An Open Label Trial to Investigate Macugen for the Preservation of Visual Function in Subjects With Neovascular AMD (PERSPECTIVES)
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|ClinicalTrials.gov Identifier: NCT00327470|
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : May 18, 2006
Results First Posted : December 17, 2010
Last Update Posted : April 4, 2012
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration (AMD) Macular Degeneration Choroidal Neovascularization (CNV)||Drug: Pegaptanib Sodium 0.3 mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||288 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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).|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
|Experimental: Open Label||
Drug: Pegaptanib Sodium 0.3 mg
Pegaptanib Sodium dosed every 6 weeks in affected eye.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327470
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|