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

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00327470
• Collaborator: (none)
• Enrollment: 288
• Locations: 58
• Arm: 1
• Duration (Months): 37
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration (AMD); Macular Degeneration; Choroidal Neovascularization (CNV)	Drug: Pegaptanib Sodium 0.3 mg	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 288 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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).
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open Label	Drug: Pegaptanib Sodium 0.3 mg; Pegaptanib Sodium dosed every 6 weeks in affected eye.

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions [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.

Secondary Outcome Measures

1. Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions [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.

2. Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions [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.

3. Mean Change in Reading Speed [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).

4. Mean Change From Baseline in Contrast Sensitivity [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.

5. Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score [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.

6. Mean Change in Euro QoL Questionnaire (EQ-5D) Score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Graz		Austria	A-8036
2	Pfizer Investigational Site	Innsbruck		Austria	A-6020
3	Pfizer Investigational Site	Wien		Austria	A-1030
4	Pfizer Investigational Site	Wien		Austria	A-1180
5	Pfizer Investigational Site	Bruxelles		Belgium	1020
6	Pfizer Investigational Site	Bruxelles		Belgium	1070
7	Pfizer Investigational Site	Liege		Belgium	4000
8	Pfizer Investigational Site	Victoria	British Columbia	Canada	V8R 1J8
9	Pfizer Investigational Site	Victoria	British Columbia	Canada	V8V 4X3
10	Pfizer Investigational Site	Halifax	Nova Scotia	Canada	B3H 2Y9
11	Pfizer Investigational Site	London	Ontario	Canada	N6A 4G5
12	Pfizer Investigational Site	Toronto	Ontario	Canada	M5T 2S8
13	Pfizer Investigational Site	Montreal	Quebec	Canada	H3A 1A1
14	Pfizer Investigational Site	Olomouc		Czech Republic	775 20
15	Pfizer Investigational Site	Praha 2		Czech Republic	128 08
16	Pfizer Investigational Site	Praha 4		Czech Republic	140 00
17	Pfizer Investigational Site	Praha 6		Czech Republic	169 02
18	Pfizer Investigational Site	Glostrup		Denmark	2600
19	Pfizer Investigational Site	Kuopio	Finlad	Finland	70211
20	Pfizer Investigational Site	Marseille		France	13008
21	Pfizer Investigational Site	Nancy Cedex		France	54035
22	Pfizer Investigational Site	Nantes Cedex 1		France	44093
23	Pfizer Investigational Site	Paris Cedex 12		France	75571
24	Pfizer Investigational Site	Paris		France	75015
25	Pfizer Investigational Site	St. Etienne Cedex 2		France	42055
26	Pfizer Investigational Site	Tours cedex 1		France	37044
27	Pfizer Investigational Site	Dortmund		Germany	44137
28	Pfizer Investigational Site	Freiburg		Germany	79106
29	Pfizer Investigational Site	Halle		Germany	06120
30	Pfizer Investigational Site	Muenster		Germany	48145
31	Pfizer Investigational Site	Athens		Greece	115 27
32	Pfizer Investigational Site	Athens		Greece	155 62
33	Pfizer Investigational Site	Ancona		Italy	60020
34	Pfizer Investigational Site	Bari		Italy	70124
35	Pfizer Investigational Site	Firenze		Italy	50134
36	Pfizer Investigational Site	Milano		Italy	20132
37	Pfizer Investigational Site	Milano		Italy	20157
38	Pfizer Investigational Site	Gdansk		Poland	80-952
39	Pfizer Investigational Site	Katowice		Poland	40-952
40	Pfizer Investigational Site	Poznan		Poland	61-848
41	Pfizer Investigational Site	Warszawa		Poland	03-709
42	Pfizer Investigational Site	Coimbra		Portugal	3000
43	Pfizer Investigational Site	Lisboa		Portugal	1169-019
44	Pfizer Investigational Site	Lisboa		Portugal	1169-0940
45	Pfizer Investigational Site	Porto		Portugal	4200
46	Pfizer Investigational Site	Santiago de Compostela	La Coruña	Spain	15705
47	Pfizer Investigational Site	Alicante		Spain	03016
48	Pfizer Investigational Site	Barcelona		Spain	08025
49	Pfizer Investigational Site	Valencia		Spain	46014
50	Pfizer Investigational Site	Ankara		Turkey	06100
51	Pfizer Investigational Site	Istanbul		Turkey	34098
52	Pfizer Investigational Site	Istanbul		Turkey	34390
53	Pfizer Investigational Site	Edinburgh	Midlothian	United Kingdom	EH3 9NA
54	Pfizer Investigational Site	Aberdeen	Scotland	United Kingdom	AB25 2ZN
55	Pfizer Investigational Site	Belfast		United Kingdom	BT12 6BA
56	Pfizer Investigational Site	Bristol		United Kingdom	BS1 2LX
57	Pfizer Investigational Site	Leeds		United Kingdom	LS9 7TF
58	Pfizer Investigational Site	Southampton		United Kingdom	SO16 6YD

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00327470
• Other Study ID Numbers: A5751017
• First Posted: May 18, 2006
• Last Update Posted: Apr 4, 2012
• Last Verified: Jan 1, 2011

• Keywords provided by Pfizer: neovascular age related macular degeneration; choroidal neovascularization
• Additional relevant MeSH terms: Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic

Study Results

Participant Flow

Arm/Group Title	Early Age-related Macular Degeneration (AMD)	Established AMD
Arm/Group Description	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).	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).
Period Title: Overall Study
STARTED	107	181
Treated	107	179
COMPLETED	78	118
NOT COMPLETED	29	63

Baseline Characteristics

Arm/Group Title	Early AMD	Established AMD	Total
Arm/Group Description	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).	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 of all reporting groups
Overall Participants	107	179	286
Age, Customized (Number) [Number]
45 through 64 years	12 11.2%	24 13.4%	36 12.6%
>= 65 years	95 88.8%	155 86.6%	250 87.4%
Sex: Female, Male (Count of Participants)
Female	59 55.1%	108 60.3%	167 58.4%
Male	48 44.9%	71 39.7%	119 41.6%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline Through Week 54 in Distance Visual Acuity (VA) in Subjects With Early and Established CNV Lesions
Description	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.
Time Frame	Baseline through Week 54

Outcome Measure Data

Analysis Population Description

The modified intent-to-treat (MITT) population included all subjects in the safety population who had a Baseline distance VA measurement and at least 1 post-Baseline VA measurement. Last observation carried forward (LOCF). Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.

Arm/Group Title	Early AMD	Established AMD
Arm/Group Description	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).	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).
Measure Participants	107	178
Mean (Standard Deviation) [Scores on a scale]	-4.30 (14.57)	-5.51 (15.08)

2. Secondary Outcome

Title	Mean Change From Baseline in Distance VA in Subjects With Early and Established CNV Lesions
Description	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.
Time Frame	Baseline through Week 102, Week 54 through Week 102

Outcome Measure Data

Analysis Population Description

MITT LOCF; Note: the number of participants analyzed refers to the number of subjects who had data that could be analyzed.

Arm/Group Title	Early AMD	Established AMD
Arm/Group Description	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).	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).
Measure Participants	107	178
Baseline through Week 102	-7.91 (16.14)	-8.95 (17.34)
Week 54 through Week 102	-3.61 (9.83)	-3.44 (9.81)

3. Secondary Outcome

Title	Mean Change From Baseline in Near VA in Subjects With Early and Established CNV Lesions
Description	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.
Time Frame	Baseline through Week 54, Baseline through Week 102

Outcome Measure Data

Analysis Population Description

MITT LOCF. 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.

Arm/Group Title	Early AMD	Established AMD
Arm/Group Description	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).	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).
Measure Participants	107	178
Baseline through Week 54 (n=104, n=172)	0.10 (0.27)	0.15 (0.32)
Baseline through Week 102 (n=105, n=172)	0.19 (0.34)	0.22 (0.36)

4. Secondary Outcome

Title	Mean Change in Reading Speed
Description	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).
Time Frame	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

Outcome Measure Data

Analysis Population Description

MITT LOCF; 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.

Arm/Group Title	Early AMD	Established AMD
Arm/Group Description	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).	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).
Measure Participants	107	178
Baseline through Week 54 (n=92, n=151)	-9.15 (28.78)	-10.98 (22.31)
Baseline through Week 102 (n=94, n=152)	-17.81 (28.48)	-12.23 (32.08)
Week 54 through Week 102 (n=93, n=152)	-8.43 (18.06)	-1.15 (23.77)

5. Secondary Outcome

Title	Mean Change From Baseline in Contrast Sensitivity
Description	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.
Time Frame	Baseline through Week 54, Baseline through Week 102

Outcome Measure Data

Analysis Population Description

MITT LOCF; 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.

Arm/Group Title	Early AMD	Established AMD
Arm/Group Description	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).	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).
Measure Participants	107	178
Baseline through Week 54 (n=93, n=152)	-0.06 (0.26)	-0.03 (0.33)
Baseline through Week 102 (n=94, n=152)	-0.16 (0.37)	-0.09 (0.39)

6. Secondary Outcome

Title	Mean Change in National Eye Institute - Visual Functioning Questionnaire (NEI-VFQ-25) Composite Score
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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Early AMD	Established AMD
Arm/Group Description	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).	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).
Measure Participants	107	178
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)

7. Secondary Outcome

Title	Mean Change in Euro QoL Questionnaire (EQ-5D) Score
Description	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.
Time Frame	Baseline through Week 54, Baseline through Week 102, and Week 54 through Week 102

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Early AMD	Established AMD
Arm/Group Description	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).	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).
Measure Participants	107	178
Baseline through Week 54 (n=90, n=146)	-0.00 (0.260)	-0.01 (0.227)
Baseline through Week 102 (n=67, n=111)	-0.04 (0.267)	-0.04 (0.207)
Week 54 through Week 102 (n=64, n=115)	-0.01 (0.271)	-0.03 (0.213)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Early AMD		Established AMD
Arm/Group Description	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).		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).
All Cause Mortality
	Early AMD		Established AMD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Early AMD		Established AMD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/107 (21.5%)		32/179 (17.9%)
Blood and lymphatic system disorders
Hypochromic anaemia	1/107 (0.9%)		0/179 (0%)
Cardiac disorders
Angina pectoris	3/107 (2.8%)		0/179 (0%)
Angina unstable	1/107 (0.9%)		1/179 (0.6%)
Atrial fibrillation	1/107 (0.9%)		2/179 (1.1%)
Bradycardia	1/107 (0.9%)		0/179 (0%)
Myocardial infarction	0/107 (0%)		1/179 (0.6%)
Myocardial ischaemia	0/107 (0%)		1/179 (0.6%)
Palpitations	0/107 (0%)		1/179 (0.6%)
Ear and labyrinth disorders
Vertigo	1/107 (0.9%)		0/179 (0%)
Eye disorders
Cataract	1/107 (0.9%)		1/179 (0.6%)
Eye haemorrhage	0/107 (0%)		2/179 (1.1%)
Iridocyclitis	0/107 (0%)		1/179 (0.6%)
Open angle glaucoma	0/107 (0%)		1/179 (0.6%)
Retinal detachment	0/107 (0%)		1/179 (0.6%)
Uveitis	0/107 (0%)		2/179 (1.1%)
Visual acuity reduced	0/107 (0%)		1/179 (0.6%)
Vitritis	0/107 (0%)		1/179 (0.6%)
Gastrointestinal disorders
Abdominal adhesions	1/107 (0.9%)		0/179 (0%)
Duodenal ulcer haemorrhage	0/107 (0%)		1/179 (0.6%)
Inguinal hernia	1/107 (0.9%)		0/179 (0%)
Intestinal ischaemia	1/107 (0.9%)		0/179 (0%)
General disorders
Injection site injury	0/107 (0%)		1/179 (0.6%)
Oedema peripheral	0/107 (0%)		1/179 (0.6%)
Hepatobiliary disorders
Cholecystitis	0/107 (0%)		1/179 (0.6%)
Cholelithiasis	0/107 (0%)		1/179 (0.6%)
Infections and infestations
Cellulitis	0/107 (0%)		1/179 (0.6%)
Endophthalmitis	2/107 (1.9%)		2/179 (1.1%)
Gastroenteritis	0/107 (0%)		1/179 (0.6%)
Herpes zoster	0/107 (0%)		1/179 (0.6%)
Urinary tract infection	0/107 (0%)		1/179 (0.6%)
Injury, poisoning and procedural complications
Fall	1/107 (0.9%)		0/179 (0%)
Femur fracture	1/107 (0.9%)		0/179 (0%)
Hip fracture	1/107 (0.9%)		0/179 (0%)
Lower limb fracture	1/107 (0.9%)		1/179 (0.6%)
Road traffic accident	1/107 (0.9%)		0/179 (0%)
Musculoskeletal and connective tissue disorders
Back pain	1/107 (0.9%)		0/179 (0%)
Intervertebral disc protrusion	1/107 (0.9%)		0/179 (0%)
Pain in extremity	0/107 (0%)		2/179 (1.1%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer	0/107 (0%)		1/179 (0.6%)
Bladder neoplasm	1/107 (0.9%)		0/179 (0%)
Lymphoma	1/107 (0.9%)		0/179 (0%)
Non-Hodgkin's lymphoma	1/107 (0.9%)		0/179 (0%)
Prostate cancer	2/107 (1.9%)		0/179 (0%)
Skin cancer	0/107 (0%)		1/179 (0.6%)
Nervous system disorders
Cerebrovascular accident	0/107 (0%)		3/179 (1.7%)
Loss of consciousness	0/107 (0%)		1/179 (0.6%)
Neuropathy peripheral	1/107 (0.9%)		0/179 (0%)
Transient ischaemic attack	0/107 (0%)		1/179 (0.6%)
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/107 (0%)		1/179 (0.6%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/107 (0%)		1/179 (0.6%)
Dyspnoea	0/107 (0%)		1/179 (0.6%)
Pulmonary embolism	1/107 (0.9%)		0/179 (0%)
Skin and subcutaneous tissue disorders
Dermatitis	0/107 (0%)		1/179 (0.6%)
Surgical and medical procedures
Eye operation	1/107 (0.9%)		0/179 (0%)
Meniscus operation	0/107 (0%)		1/179 (0.6%)
Vascular disorders
Arterial thrombosis limb	1/107 (0.9%)		0/179 (0%)
Peripheral arterial occlusive disease	1/107 (0.9%)		0/179 (0%)
Peripheral ischaemia	0/107 (0%)		1/179 (0.6%)
Phlebitis	1/107 (0.9%)		0/179 (0%)
Other (Not Including Serious) Adverse Events
	Early AMD		Established AMD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	68/107 (63.6%)		120/179 (67%)
Blood and lymphatic system disorders
Anaemia	0/107 (0%)		4/179 (2.2%)
Splenic lesion	1/107 (0.9%)		0/179 (0%)
Cardiac disorders
Aortic valve incompetence	0/107 (0%)		1/179 (0.6%)
Arrhythmia	1/107 (0.9%)		1/179 (0.6%)
Atrial fibrillation	1/107 (0.9%)		2/179 (1.1%)
Cardiac failure	1/107 (0.9%)		0/179 (0%)
Palpitations	0/107 (0%)		1/179 (0.6%)
Congenital, familial and genetic disorders
Corneal dystrophy	1/107 (0.9%)		0/179 (0%)
Ear and labyrinth disorders
Deafness	0/107 (0%)		2/179 (1.1%)
Vertigo	3/107 (2.8%)		2/179 (1.1%)
Eye disorders
Anterior chamber cell	3/107 (2.8%)		3/179 (1.7%)
Anterior chamber flare	1/107 (0.9%)		0/179 (0%)
Anterior chamber pigmentation	2/107 (1.9%)		0/179 (0%)
Aphakia	1/107 (0.9%)		0/179 (0%)
Blepharitis	2/107 (1.9%)		2/179 (1.1%)
Blepharitis allergic	0/107 (0%)		1/179 (0.6%)
Blindness	2/107 (1.9%)		2/179 (1.1%)
Blindness transient	0/107 (0%)		1/179 (0.6%)
Blindness unilateral	3/107 (2.8%)		0/179 (0%)
Cataract	2/107 (1.9%)		4/179 (2.2%)
Cataract nuclear	1/107 (0.9%)		1/179 (0.6%)
Cataract subcapsular	0/107 (0%)		1/179 (0.6%)
Chalazion	1/107 (0.9%)		2/179 (1.1%)
Choroidal neovascularisation	1/107 (0.9%)		6/179 (3.4%)
Ciliary body haemorrhage	0/107 (0%)		1/179 (0.6%)
Conjunctival haemorrhage	17/107 (15.9%)		16/179 (8.9%)
Conjunctival hyperaemia	7/107 (6.5%)		4/179 (2.2%)
Conjunctival oedema	0/107 (0%)		1/179 (0.6%)
Conjunctivitis	7/107 (6.5%)		8/179 (4.5%)
Corneal deposits	0/107 (0%)		1/179 (0.6%)
Corneal disorder	2/107 (1.9%)		2/179 (1.1%)
Corneal epithelium defect	10/107 (9.3%)		4/179 (2.2%)
Corneal erosion	0/107 (0%)		3/179 (1.7%)
Corneal oedema	5/107 (4.7%)		7/179 (3.9%)
Corneal opacity	0/107 (0%)		2/179 (1.1%)
Detachment of retinal pigment epithelium	1/107 (0.9%)		1/179 (0.6%)
Dry eye	1/107 (0.9%)		3/179 (1.7%)
Episcleritis	1/107 (0.9%)		0/179 (0%)
Erythema of eyelid	1/107 (0.9%)		0/179 (0%)
Eye discharge	1/107 (0.9%)		4/179 (2.2%)
Eye disorder	1/107 (0.9%)		2/179 (1.1%)
Eye haemorrhage	3/107 (2.8%)		2/179 (1.1%)
Eye irritation	1/107 (0.9%)		5/179 (2.8%)
Eye pain	9/107 (8.4%)		9/179 (5%)
Eye pruritus	1/107 (0.9%)		0/179 (0%)
Eyelid oedema	1/107 (0.9%)		1/179 (0.6%)
Foreign body sensation in eyes	4/107 (3.7%)		0/179 (0%)
Glaucoma	1/107 (0.9%)		1/179 (0.6%)
Hyalosis asteroid	0/107 (0%)		1/179 (0.6%)
Hyphaema	0/107 (0%)		1/179 (0.6%)
Iridocyclitis	0/107 (0%)		3/179 (1.7%)
Keratoconjunctivitis sicca	0/107 (0%)		1/179 (0.6%)
Lacrimation increased	6/107 (5.6%)		2/179 (1.1%)
Lens disorder	1/107 (0.9%)		0/179 (0%)
Macular degeneration	2/107 (1.9%)		5/179 (2.8%)
Maculopathy	0/107 (0%)		1/179 (0.6%)
Metamorphopsia	3/107 (2.8%)		1/179 (0.6%)
Myodesopsia	6/107 (5.6%)		4/179 (2.2%)
Ocular hyperaemia	3/107 (2.8%)		3/179 (1.7%)
Ocular hypertension	0/107 (0%)		2/179 (1.1%)
Photophobia	2/107 (1.9%)		1/179 (0.6%)
Photopsia	1/107 (0.9%)		1/179 (0.6%)
Posterior capsule opacification	1/107 (0.9%)		3/179 (1.7%)
Punctate keratitis	0/107 (0%)		2/179 (1.1%)
Retinal artery spasm	0/107 (0%)		1/179 (0.6%)
Retinal exudates	1/107 (0.9%)		1/179 (0.6%)
Retinal haemorrhage	3/107 (2.8%)		9/179 (5%)
Retinal oedema	1/107 (0.9%)		0/179 (0%)
Retinal pigment epithelial tear	1/107 (0.9%)		1/179 (0.6%)
Scleral haemorrhage	0/107 (0%)		1/179 (0.6%)
Vision blurred	3/107 (2.8%)		1/179 (0.6%)
Visual acuity reduced	2/107 (1.9%)		9/179 (5%)
Visual impairment	2/107 (1.9%)		4/179 (2.2%)
Vitreous detachment	3/107 (2.8%)		1/179 (0.6%)
Vitreous disorder	7/107 (6.5%)		6/179 (3.4%)
Vitreous haemorrhage	2/107 (1.9%)		3/179 (1.7%)
Vitreous opacities	1/107 (0.9%)		1/179 (0.6%)
Vitritis	0/107 (0%)		1/179 (0.6%)
Dental plaque	1/107 (0.9%)		0/179 (0%)
Gastrointestinal disorders
Abdominal pain	0/107 (0%)		1/179 (0.6%)
Abdominal pain lower	0/107 (0%)		1/179 (0.6%)
Abdominal pain upper	1/107 (0.9%)		1/179 (0.6%)
Colitis	1/107 (0.9%)		1/179 (0.6%)
Constipation	0/107 (0%)		4/179 (2.2%)
Dental caries	1/107 (0.9%)		1/179 (0.6%)
Diarrhoea	3/107 (2.8%)		2/179 (1.1%)
Duodenogastric reflux	1/107 (0.9%)		0/179 (0%)
Dyspepsia	0/107 (0%)		1/179 (0.6%)
Food poisoning	0/107 (0%)		1/179 (0.6%)
Gastritis	0/107 (0%)		2/179 (1.1%)
Gastritis erosive	0/107 (0%)		1/179 (0.6%)
Gingivitis	1/107 (0.9%)		0/179 (0%)
Hiatus hernia	0/107 (0%)		1/179 (0.6%)
Irritable bowel syndrome	0/107 (0%)		1/179 (0.6%)
Mouth ulceration	0/107 (0%)		1/179 (0.6%)
Nausea	1/107 (0.9%)		1/179 (0.6%)
Pancreatitis chronic	0/107 (0%)		1/179 (0.6%)
Rectal prolapse	0/107 (0%)		1/179 (0.6%)
Salivary hypersecretion	1/107 (0.9%)		0/179 (0%)
Toothache	0/107 (0%)		1/179 (0.6%)
General disorders
Asthenia	0/107 (0%)		1/179 (0.6%)
Chest pain	0/107 (0%)		2/179 (1.1%)
Fatigue	0/107 (0%)		1/179 (0.6%)
Influenza like illness	1/107 (0.9%)		0/179 (0%)
Injection site haemorrhage	1/107 (0.9%)		4/179 (2.2%)
Injection site irritation	0/107 (0%)		2/179 (1.1%)
Injection site pain	1/107 (0.9%)		4/179 (2.2%)
Injection site reaction	2/107 (1.9%)		0/179 (0%)
Pain	2/107 (1.9%)		0/179 (0%)
Polyp	0/107 (0%)		1/179 (0.6%)
Pyrexia	2/107 (1.9%)		0/179 (0%)
Therapeutic response unexpected	0/107 (0%)		1/179 (0.6%)
Hepatobiliary disorders
Hepatic cyst	1/107 (0.9%)		1/179 (0.6%)
Hepatic steatosis	0/107 (0%)		1/179 (0.6%)
Hyperbilirubinaemia	0/107 (0%)		1/179 (0.6%)
Liver disorder	1/107 (0.9%)		0/179 (0%)
Immune system disorders
Drug hypersensitivity	1/107 (0.9%)		2/179 (1.1%)
Hypersensitivity	0/107 (0%)		1/179 (0.6%)
Infections and infestations
Abscess	0/107 (0%)		1/179 (0.6%)
Bronchitis	2/107 (1.9%)		8/179 (4.5%)
Candidiasis	0/107 (0%)		1/179 (0.6%)
Conjunctivitis bacterial	1/107 (0.9%)		0/179 (0%)
Cystitis	1/107 (0.9%)		2/179 (1.1%)
Dacryocystitis	1/107 (0.9%)		0/179 (0%)
Erysipelas	1/107 (0.9%)		0/179 (0%)
Eye infection	1/107 (0.9%)		0/179 (0%)
Fungal skin infection	0/107 (0%)		1/179 (0.6%)
Gastroenteritis	1/107 (0.9%)		2/179 (1.1%)
Gastrointestinal fungal infection	1/107 (0.9%)		0/179 (0%)
Gingival infection	0/107 (0%)		1/179 (0.6%)
Herpes virus infection	0/107 (0%)		1/179 (0.6%)
Herpes zoster	1/107 (0.9%)		1/179 (0.6%)
Hordeolum	0/107 (0%)		2/179 (1.1%)
Incision site infection	0/107 (0%)		1/179 (0.6%)
Infective exacerbation of chronic obstructive airways disease	0/107 (0%)		1/179 (0.6%)
Influenza	2/107 (1.9%)		5/179 (2.8%)
Keratitis herpetic	0/107 (0%)		1/179 (0.6%)
Laryngitis	0/107 (0%)		2/179 (1.1%)
Lower respiratory tract infection	1/107 (0.9%)		4/179 (2.2%)
Nasopharyngitis	9/107 (8.4%)		10/179 (5.6%)
Otitis media	0/107 (0%)		2/179 (1.1%)
Pharyngitis	0/107 (0%)		1/179 (0.6%)
Pneumonia	1/107 (0.9%)		1/179 (0.6%)
Pulpitis dental	0/107 (0%)		1/179 (0.6%)
Respiratory tract infection	1/107 (0.9%)		0/179 (0%)
Rhinitis	0/107 (0%)		1/179 (0.6%)
Sinusitis	0/107 (0%)		3/179 (1.7%)
Tooth abscess	1/107 (0.9%)		1/179 (0.6%)
Tooth infection	0/107 (0%)		3/179 (1.7%)
Upper respiratory tract infection	3/107 (2.8%)		5/179 (2.8%)
Urethritis	1/107 (0.9%)		0/179 (0%)
Urinary tract infection	3/107 (2.8%)		1/179 (0.6%)
Viral infection	1/107 (0.9%)		0/179 (0%)
Injury, poisoning and procedural complications
Accidental exposure	1/107 (0.9%)		0/179 (0%)
Cataract operation complication	0/107 (0%)		1/179 (0.6%)
Contusion	1/107 (0.9%)		2/179 (1.1%)
Corneal abrasion	0/107 (0%)		1/179 (0.6%)
Fall	2/107 (1.9%)		3/179 (1.7%)
Head injury	1/107 (0.9%)		0/179 (0%)
Hip fracture	1/107 (0.9%)		0/179 (0%)
Joint dislocation	1/107 (0.9%)		2/179 (1.1%)
Joint sprain	0/107 (0%)		1/179 (0.6%)
Ligament injury	1/107 (0.9%)		0/179 (0%)
Muscle strain	1/107 (0.9%)		0/179 (0%)
Periorbital haematoma	0/107 (0%)		1/179 (0.6%)
Post procedural discomfort	0/107 (0%)		1/179 (0.6%)
Procedural pain	0/107 (0%)		2/179 (1.1%)
Skeletal injury	1/107 (0.9%)		0/179 (0%)
Upper limb fracture	0/107 (0%)		1/179 (0.6%)
Investigations
Blood glucose increased	1/107 (0.9%)		0/179 (0%)
Blood pressure abnormal	0/107 (0%)		1/179 (0.6%)
Blood pressure increased	0/107 (0%)		3/179 (1.7%)
Blood uric acid increased	0/107 (0%)		1/179 (0.6%)
Gamma-glutamyltransferase increased	1/107 (0.9%)		0/179 (0%)
Haemoglobin decreased	0/107 (0%)		1/179 (0.6%)
Intraocular pressure decreased	1/107 (0.9%)		0/179 (0%)
Intraocular pressure increased	8/107 (7.5%)		15/179 (8.4%)
Ultrasound Doppler normal	1/107 (0.9%)		0/179 (0%)
Metabolism and nutrition disorders
Anorexia	0/107 (0%)		1/179 (0.6%)
Dyslipidaemia	0/107 (0%)		1/179 (0.6%)
Hypercholesterolaemia	0/107 (0%)		3/179 (1.7%)
Hyperglycaemia	1/107 (0.9%)		0/179 (0%)
Hyperhomocysteinaemia	1/107 (0.9%)		0/179 (0%)
Hyperuricaemia	0/107 (0%)		1/179 (0.6%)
Hypoglycaemia	0/107 (0%)		1/179 (0.6%)
Type 2 diabetes mellitus	1/107 (0.9%)		0/179 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/107 (1.9%)		2/179 (1.1%)
Arthritis	2/107 (1.9%)		3/179 (1.7%)
Back pain	3/107 (2.8%)		2/179 (1.1%)
Bone pain	0/107 (0%)		1/179 (0.6%)
Exostosis	1/107 (0.9%)		0/179 (0%)
Jaw cyst	0/107 (0%)		1/179 (0.6%)
Musculoskeletal chest pain	1/107 (0.9%)		0/179 (0%)
Musculoskeletal pain	0/107 (0%)		2/179 (1.1%)
Neck pain	0/107 (0%)		2/179 (1.1%)
Osteoarthritis	1/107 (0.9%)		4/179 (2.2%)
Osteochondrosis	1/107 (0.9%)		0/179 (0%)
Pain in extremity	0/107 (0%)		4/179 (2.2%)
Tendonitis	1/107 (0.9%)		0/179 (0%)
Torticollis	1/107 (0.9%)		0/179 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma	1/107 (0.9%)		0/179 (0%)
Basal cell carcinoma	1/107 (0.9%)		0/179 (0%)
Gastrointestinal tract adenoma	0/107 (0%)		1/179 (0.6%)
Neoplasm skin	0/107 (0%)		1/179 (0.6%)
Non-small cell lung cancer	0/107 (0%)		1/179 (0.6%)
Pancreatic carcinoma	0/107 (0%)		1/179 (0.6%)
Nervous system disorders
Aphasia	1/107 (0.9%)		0/179 (0%)
Balance disorder	1/107 (0.9%)		0/179 (0%)
Carpal tunnel syndrome	1/107 (0.9%)		1/179 (0.6%)
Dizziness	0/107 (0%)		1/179 (0.6%)
Headache	4/107 (3.7%)		7/179 (3.9%)
Hemicephalalgia	0/107 (0%)		1/179 (0.6%)
Hyperaesthesia	2/107 (1.9%)		0/179 (0%)
Hypertonia	1/107 (0.9%)		0/179 (0%)
Hypoaesthesia	1/107 (0.9%)		0/179 (0%)
Hyposmia	1/107 (0.9%)		0/179 (0%)
Neuralgia	1/107 (0.9%)		0/179 (0%)
Neuropathy peripheral	1/107 (0.9%)		0/179 (0%)
Post herpetic neuralgia	0/107 (0%)		1/179 (0.6%)
Presyncope	1/107 (0.9%)		0/179 (0%)	0
Sciatica	1/107 (0.9%)		1/179 (0.6%)
Transient ischaemic attack	0/107 (0%)		1/179 (0.6%)
Trigeminal neuralgia	0/107 (0%)		1/179 (0.6%)
Visual field defect	1/107 (0.9%)		1/179 (0.6%)
Psychiatric disorders
Anxiety	1/107 (0.9%)		2/179 (1.1%)
Confusional state	1/107 (0.9%)		0/179 (0%)
Depressed mood	1/107 (0.9%)		0/179 (0%)
Depression	2/107 (1.9%)		0/179 (0%)
Insomnia	0/107 (0%)		2/179 (1.1%)
Nervousness	0/107 (0%)		1/179 (0.6%)
Reading disorder	1/107 (0.9%)		0/179 (0%)
Sleep disorder	1/107 (0.9%)		0/179 (0%)
Renal and urinary disorders
Micturition urgency	0/107 (0%)		1/179 (0.6%)
Nephrolithiasis	1/107 (0.9%)		0/179 (0%)
Renal cyst	0/107 (0%)		1/179 (0.6%)
Reproductive system and breast disorders
Breast cyst	1/107 (0.9%)		0/179 (0%)
Cystocele	0/107 (0%)		1/179 (0.6%)
Metrorrhagia	0/107 (0%)		1/179 (0.6%)
Prostatitis	1/107 (0.9%)		1/179 (0.6%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/107 (0%)		1/179 (0.6%)
Chronic obstructive pulmonary disease	2/107 (1.9%)		0/179 (0%)
Cough	1/107 (0.9%)		4/179 (2.2%)
Dyspnoea	1/107 (0.9%)		0/179 (0%)
Emphysema	1/107 (0.9%)		1/179 (0.6%)
Epistaxis	2/107 (1.9%)		0/179 (0%)
Oropharyngeal pain	2/107 (1.9%)		0/179 (0%)
Pleural effusion	0/107 (0%)		1/179 (0.6%)
Skin and subcutaneous tissue disorders
Acne	0/107 (0%)		1/179 (0.6%)
Dermal cyst	0/107 (0%)		1/179 (0.6%)
Dermatitis	1/107 (0.9%)		1/179 (0.6%)
Erythema	1/107 (0.9%)		0/179 (0%)
Pruritus	1/107 (0.9%)		0/179 (0%)
Rash	2/107 (1.9%)		0/179 (0%)
Surgical and medical procedures
Abscess drainage	0/107 (0%)		1/179 (0.6%)
Bladder neoplasm surgery	1/107 (0.9%)		0/179 (0%)
Carpal tunnel decompression	0/107 (0%)		1/179 (0.6%)
Curetting of chalazion	0/107 (0%)		1/179 (0.6%)
Gingival operation	1/107 (0.9%)		0/179 (0%)
Malignant tumour excision	1/107 (0.9%)		0/179 (0%)
Tooth extraction	1/107 (0.9%)		0/179 (0%)
Vascular disorders
Deep vein thrombosis	1/107 (0.9%)		0/179 (0%)
Haematoma	0/107 (0%)		3/179 (1.7%)
Hypertension	5/107 (4.7%)		10/179 (5.6%)
Orthostatic hypotension	1/107 (0.9%)		0/179 (0%)
Phlebitis	1/107 (0.9%)		0/179 (0%)
Varicose vein	0/107 (0%)		1/179 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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.