

Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions (time frame: Baseline through Week 54). 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 NCT00327470, which also lists 1 linked publication.

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 4 Apr 2012.

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