Trial Outcomes & Findings for Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice. (NCT NCT00858208)
NCT ID: NCT00858208
Last Updated: 2012-04-11
Results Overview
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.
COMPLETED
86 participants
Baseline, Week 102 or Early Termination (ET)
2012-04-11
Participant Flow
Participant milestones
| Measure |
Pegaptanib
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.
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|---|---|
|
Overall Study
STARTED
|
85
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
79
|
Reasons for withdrawal
| Measure |
Pegaptanib
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.
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|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Lost to Follow-up
|
26
|
|
Overall Study
Participant refused
|
40
|
|
Overall Study
Other
|
10
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Baseline Characteristics
Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
Baseline characteristics by cohort
| Measure |
Pegaptanib
n=85 Participants
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.
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|---|---|
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Age Continuous
|
74.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
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Sex: Female, Male
Female
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44 Participants
n=5 Participants
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Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
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National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
General Health (n=85)
|
45.00 scores on a scale
STANDARD_DEVIATION 23.081 • n=5 Participants
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|
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
General Vision (n=85)
|
55.53 scores on a scale
STANDARD_DEVIATION 16.439 • n=5 Participants
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|
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Ocular Pain (n=85)
|
80.74 scores on a scale
STANDARD_DEVIATION 20.912 • n=5 Participants
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|
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Near Activities (n=85)
|
53.09 scores on a scale
STANDARD_DEVIATION 28.976 • n=5 Participants
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|
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Distance Activities (n=85)
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58.73 scores on a scale
STANDARD_DEVIATION 28.264 • n=5 Participants
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National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Social Functioning (n=85)
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72.35 scores on a scale
STANDARD_DEVIATION 28.809 • n=5 Participants
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|
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Mental Health (n=85)
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50.51 scores on a scale
STANDARD_DEVIATION 24.056 • n=5 Participants
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National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Role Difficulties (n=85)
|
57.06 scores on a scale
STANDARD_DEVIATION 31.425 • n=5 Participants
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National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Dependency (n=85)
|
61.27 scores on a scale
STANDARD_DEVIATION 28.542 • n=5 Participants
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|
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Driving (n=30)
|
49.72 scores on a scale
STANDARD_DEVIATION 35.523 • n=5 Participants
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|
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Color Vision (n=83)
|
79.82 scores on a scale
STANDARD_DEVIATION 23.896 • n=5 Participants
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|
National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline
Peripheral Vision (n=85)
|
67.65 scores on a scale
STANDARD_DEVIATION 29.586 • n=5 Participants
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Procedures used for age-related macular degeneration (AMD) diagnosis
fluorescein angiography
|
66 participants
n=5 Participants
|
|
Procedures used for age-related macular degeneration (AMD) diagnosis
indocyanine green angiography
|
0 participants
n=5 Participants
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|
Procedures used for age-related macular degeneration (AMD) diagnosis
optical coherence tomography
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 102 or Early Termination (ET)Population: 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
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.
Outcome measures
| Measure |
Pegaptanib
n=67 Participants
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.
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|---|---|
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Change From Baseline Visual Acuity (VA) at the Final Visit
Baseline
|
0.829 logMAR
Standard Deviation 0.367
|
|
Change From Baseline Visual Acuity (VA) at the Final Visit
Change at Week 102/ET
|
-0.126 logMAR
Standard Deviation 0.371
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SECONDARY outcome
Timeframe: Baseline, every 6 weeks up to Week 102Population: SAS; Number of participants analyzed (N)=participants with evaluable data; n=participants with evaluable data at specified time point
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.
Outcome measures
| Measure |
Pegaptanib
n=67 eyes
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.
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|---|---|
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Change From Baseline VA at Each Visit
Change at Week 6 (n=59)
|
-0.07 logMAR
Standard Deviation 0.249
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|
Change From Baseline VA at Each Visit
Change at Week 12 (n=56)
|
-0.10 logMAR
Standard Deviation 0.297
|
|
Change From Baseline VA at Each Visit
Change at Week 18 (n=48)
|
-0.12 logMAR
Standard Deviation 0.374
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Change From Baseline VA at Each Visit
Change at Week 24 (n=43)
|
-0.16 logMAR
Standard Deviation 0.406
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Change From Baseline VA at Each Visit
Change at Week 30 (n=37)
|
-0.16 logMAR
Standard Deviation 0.415
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|
Change From Baseline VA at Each Visit
Change at Week 36 (n=31)
|
-0.17 logMAR
Standard Deviation 0.416
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|
Change From Baseline VA at Each Visit
Change at Week 42 (n=28)
|
-0.12 logMAR
Standard Deviation 0.455
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Change From Baseline VA at Each Visit
Change at Week 48 (n=25)
|
-0.13 logMAR
Standard Deviation 0.472
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|
Change From Baseline VA at Each Visit
Change at Week 54 (n=23)
|
-0.07 logMAR
Standard Deviation 0.461
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Change From Baseline VA at Each Visit
Change at Week 60 (n=19)
|
-0.09 logMAR
Standard Deviation 0.500
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Change From Baseline VA at Each Visit
Change at Week 66 (n=13)
|
0.04 logMAR
Standard Deviation 0.558
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Change From Baseline VA at Each Visit
Change at Week 72 (n=10)
|
0.05 logMAR
Standard Deviation 0.495
|
|
Change From Baseline VA at Each Visit
Change at Week 84 (n=8)
|
-0.04 logMAR
Standard Deviation 0.302
|
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Change From Baseline VA at Each Visit
Change at Week 90 (n=4)
|
-0.11 logMAR
Standard Deviation 0.334
|
|
Change From Baseline VA at Each Visit
Change at Week 96 (n=2)
|
0.33 logMAR
Standard Deviation 0.213
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|
Change From Baseline VA at Each Visit
Change at Week 102 (n=2)
|
0.33 logMAR
Standard Deviation 0.213
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SECONDARY outcome
Timeframe: Baseline, Week 102 or ETPopulation: SAS subset of participants with RPED at baseline
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.
Outcome measures
| Measure |
Pegaptanib
n=28 eyes
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.
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|---|---|
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Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
Baseline
|
0.804 logMAR
Standard Deviation 0.386
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Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
Change at Week 102/ET
|
-0.105 logMAR
Standard Deviation 0.443
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SECONDARY outcome
Timeframe: Baseline, Month 6, 12, 18, and 24Population: SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point
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.
Outcome measures
| Measure |
Pegaptanib
n=30 Participants
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.
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|---|---|
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Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Baseline (n=30)
|
67.73 scores on a scale
Standard Deviation 21.126
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Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Change at Month 6 (n=19)
|
2.62 scores on a scale
Standard Deviation 10.647
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Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Change at Month 12 (n=13)
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4.22 scores on a scale
Standard Deviation 9.596
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Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Change at Month 18 (n=4)
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-2.33 scores on a scale
Standard Deviation 1.549
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|
Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Change at Month 24 (n=2)
|
-2.56 scores on a scale
Standard Deviation 9.241
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SECONDARY outcome
Timeframe: Baseline, Week 102 or ETPopulation: SAS; N=participants with evaluable data
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.
Outcome measures
| Measure |
Pegaptanib
n=20 Participants
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.
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|---|---|
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Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Baseline
|
69.47 scores on a scale
Standard Deviation 21.62
|
|
Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Change at Week 102/ET
|
3.21 scores on a scale
Standard Deviation 12.78
|
SECONDARY outcome
Timeframe: Baseline, Week 102 or ETPopulation: SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point and item in questionnaire
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.
Outcome measures
| Measure |
Pegaptanib
n=85 Participants
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.
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|---|---|
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
General Health, Change at Week 102/ET (n=59)
|
-1.69 scores on a scale
Standard Deviation 22.198
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
General Vision, Change at Week 102/ET (n=59)
|
5.08 scores on a scale
Standard Deviation 16.014
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Ocular Pain, Change at Week 102/ET (n=59)
|
-4.87 scores on a scale
Standard Deviation 15.746
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Near Activities, Change at Week 102/ET (n=59)
|
5.93 scores on a scale
Standard Deviation 21.709
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|
Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Distance Activities, Change at Week 102/ET (n=59)
|
0.71 scores on a scale
Standard Deviation 20.532
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Social Functioning, Change at Week 102/ET (n=59)
|
1.91 scores on a scale
Standard Deviation 22.602
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Mental Health, Change at Week 102/ET (n=59)
|
3.81 scores on a scale
Standard Deviation 18.461
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Role Difficulties, Change at Week 102/ET (n=59)
|
4.45 scores on a scale
Standard Deviation 17.794
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Dependency, Change at Week 102/ET (n=59)
|
6.07 scores on a scale
Standard Deviation 18.751
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Driving, Change at Week 102/ET (n=20)
|
-2.50 scores on a scale
Standard Deviation 14.075
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Color Vision, Change at Week 102/ET (n=57)
|
3.07 scores on a scale
Standard Deviation 20.084
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Peripheral Vision, Change at Week 102/ET (n=59)
|
5.08 scores on a scale
Standard Deviation 19.575
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 102 or ETPopulation: SAS;N=participants with evaluable data; n=participants with evaluable data at specified time point and age group
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.
Outcome measures
| Measure |
Pegaptanib
n=67 eyes
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.
|
|---|---|
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Change From Baseline VA at Final Visit by Age Group
51-64 years, Baseline (n=10)
|
0.797 logMAR
Standard Deviation 0.361
|
|
Change From Baseline VA at Final Visit by Age Group
51-64 years, Change at Week 102/ET (n=10)
|
-0.156 logMAR
Standard Deviation 0.253
|
|
Change From Baseline VA at Final Visit by Age Group
≥ 65 years, Baseline (n=57)
|
0.835 logMAR
Standard Deviation 0.371
|
|
Change From Baseline VA at Final Visit by Age Group
≥ 65 years, Change at Week 102/ET (n=57)
|
-0.121 logMAR
Standard Deviation 0.390
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 102 or ETPopulation: SAS subset of participants with AMD; n=participants with evaluable data at specified time point and stage of AMD
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.
Outcome measures
| Measure |
Pegaptanib
n=66 eyes
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.
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|---|---|
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Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Early Lesion, Baseline (n=34)
|
0.704 logMAR
Standard Deviation 0.332
|
|
Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Early Lesion, Change at Week 102/ET (n=34)
|
-0.066 logMAR
Standard Deviation 0.395
|
|
Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Late Stage Lesion, Baseline (n=31)
|
0.961 logMAR
Standard Deviation 0.358
|
|
Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Late Stage Lesion, Change at Week 102/ET (n=31)
|
-0.190 logMAR
Standard Deviation 0.348
|
|
Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Other AMD Stage, Baseline (n=1)
|
1.301 logMAR
Standard Deviation NA
Not Available (NA): only 1 participant with data
|
|
Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Other AMD Stage, Change at Week 102/ET (n=1)
|
-0.301 logMAR
Standard Deviation NA
Only 1 participant with data
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 102 or ETPopulation: 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
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.
Outcome measures
| Measure |
Pegaptanib
n=67 eyes
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.
|
|---|---|
|
Change From Baseline VA at the Final Visit by Previous Treatment of AMD
No Previous AMD Treatment, Baseline (n=62)
|
0.838 scores on a scale
Standard Deviation 0.363
|
|
Change From Baseline VA at the Final Visit by Previous Treatment of AMD
No Previous Treatment, Change at Week 102/ET(n=62)
|
-0.126 scores on a scale
Standard Deviation 0.367
|
|
Change From Baseline VA at the Final Visit by Previous Treatment of AMD
Previous AMD Treatment, Baseline (n=5)
|
0.724 scores on a scale
Standard Deviation 0.438
|
|
Change From Baseline VA at the Final Visit by Previous Treatment of AMD
Previous Treatment, Change at Week 102/ET (n=5)
|
-0.120 scores on a scale
Standard Deviation 0.461
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 6 weeks up to Week 102Population: SAS
Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.
Outcome measures
| Measure |
Pegaptanib
n=85 Participants
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.
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|---|---|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 6
|
8 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 12
|
7 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 18
|
6 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 24
|
7 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 30
|
11 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 36
|
4 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 42
|
3 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 48
|
4 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 54
|
2 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 60
|
4 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 66
|
2 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 72
|
0 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 78
|
0 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 84
|
1 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 90
|
1 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 96
|
0 participants
|
|
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Week 102
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 6 weeks up to Week 102Population: SAS
Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.
Outcome measures
| Measure |
Pegaptanib
n=85 Participants
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.
|
|---|---|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 6
|
32 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 12
|
35 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 18
|
34 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 24
|
31 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 30
|
24 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 36
|
26 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 42
|
21 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 48
|
17 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 54
|
16 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 60
|
16 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 66
|
10 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 72
|
6 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 78
|
0 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 84
|
7 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 90
|
5 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 96
|
1 participants
|
|
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Week 102
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Every 6 weeks up to Week 102Population: SAS
Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.
Outcome measures
| Measure |
Pegaptanib
n=85 Participants
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.
|
|---|---|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 6
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 12
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 18
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 24
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 30
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 36
|
1 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 42
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 48
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 54
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 60
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 66
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 72
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 78
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 84
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 90
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 96
|
0 participants
|
|
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Week 102
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline through Week 102Population: SAS
Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).
Outcome measures
| Measure |
Pegaptanib
n=85 Participants
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.
|
|---|---|
|
Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Week 102 or ETPopulation: SAS; N=participants with evaluable data at baseline; n=participants with evaluable data at specified time point
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.
Outcome measures
| Measure |
Pegaptanib
n=78 eyes
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.
|
|---|---|
|
Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)
Baseline (n=78)
|
15.0 millimeters of mercury (mmHg)
Standard Deviation 3.2
|
|
Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)
Pre-dose, Change at Week 102/ET (n=74)
|
0.3 millimeters of mercury (mmHg)
Standard Deviation 2.7
|
|
Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)
Post-dose, Change at Week 102/ET (n=75)
|
0.8 millimeters of mercury (mmHg)
Standard Deviation 3.1
|
Adverse Events
Pegaptanib
Serious adverse events
| Measure |
Pegaptanib
n=85 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Intestinal polyp
|
1.2%
1/85
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.
|
Other adverse events
| Measure |
Pegaptanib
n=85 participants at risk
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.
|
|---|---|
|
Eye disorders
Retinal tear
|
1.2%
1/85
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.
|
|
Eye disorders
Uveitis
|
1.2%
1/85
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.
|
|
General disorders
Asthenia
|
1.2%
1/85
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.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
1.2%
1/85
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.
|
|
Nervous system disorders
Dizziness
|
1.2%
1/85
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.
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/85
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER