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

May 17, 2006
April 2, 2012
July 2006
August 2009   (final data collection date for 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 ] [ 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.
The mean change in distance visual acuity from baseline to week 54 in subjects with early and established CNV lesions by assessing the best corrected visual acuity as measured by ETDRS score
Complete list of historical versions of study NCT00327470 on ClinicalTrials.gov Archive Site
  • 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.
  • 1) Mean change in distance visual acuity from baseline to 102 weeks and from
  • Week 54 to Week 102 in subjects with early and established CNV lesions. 2) The mean change in near visual acuity from baseline in subjects with early
  • and established CNV lesions at Weeks 54 and 102; the mean change in near visual
  • acuity from Week 54 to Week 102. 3) The mean change in reading speed in subjects with early and established CNV
  • lesions from baseline at Weeks 54 and 102 and from Week 54 to Week 102. 4) The mean change in contrast sensitivity in subjects with early and
  • established CNV lesions from baseline at Week 54 and Week 102. 5) The mean change in NEI-VFQ composite score and EQ5D score from baseline
  • in subjects with early and established CNV lesions at Weeks 54 and 102.
Not Provided
Not Provided
 
An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD
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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Age Related Macular Degeneration (AMD)
  • Macular Degeneration
  • Choroidal Neovascularization (CNV)
Drug: Pegaptanib Sodium 0.3 mg
Pegaptanib Sodium dosed every 6 weeks in affected eye.
Experimental: Open Label
Intervention: Drug: Pegaptanib Sodium 0.3 mg
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. Epub 2012 Aug 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
288
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Austria,   Belgium,   Canada,   United Kingdom,   Denmark,   Finland,   France,   Germany,   Greece,   Italy,   Poland,   Portugal,   Spain,   Turkey
 
NCT00327470
A5751017
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP