Trial Outcomes & Findings for Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice (NCT NCT00787319)
NCT ID: NCT00787319
Last Updated: 2018-12-06
Results Overview
Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.
Recruitment status
COMPLETED
Target enrollment
108 participants
Primary outcome timeframe
Baseline, Final Visit (Week 104 or early termination [ET])
Results posted on
2018-12-06
Participant Flow
Participant milestones
| Measure |
Pegaptanib
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
63
|
Reasons for withdrawal
| Measure |
Pegaptanib
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
15
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Objective progression or relapse
|
30
|
|
Overall Study
Lack of Efficacy
|
1
|
|
Overall Study
Budget exhausted/exceeded
|
1
|
|
Overall Study
Unresponsiveness to visit invitation
|
1
|
|
Overall Study
No health insurance reimbursement
|
2
|
|
Overall Study
Stabilized disease findings
|
3
|
|
Overall Study
Inactive disease
|
5
|
Baseline Characteristics
Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice
Baseline characteristics by cohort
| Measure |
Pegaptanib
n=108 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Age, Continuous
|
75.8 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Final Visit (Week 104 or early termination [ET])Population: Full analysis set (FAS) included all enrolled participants who received study medication. Missing values were imputed using last observation carried forward (LOCF) method.
Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.
Outcome measures
| Measure |
Pegaptanib
n=108 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Visual Acuity (VA) at Final Visit
Baseline
|
0.61 logMAR
Standard Deviation 0.27
|
|
Change From Baseline in Visual Acuity (VA) at Final Visit
Change at Final visit
|
0.15 logMAR
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102Population: FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies participants evaluated at each time point, respectively.
VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.
Outcome measures
| Measure |
Pegaptanib
n=93 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 6 (n=93)
|
-0.03 logMAR
Standard Deviation 0.13
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 12 (n=88)
|
0.03 logMAR
Standard Deviation 0.23
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 18 (n=76)
|
0.03 logMAR
Standard Deviation 0.27
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 24 (n=75)
|
0.01 logMAR
Standard Deviation 0.27
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 30 (n=74)
|
0.03 logMAR
Standard Deviation 0.26
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 36 (n=68)
|
0.02 logMAR
Standard Deviation 0.29
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 42 (n=59)
|
0.06 logMAR
Standard Deviation 0.28
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 48 (n=68)
|
0.10 logMAR
Standard Deviation 0.35
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 54 (n=50)
|
0.09 logMAR
Standard Deviation 0.35
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 60 (n=46)
|
0.10 logMAR
Standard Deviation 0.35
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 66 (n=25)
|
0.10 logMAR
Standard Deviation 0.41
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 72 (n=19)
|
0.14 logMAR
Standard Deviation 0.51
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 78 (n=20)
|
0.19 logMAR
Standard Deviation 0.37
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 84 (n=13)
|
0.05 logMAR
Standard Deviation 0.35
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 90 (n=16)
|
-0.05 logMAR
Standard Deviation 0.24
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 96 (n=11)
|
-0.10 logMAR
Standard Deviation 0.28
|
|
Change From Baseline in Visual Acuity (VA) at Each Visit
Change at Week 102 (n=20)
|
0.16 logMAR
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102Population: FAS included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies participants evaluated at each time point, respectively.
VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.
Outcome measures
| Measure |
Pegaptanib
n=90 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 60: Improved (n=46)
|
1 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 6: Improved (n=90)
|
20 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 6: Unchanged (n=90)
|
64 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 6: Worsened (n=90)
|
6 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 12: Improved (n=88)
|
12 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 12: Unchanged (n=88)
|
58 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 12: Worsened (n=88)
|
18 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 18: Improved (n=72)
|
12 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 18: Unchanged (n=72)
|
49 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 18: Worsened (n=72)
|
11 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 24: Improved (n=73)
|
16 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 24: Unchanged (n=73)
|
46 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 24: Worsened (n=73)
|
11 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 30: Improved (n=74)
|
9 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 30: Unchanged (n=74)
|
51 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 30: Worsened (n=74)
|
14 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 36: Improved (n=68)
|
11 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 36: Unchanged (n=68)
|
47 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 36: Worsened (n=68)
|
10 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 42: Improved (n=59)
|
8 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 42: Unchanged (n=59)
|
42 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 42: Worsened (n=59)
|
9 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 48: Improved (n=68)
|
12 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 48: Unchanged (n=68)
|
44 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 48: Worsened (n=68)
|
12 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 54: Improved (n=50)
|
8 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 54: Unchanged (n=50)
|
33 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 54: Worsened (n=50)
|
9 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 60: Unchanged (n=46)
|
38 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 60: Worsened (n=46)
|
7 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 66: Improved (n=25)
|
3 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 66: Unchanged (n=25)
|
11 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 66: Worsened (n=25)
|
11 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 72: Improved (n=18)
|
4 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 72: Unchanged (n=18)
|
12 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 72: Worsened (n=18)
|
2 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 78: Improved (n=20)
|
2 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 78: Unchanged (n=20)
|
14 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 78: Worsened (n=20)
|
4 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 84: Improved (n=13)
|
2 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 84: Unchanged (n=13)
|
8 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 84: Worsened (n=13)
|
3 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 90: Improved (n=16)
|
4 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 90: Unchanged (n=16)
|
10 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 90: Worsened (n=16)
|
2 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 96: Improved (n=11)
|
5 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 96: Unchanged (n=11)
|
4 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 96: Worsened (n=11)
|
2 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 102: Improved (n=20)
|
3 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 102: Unchanged (n=20)
|
8 participants
|
|
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
Week 102: Worsened (n=20)
|
9 participants
|
SECONDARY outcome
Timeframe: Week 104 or End of study (EOS)Population: FAS included all enrolled participants who received study medication.
Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.
Outcome measures
| Measure |
Pegaptanib
n=108 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Physician's Assessment of Efficacy
Excellent
|
20 participants
|
|
Physician's Assessment of Efficacy
Very Good
|
16 participants
|
|
Physician's Assessment of Efficacy
Good
|
24 participants
|
|
Physician's Assessment of Efficacy
Fair
|
12 participants
|
|
Physician's Assessment of Efficacy
Poor
|
36 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102Population: Safety analysis set included all enrolled participants who received study medication. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. 'n' signifies participants evaluated at each time point, respectively.
Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.
Outcome measures
| Measure |
Pegaptanib
n=87 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Baseline: Diagnosis,OCT (n=87)
|
85 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Baseline: Diagnosis,FA (n=87)
|
61 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Baseline: Diagnosis,Ot (n=87)
|
12 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Baseline: Monitoring,OCT (n=25)
|
25 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Baseline: Monitoring,FA (n=25)
|
6 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Baseline: Monitoring,Ot (n=25)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 6: Monitoring,OCT (n=21)
|
21 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 12: Monitoring,OCT (n=32)
|
32 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 18: Monitoring,OCT (n=20)
|
20 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 18: Monitoring,Ot (n=20)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 24: Monitoring,OCT (n=23)
|
23 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 24: Monitoring,FA (n=23)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 24: Monitoring,Ot (n=23)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 30: Monitoring,OCT (n=20)
|
20 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 30: Monitoring,Ot (n=20)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 36: Monitoring,OCT (n=21)
|
20 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 36: Monitoring,Ot (n=21)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 42: Monitoring,OCT (n=14)
|
14 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 48: Monitoring,OCT (n=19)
|
19 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 54: Diagnosis,OCT (n=2)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 54: Diagnosis,FA (n=2)
|
2 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 54: Monitoring,OCT (n=18)
|
18 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 54: Monitoring,FA (n=18)
|
2 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 60: Monitoring,OCT (n=13)
|
13 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 60: Monitoring,FA (n=13)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 60: Monitoring,Ot (n=13)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 66: Monitoring,OCT (n=3)
|
3 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 72: Monitoring,OCT (n=6)
|
6 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 72: Monitoring,Ot (n=6)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 78: Monitoring,OCT (n=10)
|
10 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 78: Monitoring,Ot (n=10)
|
2 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 84: Monitoring,OCT (n=11)
|
10 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 84: Monitoring,FA (n=11)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 84: Monitoring,Ot (n=11)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 90: Diagnosis,OCT (n=1)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 90: Diagnosis,Ot (n=1)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 90: Monitoring,OCT (n=10)
|
10 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 90: Monitoring,Ot (n=10)
|
5 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 96: Monitoring,OCT (n=8)
|
8 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 96: Monitoring,Ot (n=8)
|
2 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 102: Diagnosis,OCT (n=1)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 102: Diagnosis,FA (n=1)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 102: Monitoring,OCT (n=17)
|
12 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 102: Monitoring,FA (n=17)
|
1 participants
|
|
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
Week 102: Monitoring,Ot (n=17)
|
11 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 104 (EOS)Population: Safety analysis set included all enrolled participants who received study medication.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Outcome measures
| Measure |
Pegaptanib
n=108 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)
|
3 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 104 (EOS)Population: Safety analysis set included all enrolled participants who received study medication.
Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.
Outcome measures
| Measure |
Pegaptanib
n=108 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Duration of Treatment
|
50.33 weeks
Standard Deviation 29.40
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 104 (EOS)Population: Safety analysis set included all enrolled participants who received study medication.
Outcome measures
| Measure |
Pegaptanib
n=108 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Mean Number of Doses of Study Medication Received
|
7.48 doses
Standard Deviation 3.77
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to Week 104 (EOS)Population: Safety analysis set included all enrolled participants who received study medication.
Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.
Outcome measures
| Measure |
Pegaptanib
n=108 Participants
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Physician's Assessment of Tolerability
Excellent
|
64 participants
|
|
Physician's Assessment of Tolerability
Very Good
|
34 participants
|
|
Physician's Assessment of Tolerability
Good
|
8 participants
|
|
Physician's Assessment of Tolerability
Fair
|
2 participants
|
|
Physician's Assessment of Tolerability
Poor
|
0 participants
|
Adverse Events
Pegaptanib
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pegaptanib
n=108 participants at risk
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Eye disorders
Choroidal neovascularisation
|
0.93%
1/108
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.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.93%
1/108
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.
|
Other adverse events
| Measure |
Pegaptanib
n=108 participants at risk
Participants with neovascular age-related macular degeneration (AMD) received pegaptanib intravitreal injection in accordance with Summary of Product Characteristics (SmPC) and observed for a period of up to 24 months or early discontinuation.
|
|---|---|
|
Eye disorders
Age-related macular degeneration
|
3.7%
4/108
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.
|
|
Eye disorders
Choroidal neovascularisation
|
2.8%
3/108
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.
|
|
Eye disorders
Conjunctivitis
|
3.7%
4/108
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.
|
|
Eye disorders
Corneal erosion
|
0.93%
1/108
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.
|
|
Eye disorders
Glaucoma
|
0.93%
1/108
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.
|
|
Eye disorders
Macular oedema
|
0.93%
1/108
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.
|
|
Eye disorders
Retinal haemorrhage
|
1.9%
2/108
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.
|
|
Eye disorders
Subretinal fibrosis
|
0.93%
1/108
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.
|
|
General disorders
Drug ineffective
|
0.93%
1/108
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.
|
|
General disorders
Granuloma
|
0.93%
1/108
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.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.93%
1/108
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.
|
|
Infections and infestations
Keratitis herpetic
|
0.93%
1/108
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.
|
|
Infections and infestations
Oral herpes
|
0.93%
1/108
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.
|
|
Infections and infestations
Viral infection
|
0.93%
1/108
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.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.93%
1/108
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.
|
|
Nervous system disorders
Dizziness
|
0.93%
1/108
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.
|
|
Surgical and medical procedures
Therapeutic embolisation
|
0.93%
1/108
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.
|
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