MACULA: Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00858208
• Collaborator: (none)
• Enrollment: 86
• Locations: 8
• Duration (Months): 37
• Patients Per Site: 10.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-related Macular Degeneration	Drug: pegaptanib sodium

Detailed Description

Eligible patients in routine clinical practice

Study Design

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Long-Term Non-Interventional Study To Investigate The Efficacy And Safety Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice.
• Study Start Date: Mar 1, 2008
• Actual Primary Completion Date: Apr 1, 2011
• Actual Study Completion Date: Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Patients with neovascular Age-Related Macula Degeneration	Drug: pegaptanib sodium; pegaptanib sodium intravitreal injection every 6 weeks for 2 years

Outcome Measures

Primary Outcome Measures

1. Change From Baseline Visual Acuity (VA) at the Final Visit [Baseline, Week 102 or Early Termination (ET)]

   VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.

Secondary Outcome Measures

1. Change From Baseline VA at Each Visit [Baseline, every 6 weeks up to Week 102]

   VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.

2. Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED) [Baseline, Week 102 or ET]

   VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the "Pigment Epithelial Detachment (PED) present" box ticked at Baseline Visit.

3. Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit [Baseline, Month 6, 12, 18, and 24]

   Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.

4. Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit [Baseline, Week 102 or ET]

   Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.

5. Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit [Baseline, Week 102 or ET]

   Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.

Other Outcome Measures

1. Change From Baseline VA at Final Visit by Age Group [Baseline, Week 102 or ET]

   Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to [>=] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.

2. Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage [Baseline, Week 102 or ET]

   Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.

3. Change From Baseline VA at the Final Visit by Previous Treatment of AMD [Baseline, Week 102 or ET]

   Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.

4. Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment [Every 6 weeks up to Week 102]

   Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.

5. Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment [Every 6 weeks up to Week 102]

   Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.

6. Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment [Every 6 weeks up to Week 102]

   Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.

7. Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study [Baseline through Week 102]

   Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).

8. Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection) [Baseline and Week 102 or ET]

   IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

adults with neovascular age-related macula degeneration

Exclusion Criteria:

according to SmPC

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Patras	Pellopoese	Greece
2	Pfizer Investigational Site	Alexandroupoli		Greece
3	Pfizer Investigational Site	Athens		Greece	12462
4	Pfizer Investigational Site	Athens		Greece
5	Pfizer Investigational Site	Larisa		Greece
6	Pfizer Investigational Site	Patra		Greece
7	Pfizer Investigational Site	Thessaloniki		Greece
8	Pfizer Investigational Site	Xanthi		Greece

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: NCT00858208
• Other Study ID Numbers: A5751028
• First Posted: Mar 9, 2009
• Last Update Posted: Apr 11, 2012
• Last Verified: Sep 1, 2011

• Keywords provided by Pfizer: efficacy and safety of Macugen in routine clinical practice
• Additional relevant MeSH terms: Macular Degeneration; Wet Macular Degeneration

Study Results

Participant Flow

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Period Title: Overall Study
STARTED	85
COMPLETED	6
NOT COMPLETED	79

Baseline Characteristics

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Overall Participants	85
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	74.0 (6.8)
Sex: Female, Male (Count of Participants)
Female	44 51.8%
Male	41 48.2%
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline (scores on a scale) [Mean (Standard Deviation) ]
General Health (n=85)	45.00 (23.081)
General Vision (n=85)	55.53 (16.439)
Ocular Pain (n=85)	80.74 (20.912)
Near Activities (n=85)	53.09 (28.976)
Distance Activities (n=85)	58.73 (28.264)
Social Functioning (n=85)	72.35 (28.809)
Mental Health (n=85)	50.51 (24.056)
Role Difficulties (n=85)	57.06 (31.425)
Dependency (n=85)	61.27 (28.542)
Driving (n=30)	49.72 (35.523)
Color Vision (n=83)	79.82 (23.896)
Peripheral Vision (n=85)	67.65 (29.586)
Procedures used for age-related macular degeneration (AMD) diagnosis (participants) [Number]
fluorescein angiography	66 77.6%
indocyanine green angiography	0 0%
optical coherence tomography	18 21.2%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline Visual Acuity (VA) at the Final Visit
Description	VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Time Frame	Baseline, Week 102 or Early Termination (ET)

Outcome Measure Data

Analysis Population Description

Safety Analysis Set (SAS) = Full Analysis Set (FAS): Enrolled participants who received at least 1 dose of Pegaptanib; Number of participants analyzed (N)=participants with evaluable data

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	67
Measure eyes	67
Baseline	0.829 (0.367)
Change at Week 102/ET	-0.126 (0.371)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0072
	Comments
	Method	paired t-test
	Comments

2. Secondary Outcome

Title	Change From Baseline VA at Each Visit
Description	VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Time Frame	Baseline, every 6 weeks up to Week 102

Outcome Measure Data

Analysis Population Description

SAS; Number of participants analyzed (N)=participants with evaluable data; n=participants with evaluable data at specified time point

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	67
Measure eyes	67
Change at Week 6 (n=59)	-0.07 (0.249)
Change at Week 12 (n=56)	-0.10 (0.297)
Change at Week 18 (n=48)	-0.12 (0.374)
Change at Week 24 (n=43)	-0.16 (0.406)
Change at Week 30 (n=37)	-0.16 (0.415)
Change at Week 36 (n=31)	-0.17 (0.416)
Change at Week 42 (n=28)	-0.12 (0.455)
Change at Week 48 (n=25)	-0.13 (0.472)
Change at Week 54 (n=23)	-0.07 (0.461)
Change at Week 60 (n=19)	-0.09 (0.500)
Change at Week 66 (n=13)	0.04 (0.558)
Change at Week 72 (n=10)	0.05 (0.495)
Change at Week 84 (n=8)	-0.04 (0.302)
Change at Week 90 (n=4)	-0.11 (0.334)
Change at Week 96 (n=2)	0.33 (0.213)
Change at Week 102 (n=2)	0.33 (0.213)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0433
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0133
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 18
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0278
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0160
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 30
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0264
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 36
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0278
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 42
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1854
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 48
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1684
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 54
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4718
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 60
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.4340
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 66
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7765
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 72
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7544
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 84
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7201
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 90
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5692
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 96
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2749
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change from baseline at Week 102
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2749
	Comments
	Method	paired t-test
	Comments

3. Secondary Outcome

Title	Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
Description	VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the "Pigment Epithelial Detachment (PED) present" box ticked at Baseline Visit.
Time Frame	Baseline, Week 102 or ET

Outcome Measure Data

Analysis Population Description

SAS subset of participants with RPED at baseline

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	28
Measure eyes	28
Baseline	0.804 (0.386)
Change at Week 102/ET	-0.105 (0.443)

4. Secondary Outcome

Title	Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Description	Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Time Frame	Baseline, Month 6, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	30
Baseline (n=30)	67.73 (21.126)
Change at Month 6 (n=19)	2.62 (10.647)
Change at Month 12 (n=13)	4.22 (9.596)
Change at Month 18 (n=4)	-2.33 (1.549)
Change at Month 24 (n=2)	-2.56 (9.241)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change at Month 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2970
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change at Month 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1392
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change at Month 18
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0573
	Comments
	Method	paired t-test
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments	Change at Month 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7625
	Comments
	Method	paired t-test
	Comments

5. Secondary Outcome

Title	Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Description	Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Time Frame	Baseline, Week 102 or ET

Outcome Measure Data

Analysis Population Description

SAS; N=participants with evaluable data

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	20
Baseline	69.47 (21.62)
Change at Week 102/ET	3.21 (12.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pegaptanib
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.2759
	Comments
	Method	paired t-test
	Comments

6. Secondary Outcome

Title	Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Description	Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.
Time Frame	Baseline, Week 102 or ET

Outcome Measure Data

Analysis Population Description

SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point and item in questionnaire

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	85
General Health, Change at Week 102/ET (n=59)	-1.69 (22.198)
General Vision, Change at Week 102/ET (n=59)	5.08 (16.014)
Ocular Pain, Change at Week 102/ET (n=59)	-4.87 (15.746)
Near Activities, Change at Week 102/ET (n=59)	5.93 (21.709)
Distance Activities, Change at Week 102/ET (n=59)	0.71 (20.532)
Social Functioning, Change at Week 102/ET (n=59)	1.91 (22.602)
Mental Health, Change at Week 102/ET (n=59)	3.81 (18.461)
Role Difficulties, Change at Week 102/ET (n=59)	4.45 (17.794)
Dependency, Change at Week 102/ET (n=59)	6.07 (18.751)
Driving, Change at Week 102/ET (n=20)	-2.50 (14.075)
Color Vision, Change at Week 102/ET (n=57)	3.07 (20.084)
Peripheral Vision, Change at Week 102/ET (n=59)	5.08 (19.575)

7. Other Pre-specified Outcome

Title	Change From Baseline VA at Final Visit by Age Group
Description	Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to [>=] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
Time Frame	Baseline, Week 102 or ET

Outcome Measure Data

Analysis Population Description

SAS;N=participants with evaluable data; n=participants with evaluable data at specified time point and age group

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	67
Measure eyes	67
51-64 years, Baseline (n=10)	0.797 (0.361)
51-64 years, Change at Week 102/ET (n=10)	-0.156 (0.253)
≥ 65 years, Baseline (n=57)	0.835 (0.371)
≥ 65 years, Change at Week 102/ET (n=57)	-0.121 (0.390)

8. Other Pre-specified Outcome

Title	Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Description	Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
Time Frame	Baseline, Week 102 or ET

Outcome Measure Data

Analysis Population Description

SAS subset of participants with AMD; n=participants with evaluable data at specified time point and stage of AMD

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	66
Measure eyes	66
Early Lesion, Baseline (n=34)	0.704 (0.332)
Early Lesion, Change at Week 102/ET (n=34)	-0.066 (0.395)
Late Stage Lesion, Baseline (n=31)	0.961 (0.358)
Late Stage Lesion, Change at Week 102/ET (n=31)	-0.190 (0.348)
Other AMD Stage, Baseline (n=1)	1.301 (NA)
Other AMD Stage, Change at Week 102/ET (n=1)	-0.301 (NA)

9. Other Pre-specified Outcome

Title	Change From Baseline VA at the Final Visit by Previous Treatment of AMD
Description	Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
Time Frame	Baseline, Week 102 or ET

Outcome Measure Data

Analysis Population Description

SAS subset of participants for who data was collected about previous AMD treatment (yes/no); n=number of participants with evaluable data at specified time point

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	67
Measure eyes	67
No Previous AMD Treatment, Baseline (n=62)	0.838 (0.363)
No Previous Treatment, Change at Week 102/ET(n=62)	-0.126 (0.367)
Previous AMD Treatment, Baseline (n=5)	0.724 (0.438)
Previous Treatment, Change at Week 102/ET (n=5)	-0.120 (0.461)

10. Other Pre-specified Outcome

Title	Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Description	Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.
Time Frame	Every 6 weeks up to Week 102

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	85
Week 6	8 9.4%
Week 12	7 8.2%
Week 18	6 7.1%
Week 24	7 8.2%
Week 30	11 12.9%
Week 36	4 4.7%
Week 42	3 3.5%
Week 48	4 4.7%
Week 54	2 2.4%
Week 60	4 4.7%
Week 66	2 2.4%
Week 72	0 0%
Week 78	0 0%
Week 84	1 1.2%
Week 90	1 1.2%
Week 96	0 0%
Week 102	1 1.2%

11. Other Pre-specified Outcome

Title	Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Description	Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.
Time Frame	Every 6 weeks up to Week 102

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	85
Week 6	32 37.6%
Week 12	35 41.2%
Week 18	34 40%
Week 24	31 36.5%
Week 30	24 28.2%
Week 36	26 30.6%
Week 42	21 24.7%
Week 48	17 20%
Week 54	16 18.8%
Week 60	16 18.8%
Week 66	10 11.8%
Week 72	6 7.1%
Week 78	0 0%
Week 84	7 8.2%
Week 90	5 5.9%
Week 96	1 1.2%
Week 102	1 1.2%

12. Other Pre-specified Outcome

Title	Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Description	Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.
Time Frame	Every 6 weeks up to Week 102

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	85
Week 6	0 0%
Week 12	0 0%
Week 18	0 0%
Week 24	0 0%
Week 30	0 0%
Week 36	1 1.2%
Week 42	0 0%
Week 48	0 0%
Week 54	0 0%
Week 60	0 0%
Week 66	0 0%
Week 72	0 0%
Week 78	0 0%
Week 84	0 0%
Week 90	0 0%
Week 96	0 0%
Week 102	0 0%

13. Other Pre-specified Outcome

Title	Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study
Description	Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).
Time Frame	Baseline through Week 102

Outcome Measure Data

Analysis Population Description

SAS

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	85
Number [participants]	3 3.5%

14. Other Pre-specified Outcome

Title	Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)
Description	IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.
Time Frame	Baseline and Week 102 or ET

Outcome Measure Data

Analysis Population Description

SAS; N=participants with evaluable data at baseline; n=participants with evaluable data at specified time point

Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
Measure Participants	78
Measure eyes	78
Baseline (n=78)	15.0 (3.2)
Pre-dose, Change at Week 102/ET (n=74)	0.3 (2.7)
Post-dose, Change at Week 102/ET (n=75)	0.8 (3.1)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Pegaptanib
Arm/Group Description	The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
All Cause Mortality
	Pegaptanib
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Pegaptanib
	Affected / at Risk (%)	# Events
Total	1/85 (1.2%)
Gastrointestinal disorders
Intestinal polyp	1/85 (1.2%)
Other (Not Including Serious) Adverse Events
	Pegaptanib
	Affected / at Risk (%)	# Events
Total	5/85 (5.9%)
Eye disorders
Retinal tear	1/85 (1.2%)
Uveitis	1/85 (1.2%)
General disorders
Asthenia	1/85 (1.2%)
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus	1/85 (1.2%)
Nervous system disorders
Dizziness	1/85 (1.2%)
Skin and subcutaneous tissue disorders
Rash	1/85 (1.2%)

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.