Age-related Macular Degeneration
Conditions
Keywords
Ophthalmology, Age-related macular degeneration, outpatients
Brief summary
To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.
Detailed description
no sampling
Interventions
OTHERno intervention
Outpatients with age-related macular degeneration (AMD)
Sponsors
Pfizer
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age over 18 years old * patients with neovascular age-related macular degeneration * enrollment to study is fully on physician decision in compliance with current SPC
Exclusion criteria
* Patient who did not meet indication according to SPC Macugen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Acuity (VA) at Final Visit | Baseline, Final Visit (Week 104 or early termination [ET]) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Acuity (VA) at Each Visit | Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 | 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. |
| Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 | 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. |
| Physician's Assessment of Efficacy | Week 104 or End of study (EOS) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102 | 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. |
| Physician's Assessment of Tolerability | Baseline up to Week 104 (EOS) | 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. |
| Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs) | Baseline up to Week 104 (EOS) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. |
| Duration of Treatment | Baseline up to Week 104 (EOS) | 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. |
| Mean Number of Doses of Study Medication Received | Baseline up to Week 104 (EOS) | — |
Countries
Czechia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 108 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Budget exhausted/exceeded | 1 |
| Overall Study | Inactive disease | 5 |
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | No health insurance reimbursement | 2 |
| Overall Study | Objective progression or relapse | 30 |
| Overall Study | Stabilized disease findings | 3 |
| Overall Study | Unresponsiveness to visit invitation | 1 |
| Overall Study | Withdrawal by Subject | 15 |
Baseline characteristics
| Characteristic | Pegaptanib |
|---|---|
| Age, Continuous | 75.8 years STANDARD_DEVIATION 8.3 |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 22 / 108 |
| serious Total, serious adverse events | 2 / 108 |
Outcome results
Primary
Change From Baseline in Visual Acuity (VA) at Final Visit
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Final Visit | Baseline | 0.61 logMAR | Standard Deviation 0.27 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Final Visit | Change at Final visit | 0.15 logMAR | Standard Deviation 0.37 |
Secondary
Change From Baseline in Visual Acuity (VA) at Each Visit
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.
Time frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 6 (n=93) | -0.03 logMAR | Standard Deviation 0.13 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 12 (n=88) | 0.03 logMAR | Standard Deviation 0.23 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 18 (n=76) | 0.03 logMAR | Standard Deviation 0.27 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 24 (n=75) | 0.01 logMAR | Standard Deviation 0.27 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 30 (n=74) | 0.03 logMAR | Standard Deviation 0.26 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 36 (n=68) | 0.02 logMAR | Standard Deviation 0.29 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 42 (n=59) | 0.06 logMAR | Standard Deviation 0.28 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 48 (n=68) | 0.10 logMAR | Standard Deviation 0.35 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 54 (n=50) | 0.09 logMAR | Standard Deviation 0.35 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 60 (n=46) | 0.10 logMAR | Standard Deviation 0.35 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 66 (n=25) | 0.10 logMAR | Standard Deviation 0.41 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 72 (n=19) | 0.14 logMAR | Standard Deviation 0.51 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 78 (n=20) | 0.19 logMAR | Standard Deviation 0.37 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 84 (n=13) | 0.05 logMAR | Standard Deviation 0.35 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 90 (n=16) | -0.05 logMAR | Standard Deviation 0.24 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 96 (n=11) | -0.10 logMAR | Standard Deviation 0.28 |
| Pegaptanib | Change From Baseline in Visual Acuity (VA) at Each Visit | Change at Week 102 (n=20) | 0.16 logMAR | Standard Deviation 0.37 |
Secondary
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
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.
Time frame: Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 6: Improved (n=90) | 20 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 6: Unchanged (n=90) | 64 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 6: Worsened (n=90) | 6 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 12: Improved (n=88) | 12 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 12: Unchanged (n=88) | 58 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 12: Worsened (n=88) | 18 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 18: Improved (n=72) | 12 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 18: Unchanged (n=72) | 49 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 18: Worsened (n=72) | 11 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 24: Improved (n=73) | 16 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 24: Unchanged (n=73) | 46 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 24: Worsened (n=73) | 11 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 30: Improved (n=74) | 9 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 30: Unchanged (n=74) | 51 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 30: Worsened (n=74) | 14 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 36: Improved (n=68) | 11 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 36: Unchanged (n=68) | 47 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 36: Worsened (n=68) | 10 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 42: Improved (n=59) | 8 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 42: Unchanged (n=59) | 42 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 42: Worsened (n=59) | 9 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 48: Improved (n=68) | 12 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 48: Unchanged (n=68) | 44 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 48: Worsened (n=68) | 12 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 54: Improved (n=50) | 8 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 54: Unchanged (n=50) | 33 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 54: Worsened (n=50) | 9 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 60: Improved (n=46) | 1 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 60: Unchanged (n=46) | 38 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 60: Worsened (n=46) | 7 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 66: Improved (n=25) | 3 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 66: Unchanged (n=25) | 11 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 66: Worsened (n=25) | 11 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 72: Improved (n=18) | 4 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 72: Unchanged (n=18) | 12 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 72: Worsened (n=18) | 2 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 78: Improved (n=20) | 2 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 78: Unchanged (n=20) | 14 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 78: Worsened (n=20) | 4 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 84: Improved (n=13) | 2 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 84: Unchanged (n=13) | 8 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 84: Worsened (n=13) | 3 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 90: Improved (n=16) | 4 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 90: Unchanged (n=16) | 10 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 90: Worsened (n=16) | 2 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 96: Improved (n=11) | 5 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 96: Unchanged (n=11) | 4 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 96: Worsened (n=11) | 2 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 102: Improved (n=20) | 3 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 102: Unchanged (n=20) | 8 participants |
| Pegaptanib | Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination | Week 102: Worsened (n=20) | 9 participants |
Secondary
Physician's Assessment of Efficacy
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.
Time frame: Week 104 or End of study (EOS)
Population: FAS included all enrolled participants who received study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib | Physician's Assessment of Efficacy | Poor | 36 participants |
| Pegaptanib | Physician's Assessment of Efficacy | Excellent | 20 participants |
| Pegaptanib | Physician's Assessment of Efficacy | Very Good | 16 participants |
| Pegaptanib | Physician's Assessment of Efficacy | Good | 24 participants |
| Pegaptanib | Physician's Assessment of Efficacy | Fair | 12 participants |
Other Pre-specified
Duration of Treatment
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.
Time frame: Baseline up to Week 104 (EOS)
Population: Safety analysis set included all enrolled participants who received study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pegaptanib | Duration of Treatment | 50.33 weeks | Standard Deviation 29.4 |
Other Pre-specified
Mean Number of Doses of Study Medication Received
Time frame: Baseline up to Week 104 (EOS)
Population: Safety analysis set included all enrolled participants who received study medication.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pegaptanib | Mean Number of Doses of Study Medication Received | 7.48 doses | Standard Deviation 3.77 |
Other Pre-specified
Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to Week 104 (EOS)
Population: Safety analysis set included all enrolled participants who received study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegaptanib | Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs) | 3 participants |
Other Pre-specified
Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
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.
Time frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Baseline: Diagnosis,OCT (n=87) | 85 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Baseline: Diagnosis,FA (n=87) | 61 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Baseline: Diagnosis,Ot (n=87) | 12 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Baseline: Monitoring,OCT (n=25) | 25 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Baseline: Monitoring,FA (n=25) | 6 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Baseline: Monitoring,Ot (n=25) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 6: Monitoring,OCT (n=21) | 21 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 12: Monitoring,OCT (n=32) | 32 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 18: Monitoring,OCT (n=20) | 20 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 18: Monitoring,Ot (n=20) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 24: Monitoring,OCT (n=23) | 23 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 24: Monitoring,FA (n=23) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 24: Monitoring,Ot (n=23) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 30: Monitoring,OCT (n=20) | 20 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 30: Monitoring,Ot (n=20) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 36: Monitoring,OCT (n=21) | 20 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 36: Monitoring,Ot (n=21) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 42: Monitoring,OCT (n=14) | 14 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 48: Monitoring,OCT (n=19) | 19 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 54: Diagnosis,OCT (n=2) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 54: Diagnosis,FA (n=2) | 2 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 54: Monitoring,OCT (n=18) | 18 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 54: Monitoring,FA (n=18) | 2 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 60: Monitoring,OCT (n=13) | 13 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 60: Monitoring,FA (n=13) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 60: Monitoring,Ot (n=13) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 66: Monitoring,OCT (n=3) | 3 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 72: Monitoring,OCT (n=6) | 6 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 72: Monitoring,Ot (n=6) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 78: Monitoring,OCT (n=10) | 10 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 78: Monitoring,Ot (n=10) | 2 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 84: Monitoring,OCT (n=11) | 10 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 84: Monitoring,FA (n=11) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 84: Monitoring,Ot (n=11) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 90: Diagnosis,OCT (n=1) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 90: Diagnosis,Ot (n=1) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 90: Monitoring,OCT (n=10) | 10 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 90: Monitoring,Ot (n=10) | 5 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 96: Monitoring,OCT (n=8) | 8 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 96: Monitoring,Ot (n=8) | 2 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 102: Diagnosis,OCT (n=1) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 102: Diagnosis,FA (n=1) | 1 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 102: Monitoring,OCT (n=17) | 12 participants |
| Pegaptanib | Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring | Week 102: Monitoring,FA (n=17) | 1 participants |
| Pegaptanib | 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
Physician's Assessment of Tolerability
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.
Time frame: Baseline up to Week 104 (EOS)
Population: Safety analysis set included all enrolled participants who received study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib | Physician's Assessment of Tolerability | Excellent | 64 participants |
| Pegaptanib | Physician's Assessment of Tolerability | Very Good | 34 participants |
| Pegaptanib | Physician's Assessment of Tolerability | Good | 8 participants |
| Pegaptanib | Physician's Assessment of Tolerability | Fair | 2 participants |
| Pegaptanib | Physician's Assessment of Tolerability | Poor | 0 participants |