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

April 2, 2012 updated by: Pfizer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
288

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, A-8036
        • Pfizer Investigational Site
      • Innsbruck, Austria, A-6020
        • Pfizer Investigational Site
      • Wien, Austria, A-1030
        • Pfizer Investigational Site
      • Wien, Austria, A-1180
        • Pfizer Investigational Site
  • Belgium
      • Bruxelles, Belgium, 1070
        • Pfizer Investigational Site
      • Bruxelles, Belgium, 1020
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 1J8
        • Pfizer Investigational Site
      • Victoria, British Columbia, Canada, V8V 4X3
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5T 2S8
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Pfizer Investigational Site
  • Czech Republic
      • Olomouc, Czech Republic, 775 20
        • Pfizer Investigational Site
      • Praha 2, Czech Republic, 128 08
        • Pfizer Investigational Site
      • Praha 4, Czech Republic, 140 00
        • Pfizer Investigational Site
      • Praha 6, Czech Republic, 169 02
        • Pfizer Investigational Site
  • Denmark
      • Glostrup, Denmark, 2600
        • Pfizer Investigational Site
  • Finland
    • Finlad
      • Kuopio, Finlad, Finland, 70211
        • Pfizer Investigational Site
  • France
      • Marseille, France, 13008
        • Pfizer Investigational Site
      • Nancy Cedex, France, 54035
        • Pfizer Investigational Site
      • Nantes Cedex 1, France, 44093
        • Pfizer Investigational Site
      • Paris, France, 75015
        • Pfizer Investigational Site
      • Paris Cedex 12, France, 75571
        • Pfizer Investigational Site
      • St. Etienne Cedex 2, France, 42055
        • Pfizer Investigational Site
      • Tours cedex 1, France, 37044
        • Pfizer Investigational Site
  • Germany
      • Dortmund, Germany, 44137
        • Pfizer Investigational Site
      • Freiburg, Germany, 79106
        • Pfizer Investigational Site
      • Halle, Germany, 06120
        • Pfizer Investigational Site
      • Muenster, Germany, 48145
        • Pfizer Investigational Site
  • Greece
      • Athens, Greece, 115 27
        • Pfizer Investigational Site
      • Athens, Greece, 155 62
        • Pfizer Investigational Site
  • Italy
      • Ancona, Italy, 60020
        • Pfizer Investigational Site
      • Bari, Italy, 70124
        • Pfizer Investigational Site
      • Firenze, Italy, 50134
        • Pfizer Investigational Site
      • Milano, Italy, 20132
        • Pfizer Investigational Site
      • Milano, Italy, 20157
        • Pfizer Investigational Site
  • Poland
      • Gdansk, Poland, 80-952
        • Pfizer Investigational Site
      • Katowice, Poland, 40-952
        • Pfizer Investigational Site
      • Poznan, Poland, 61-848
        • Pfizer Investigational Site
      • Warszawa, Poland, 03-709
        • Pfizer Investigational Site
  • Portugal
      • Coimbra, Portugal, 3000
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1169-019
        • Pfizer Investigational Site
      • Lisboa, Portugal, 1169-0940
        • Pfizer Investigational Site
      • Porto, Portugal, 4200
        • Pfizer Investigational Site
  • Spain
      • Alicante, Spain, 03016
        • Pfizer Investigational Site
      • Barcelona, Spain, 08025
        • Pfizer Investigational Site
      • Valencia, Spain, 46014
        • Pfizer Investigational Site
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15705
        • Pfizer Investigational Site
  • Turkey
      • Ankara, Turkey, 06100
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34390
        • Pfizer Investigational Site
      • Istanbul, Turkey, 34098
        • Pfizer Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
        • Pfizer Investigational Site
      • Bristol, United Kingdom, BS1 2LX
        • Pfizer Investigational Site
      • Leeds, United Kingdom, LS9 7TF
        • Pfizer Investigational Site
      • Southampton, United Kingdom, SO16 6YD
        • Pfizer Investigational Site
    • Midlothian
      • Edinburgh, Midlothian, United Kingdom, EH3 9NA
        • Pfizer Investigational Site
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Open Label
Drug: Pegaptanib Sodium 0.3 mg
Pegaptanib Sodium dosed every 6 weeks in affected eye.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Baseline through Week 54

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions
Time Frame: Baseline through Week 102, Week 54 through Week 102
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.
Baseline through Week 102, Week 54 through Week 102
Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions
Time Frame: Baseline through Week 54, Baseline through Week 102
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.
Baseline through Week 54, Baseline through Week 102
Mean Change in Reading Speed
Time Frame: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102
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).
Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102
Mean Change From Baseline in Contrast Sensitivity
Time Frame: Baseline through Week 54, Baseline through Week 102
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.
Baseline through Week 54, Baseline through Week 102
Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score
Time Frame: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102
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.
Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102
Mean Change in Euro QoL Questionnaire (EQ-5D) Score
Time Frame: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102
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.
Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 17, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 2, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A5751017

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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