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

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: Terminated
• Conditions: Macular Degeneration; Age Related Macular Degeneration (AMD); Choroidal Neovascularization (CNV)
• Intervention / Treatment: Drug: Pegaptanib Sodium 0.3 mg

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: Interventional
• Enrollment (Actual): 288
• Phase: Phase 4

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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	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

Outcome Measure	Measure Description	Time Frame
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.	Baseline through Week 102, Week 54 through Week 102
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.	Baseline through Week 54, Baseline through Week 102
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).	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102
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.	Baseline through Week 54, Baseline through Week 102
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.	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102
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.	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General 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.

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: May 17, 2006
• First Submitted That Met QC Criteria: May 17, 2006
• First Posted (Estimate): May 18, 2006

Study Record Updates

• Last Update Posted (Estimate): April 4, 2012
• Last Update Submitted That Met QC Criteria: April 2, 2012
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Keywords: choroidal neovascularization; neovascular age related macular degeneration
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
• Other Study ID Numbers: A5751017