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

History of Changes

Results First Received: April 13, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Age Related Macular Degeneration (AMD) Macular Degeneration Choroidal Neovascularization (CNV)
Intervention:	Drug: Pegaptanib Sodium 0.3 mg

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Early Age-related Macular Degeneration (AMD)	Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Description

Early Age-related Macular Degeneration (AMD)

Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Established AMD

Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Participant Flow: Overall Study

	Early Age-related Macular Degeneration (AMD)	Established AMD
STARTED	107	181
Treated	107	179
COMPLETED	78	118
NOT COMPLETED	29	63
Randomized, but not treated	0	2
Adverse Event	9	14
Lack of Efficacy	7	19
Unknown	5	9
Lost to Follow-up	1	3
Withdrawal by Subject	6	12
Death	1	4

Baseline Characteristics

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Reporting Groups

	Description
Early AMD	Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
Established AMD	Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
Total	Total of all reporting groups

Baseline Measures

	Early AMD	Established AMD	Total
Number of Participants [units: participants]	107	179	286
Age, Customized [units: Participants]
45 through 64 years	12	24	36
>= 65 years	95	155	250
Gender [units: Participants]
Female	59	108	167
Male	48	71	119

Outcome Measures

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1. Primary:

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 ]

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2. Secondary:

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 ]

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3. Secondary:

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 ]

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4. Secondary:

Mean Change in Reading Speed [ Time Frame: Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102 ]

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5. Secondary:

Mean Change From Baseline in Contrast Sensitivity [ Time Frame: Baseline through Week 54, Baseline through Week 102 ]

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6. Secondary:

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 ]

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Measure Type	Secondary
Measure Title	Mean Change in National Eye Institute – Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score
Measure Description	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.
Time Frame	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
MITT. Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed. n=number of subjects with evaluable data.

Reporting Groups

Description

Early AMD

Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).

Established AMD

Measured Values

	Early AMD	Established AMD
Number of Participants Analyzed [units: participants]	107	178
Mean Change in National Eye Institute – Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score [units: Scores on a scale] Mean ± Standard Deviation
Baseline through Week 54 (n=90, n=146)	-1.54 ± 12.946	-1.03 ± 13.264
Baseline through Week 102 (n=67, n=111)	-4.57 ± 14.410	-1.65 ± 12.569
Week 54 through Week 102 (n=64, n=115)	-2.74 ± 9.655	-2.48 ± 9.473

No statistical analysis provided for Mean Change in National Eye Institute – Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score

7. Secondary:

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 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided by Pfizer

Publications automatically indexed to this study:

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.

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

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