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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00327470
First received: May 17, 2006
Last updated: April 2, 2012
Last verified: January 2011
  Purpose

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.


Condition Intervention Phase
Age Related Macular Degeneration (AMD)
Macular Degeneration
Choroidal Neovascularization (CNV)
Drug: Pegaptanib Sodium 0.3 mg
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Mean Change in Reading Speed [ Time Frame: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102 ] [ Designated as safety issue: No ]
    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).

  • Mean Change From Baseline in Contrast Sensitivity [ Time Frame: Baseline through Week 54, Baseline through Week 102 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 288
Study Start Date: July 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open Label Drug: Pegaptanib Sodium 0.3 mg
Pegaptanib Sodium dosed every 6 weeks in affected eye.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00327470

  Show 58 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00327470     History of Changes
Other Study ID Numbers: A5751017
Study First Received: May 17, 2006
Results First Received: April 13, 2010
Last Updated: April 2, 2012
Health Authority: Turkey:Ministry of Health Central Ethics Committee

Keywords provided by Pfizer:
neovascular age related macular degeneration
choroidal neovascularization

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 22, 2014