Neovascular Age-related Macular Degeneration
Conditions
Keywords
efficacy and safety of Macugen in routine clinical practice
Brief summary
Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.
Detailed description
Eligible patients in routine clinical practice
Interventions
pegaptanib sodium intravitreal injection every 6 weeks for 2 years
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
adults with neovascular age-related macula degeneration
Exclusion criteria
according to SmPC
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Visual Acuity (VA) at the Final Visit | Baseline, Week 102 or Early Termination (ET) | VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline VA at Each Visit | Baseline, every 6 weeks up to Week 102 | VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. |
| Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED) | Baseline, Week 102 or ET | VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the Pigment Epithelial Detachment (PED) present box ticked at Baseline Visit. |
| Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit | Baseline, Month 6, 12, 18, and 24 | Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning. |
| Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit | Baseline, Week 102 or ET | Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning. |
| Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit | Baseline, Week 102 or ET | Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study | Baseline through Week 102 | Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs). |
| Change From Baseline VA at Final Visit by Age Group | Baseline, Week 102 or ET | Participant population (by age group) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by age group (51 to 64 years, greater than or equal to \[\>=\] 65 years) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA. |
| Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection) | Baseline and Week 102 or ET | IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline. |
| Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage | Baseline, Week 102 or ET | Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA. |
| Change From Baseline VA at the Final Visit by Previous Treatment of AMD | Baseline, Week 102 or ET | Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA. |
| Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Every 6 weeks up to Week 102 | Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment. |
| Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Every 6 weeks up to Week 102 | Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment. |
| Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Every 6 weeks up to Week 102 | Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment. |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 85 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 26 |
| Overall Study | Other | 10 |
| Overall Study | Participant refused | 40 |
Baseline characteristics
| Characteristic | Pegaptanib |
|---|---|
| Age Continuous | 74.0 years STANDARD_DEVIATION 6.8 |
| 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 |
| 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 |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline Distance Activities (n=85) | 58.73 scores on a scale STANDARD_DEVIATION 28.264 |
| 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 |
| 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 |
| 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 |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline Mental Health (n=85) | 50.51 scores on a scale STANDARD_DEVIATION 24.056 |
| 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 |
| 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 |
| 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 |
| 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 |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline Social Functioning (n=85) | 72.35 scores on a scale STANDARD_DEVIATION 28.809 |
| Procedures used for age-related macular degeneration (AMD) diagnosis fluorescein angiography | 66 participants |
| Procedures used for age-related macular degeneration (AMD) diagnosis indocyanine green angiography | 0 participants |
| Procedures used for age-related macular degeneration (AMD) diagnosis optical coherence tomography | 18 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 85 |
| serious Total, serious adverse events | 1 / 85 |
Outcome results
Primary
Change From Baseline Visual Acuity (VA) at the Final Visit
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Time frame: Baseline, Week 102 or Early Termination (ET)
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | Change From Baseline Visual Acuity (VA) at the Final Visit | Baseline | 0.829 logMAR | Standard Deviation 0.367 |
| Pegaptanib | Change From Baseline Visual Acuity (VA) at the Final Visit | Change at Week 102/ET | -0.126 logMAR | Standard Deviation 0.371 |
p-value: 0.0072paired t-test
Secondary
Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Time frame: Baseline, Month 6, 12, 18, and 24
Population: SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit | Change at Month 12 (n=13) | 4.22 scores on a scale | Standard Deviation 9.596 |
| Pegaptanib | Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit | Change at Month 18 (n=4) | -2.33 scores on a scale | Standard Deviation 1.549 |
| Pegaptanib | 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 |
Comparison: Change at Month 6p-value: 0.297paired t-test
Comparison: Change at Month 12p-value: 0.1392paired t-test
Comparison: Change at Month 18p-value: 0.0573paired t-test
Comparison: Change at Month 24p-value: 0.7625paired t-test
Secondary
Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Time frame: Baseline, Week 102 or ET
Population: SAS; N=participants with evaluable data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit | Baseline | 69.47 scores on a scale | Standard Deviation 21.62 |
| Pegaptanib | 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 |
p-value: 0.2759paired t-test
Secondary
Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.
Time frame: Baseline, Week 102 or ET
Population: SAS; N=participants with evaluable data; n=participants with evaluable data at specified time point and item in questionnaire
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
Secondary
Change From Baseline VA at Each Visit
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Time frame: Baseline, every 6 weeks up to Week 102
Population: SAS; Number of participants analyzed (N)=participants with evaluable data; n=participants with evaluable data at specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 12 (n=56) | -0.10 logMAR | Standard Deviation 0.297 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 18 (n=48) | -0.12 logMAR | Standard Deviation 0.374 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 24 (n=43) | -0.16 logMAR | Standard Deviation 0.406 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 30 (n=37) | -0.16 logMAR | Standard Deviation 0.415 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 36 (n=31) | -0.17 logMAR | Standard Deviation 0.416 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 42 (n=28) | -0.12 logMAR | Standard Deviation 0.455 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 48 (n=25) | -0.13 logMAR | Standard Deviation 0.472 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 54 (n=23) | -0.07 logMAR | Standard Deviation 0.461 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 96 (n=2) | 0.33 logMAR | Standard Deviation 0.213 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 102 (n=2) | 0.33 logMAR | Standard Deviation 0.213 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 60 (n=19) | -0.09 logMAR | Standard Deviation 0.5 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 66 (n=13) | 0.04 logMAR | Standard Deviation 0.558 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 72 (n=10) | 0.05 logMAR | Standard Deviation 0.495 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 84 (n=8) | -0.04 logMAR | Standard Deviation 0.302 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 90 (n=4) | -0.11 logMAR | Standard Deviation 0.334 |
| Pegaptanib | Change From Baseline VA at Each Visit | Change at Week 6 (n=59) | -0.07 logMAR | Standard Deviation 0.249 |
Comparison: Change from baseline at Week 6p-value: 0.0433paired t-test
Comparison: Change from baseline at Week 12p-value: 0.0133paired t-test
Comparison: Change from baseline at Week 18p-value: 0.0278paired t-test
Comparison: Change from baseline at Week 24p-value: 0.016paired t-test
Comparison: Change from baseline at Week 30p-value: 0.0264paired t-test
Comparison: Change from baseline at Week 36p-value: 0.0278paired t-test
Comparison: Change from baseline at Week 42p-value: 0.1854paired t-test
Comparison: Change from baseline at Week 48p-value: 0.1684paired t-test
Comparison: Change from baseline at Week 54p-value: 0.4718paired t-test
Comparison: Change from baseline at Week 60p-value: 0.434paired t-test
Comparison: Change from baseline at Week 66p-value: 0.7765paired t-test
Comparison: Change from baseline at Week 72p-value: 0.7544paired t-test
Comparison: Change from baseline at Week 84p-value: 0.7201paired t-test
Comparison: Change from baseline at Week 90p-value: 0.5692paired t-test
Comparison: Change from baseline at Week 96p-value: 0.2749paired t-test
Comparison: Change from baseline at Week 102p-value: 0.2749paired t-test
Secondary
Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the Pigment Epithelial Detachment (PED) present box ticked at Baseline Visit.
Time frame: Baseline, Week 102 or ET
Population: SAS subset of participants with RPED at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | 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 |
| Pegaptanib | 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 |
Other Pre-specified
Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)
IOP was measured using either applanation or tonopen before intravitreal injection, reported as pre-dose and post-dose pressure. IOP valid range: 10-21 mmHg. Change: IOP at Visit X minus IOP at Baseline.
Time frame: Baseline and Week 102 or ET
Population: SAS; N=participants with evaluable data at baseline; n=participants with evaluable data at specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
Other Pre-specified
Change From Baseline VA at Final Visit by 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.
Time frame: Baseline, Week 102 or ET
Population: SAS;N=participants with evaluable data; n=participants with evaluable data at specified time point and age group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | Change From Baseline VA at Final Visit by Age Group | 51-64 years, Baseline (n=10) | 0.797 logMAR | Standard Deviation 0.361 |
| Pegaptanib | 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 |
| Pegaptanib | Change From Baseline VA at Final Visit by Age Group | ≥ 65 years, Baseline (n=57) | 0.835 logMAR | Standard Deviation 0.371 |
| Pegaptanib | Change From Baseline VA at Final Visit by Age Group | ≥ 65 years, Change at Week 102/ET (n=57) | -0.121 logMAR | Standard Deviation 0.39 |
Other Pre-specified
Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
Participant population (by AMD stage) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by AMD stage (early lesion, late stage lesion, other) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
Time frame: Baseline, Week 102 or ET
Population: SAS subset of participants with AMD; n=participants with evaluable data at specified time point and stage of AMD
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage | Other AMD Stage, Baseline (n=1) | 1.301 logMAR | — |
| Pegaptanib | 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 | — |
Other Pre-specified
Change From Baseline VA at the Final Visit by Previous Treatment of AMD
Participant population (by previous treatment of AMD) that benefited more from Pegaptanib treatment based on change from baseline VA at final visit. VA measured by previous AMD treatment (yes/no) using ETDRS chart at 4 meter distance, at 1 meter distance (if participant's VA was poor) or verifying if participant able only to count fingers, perceive hand motion, or light. VA expressed as logMAR could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in logMAR scale represents improvement in VA.
Time frame: Baseline, Week 102 or ET
Population: SAS subset of participants for who data was collected about previous AMD treatment (yes/no); n=number of participants with evaluable data at specified time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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 |
| Pegaptanib | 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
Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
Participant counts by type of diagnostic procedure (fluorescein angiography) used to monitor AMD treatment.
Time frame: Every 6 weeks up to Week 102
Population: SAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 6 | 8 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 12 | 7 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 18 | 6 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 24 | 7 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 30 | 11 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 36 | 4 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 42 | 3 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 48 | 4 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 54 | 2 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 60 | 4 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 66 | 2 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 72 | 0 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 78 | 0 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 84 | 1 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 90 | 1 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 96 | 0 participants |
| Pegaptanib | Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment | Week 102 | 1 participants |
Other Pre-specified
Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
Participant counts by type of diagnostic procedure (indocyanine green angiography) used to monitor AMD treatment.
Time frame: Every 6 weeks up to Week 102
Population: SAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 6 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 12 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 18 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 24 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 30 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 36 | 1 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 42 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 48 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 54 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 60 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 66 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 72 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 78 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 84 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 90 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 96 | 0 participants |
| Pegaptanib | Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment | Week 102 | 0 participants |
Other Pre-specified
Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
Participant counts by type of diagnostic procedure (optical coherence tomography) used to monitor AMD treatment.
Time frame: Every 6 weeks up to Week 102
Population: SAS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 6 | 32 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 12 | 35 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 18 | 34 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 24 | 31 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 30 | 24 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 36 | 26 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 42 | 21 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 48 | 17 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 54 | 16 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 60 | 16 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 66 | 10 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 72 | 6 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 78 | 0 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 84 | 7 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 90 | 5 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 96 | 1 participants |
| Pegaptanib | Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment | Week 102 | 1 participants |
Other Pre-specified
Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study
Participants with dose reduction or temporary discontinuation of treatment due to adverse events (AEs).
Time frame: Baseline through Week 102
Population: SAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pegaptanib | Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study | 3 participants |