Age-related Macular Degeneration, Macular Degeneration, Neovascular Macular Degeneration
Conditions
Keywords
prospective, observational, Phase 4, non-interventional, open-label
Brief summary
Long-term observational study to assess the safety, efficacy and quality of life of patients with neovascular age-related macular degeneration (AMD) under Macugen treatment.
Detailed description
Ophthalmologists who are experienced in doing intravitreal injections in Germany
Interventions
DRUGPegaptanib
Dosage recommendations for MACUGEN took place on the basis of the approved Summary of Product Characteristics (SmPC) and were adjusted solely according to medical practice. MACUGEN® is available as pre-filled syringe containing 0.3 mg MACUGEN® in 90 µL injection solution for intravitreal injection. Macugen injections were documented to reflect the routine clinical practice. Follow-up visits were only carried out and documented if they took place as part of the standard medical treatment for the respective case and were necessary for medical and/or therapeutic reasons.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with neovascular age-related macular degeneration
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Angiographic Subtype Reported at Last Visit | Month 24 or early termination | Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value. |
| Number of Participants With Angiographic Subtype Reported at Week 24 | Week 24 | Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Number of Participants With Angiographic Subtype Reported at Week 30 | Week 30 | Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Number of Participants With Angiographic Subtype Reported at Week 36 | Week 36 | Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Number of Participants With Angiographic Subtype Reported at Week 42 | Week 42 | Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Number of Participants With Angiographic Subtype Reported at Week 48 | Week 48 | Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Number of Participants With Angiographic Subtype Reported at Week 54 | Week 54 | Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Visual Acuity (VA) | Baseline, every 6 weeks up to Month 24 or early termination | VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study \[EDTRS\]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection). |
| Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Baseline, every 6 months up to Month 24 or early termination | Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10. |
| Number of Participants With Investigator Assessments of Efficacy | Month 24 or early termination | Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor. |
| Lesion Size (Number of Optic Disc Areas) | Baseline, every 6 weeks up to Month 24 or early termination | Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm\^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection). |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 | Week 6 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 | Week 12 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 | Week 18 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 | Week 24 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 | Week 30 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 | Week 36 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 42 | Week 42 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 48 | Week 48 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 54 | Week 54 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 60 | Week 60 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 66 | Week 66 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Week 72 | Week 72 | Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. |
| Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit | Month 24 or early termination | Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value. |
| Number of Participants With Pigment Epithelial Detachment (PED) at Baseline | Baseline | PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 6 | Week 6 | PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 12 | Week 12 | PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 18 | Week 18 | PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 24 | Week 24 | PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 30 | Week 30 | PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 36 | Week 36 | PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 42 | Week 42 | PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 48 | Week 48 | PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Week 54 | Week 54 | PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. |
| Number of Participants With PED at Last Visit | Month 24 or early termination | PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value. |
| Central Retinal Thickness | Baseline, every 6 weeks up to Month 24 or early termination | Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection). |
| Number of Participants With Angiographic Subtype Reported at Baseline | Baseline | Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Number of Participants With Angiographic Subtype Reported at Week 6 | Week 6 | Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Number of Participants With Angiographic Subtype Reported at Week 12 | Week 12 | Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
| Number of Participants With Angiographic Subtype Reported at Week 18 | Week 18 | Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Complications Associated With Injection | Baseline up to Month 24 or early termination | Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator. |
| Treatment Tolerability | Month 24 or early termination | Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor. |
| Intraocular Pressure (IOP) | Baseline, every 6 weeks up to Month 24 or early termination | IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection. |
| Change in IOP Between Predose and Postdose Assessment | Baseline, every 6 weeks up to Month 24 or early termination | IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP. |
| IOP Mean Difference (Within a Participant) | Baseline, every 6 weeks up to Month 24 or early termination | Average predose minus postdose mean difference in IOP within a participant |
| Time to First Adverse Event (AE) | Baseline up to Month 24 or early termination | Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage. |
Participant flow
Pre-assignment details
This observational study did not define endpoints as primary or secondary. All endpoints arbitrarily assigned as primary for reporting results.
Participants by arm
| Arm | Count |
|---|---|
| Macugen Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs. | 1,001 |
| Total | 1,001 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 9 |
| Overall Study | Death | 3 |
| Overall Study | Lack of Efficacy | 195 |
| Overall Study | Lost to Follow-up | 106 |
| Overall Study | Missing discontinuation status | 369 |
| Overall Study | Other | 131 |
Baseline characteristics
| Characteristic | Macugen |
|---|---|
| Age Continuous | 77.4 years STANDARD_DEVIATION 7.8 |
| Sex/Gender, Customized Female | 666 participants |
| Sex/Gender, Customized Male | 330 participants |
| Sex/Gender, Customized Unspecified | 5 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 12 / 816 |
| serious Total, serious adverse events | 16 / 816 |
Outcome results
Primary
Central Retinal Thickness
Central retinal thickness assessed by Investigator every 6 weeks, as part of SOC, using standard clinical methods practiced (optical coherence tomography) and reported as mean central retinal thickness. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Population: FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macugen | Central Retinal Thickness | Visit 1, Baseline (N=316) | 309.2 Micrometers (Mcm) | Standard Deviation 105.9 |
| Macugen | Central Retinal Thickness | Visit 3, Week 6 (N=224) | 305.8 Micrometers (Mcm) | Standard Deviation 111.3 |
| Macugen | Central Retinal Thickness | Visit 4, Week 12 (N=173) | 307.3 Micrometers (Mcm) | Standard Deviation 122.9 |
| Macugen | Central Retinal Thickness | Visit 5, Week 18 (N=205) | 297.8 Micrometers (Mcm) | Standard Deviation 145 |
| Macugen | Central Retinal Thickness | Visit 6, Week 24 (N=33) | 328.9 Micrometers (Mcm) | Standard Deviation 180.5 |
| Macugen | Central Retinal Thickness | Visit 7, Week 30 (N=26) | 272.7 Micrometers (Mcm) | Standard Deviation 67.4 |
| Macugen | Central Retinal Thickness | Visit 8, Week 36 (N=27) | 319.6 Micrometers (Mcm) | Standard Deviation 118.7 |
| Macugen | Central Retinal Thickness | Visit 9, Week 42 (N=13) | 252.9 Micrometers (Mcm) | Standard Deviation 88.8 |
| Macugen | Central Retinal Thickness | Visit 10, Week 48 (N=3) | 312.0 Micrometers (Mcm) | Standard Deviation 133.5 |
| Macugen | Central Retinal Thickness | Last Visit (N=311) | 295.2 Micrometers (Mcm) | Standard Deviation 138.5 |
Primary
Lesion Size (Number of Optic Disc Areas)
Lesion size measured by Investigator after each injection as part of standard of care (SOC), using standard clinical methods practiced (fluorescein or indocyanine green angiography); Reported as the number of optic-disk areas, each of which were 2.54 millimeters squared (mm\^2). Lesion size included choroidal neovascularization, exudation area, and hemorrhage, if present. The timeframe was as follows: Visit 1: before first injection; Visit 3: 6 weeks after first injection (second injection).
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Population: FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 1, Baseline (N=712) | 2.4 number of optic disc areas | Standard Deviation 1.6 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 3, Week 6 (N=190) | 2.1 number of optic disc areas | Standard Deviation 1.2 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 4, Week 12 (N=173) | 2.3 number of optic disc areas | Standard Deviation 1.7 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 5, Week 18 (N=316) | 2.2 number of optic disc areas | Standard Deviation 2 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 6, Week 24 (N=45) | 2.3 number of optic disc areas | Standard Deviation 1.3 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 7, Week 30 (N=45) | 3.2 number of optic disc areas | Standard Deviation 2.1 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 8, Week 36 (N=78) | 2.8 number of optic disc areas | Standard Deviation 2 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 9, Week 42 (N=15) | 2.5 number of optic disc areas | Standard Deviation 1.3 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 10, Week 48 (N=9) | 2.5 number of optic disc areas | Standard Deviation 1.4 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 11, Week 54 (N=6) | 2.3 number of optic disc areas | Standard Deviation 0.8 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 12, Week 60 (N=2) | 2.0 number of optic disc areas | Standard Deviation 1.4 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Visit 13, Week 66 (N=3) | 0.8 number of optic disc areas | Standard Deviation 0.3 |
| Macugen | Lesion Size (Number of Optic Disc Areas) | Last Visit (N=513) | 2.5 number of optic disc areas | Standard Deviation 2.1 |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit
Neovascular membrane activity (measured by leakage) assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity. Last Visit: last available postbaseline value.
Time frame: Month 24 or early termination
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit | Increased | 101 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit | Unchanged | 170 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Last Visit | Decreased | 243 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 12
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 12
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 | Increased | 22 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 | Unchanged | 66 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 12 | Decreased | 85 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 18
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 18
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 | Increased | 57 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 | Unchanged | 83 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 18 | Decreased | 176 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 24
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 24
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 | Increased | 13 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 | Unchanged | 15 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 24 | Decreased | 18 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 30
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 30
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 | Increased | 6 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 | Unchanged | 15 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 30 | Decreased | 24 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 36
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 36
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 | Increased | 11 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 | Unchanged | 21 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 36 | Decreased | 46 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 42
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 42
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 42 | Increased | 3 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 42 | Unchanged | 6 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 42 | Decreased | 6 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 48
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 48
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 48 | Increased | 2 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 48 | Unchanged | 3 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 48 | Decreased | 5 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 54
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 54
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 54 | Increased | 0 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 54 | Unchanged | 2 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 54 | Decreased | 4 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 6
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 6
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 | Increased | 28 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 | Unchanged | 74 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 6 | Decreased | 88 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 60
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 12, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 60
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 60 | Increased | 1 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 60 | Unchanged | 0 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 60 | Decreased | 1 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 66
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 13, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 66
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 66 | Increased | 0 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 66 | Unchanged | 1 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 66 | Decreased | 2 Participants |
Primary
Number of Participants With a Change in Activity of Neovascular Membrane at Week 72
Neovascular membrane activity (measured by leakage) assessed by Investigator at Visit 14, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included increased, unchanged or decreased neovascular membrane activity.
Time frame: Week 72
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 72 | Decreased | 1 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 72 | Increased | 0 Participants |
| Macugen | Number of Participants With a Change in Activity of Neovascular Membrane at Week 72 | Unchanged | 0 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Baseline
Angiographic subtype assessed by Investigator at Baseline, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Baseline
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Baseline | unclear | 76 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Baseline | occult | 363 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Baseline | minimally classic | 113 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Baseline | predominantly classic | 138 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Baseline | pure classic | 26 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Last Visit
Angiographic subtype assessed by Investigator at the Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic). Last Visit: last available postbaseline value.
Time frame: Month 24 or early termination
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Last Visit | unclear | 105 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Last Visit | occult | 251 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Last Visit | minimally classic | 88 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Last Visit | predominantly classic | 58 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Last Visit | pure classic | 12 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 12
Angiographic subtype assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 12
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 12 | unclear | 29 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 12 | occult | 71 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 12 | minimally classic | 21 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 12 | predominantly classic | 50 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 12 | pure classic | 2 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 18
Angiographic subtype assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 18
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 18 | unclear | 68 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 18 | occult | 140 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 18 | minimally classic | 70 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 18 | predominantly classic | 30 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 18 | pure classic | 8 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 24
Angiographic subtype assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 24
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 24 | unclear | 7 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 24 | occult | 26 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 24 | minimally classic | 5 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 24 | predominantly classic | 5 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 24 | pure classic | 2 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 30
Angiographic subtype assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent (%) classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 30
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 30 | unclear | 10 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 30 | occult | 23 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 30 | minimally classic | 8 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 30 | predominantly classic | 3 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 30 | pure classic | 1 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 36
Angiographic subtype assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 36
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 36 | unclear | 5 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 36 | occult | 37 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 36 | minimally classic | 30 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 36 | predominantly classic | 3 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 36 | pure classic | 3 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 42
Angiographic subtype assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 42
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 42 | unclear | 3 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 42 | occult | 10 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 42 | minimally classic | 1 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 42 | predominantly classic | 0 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 42 | pure classic | 1 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 48
Angiographic subtype assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 48
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 48 | unclear | 0 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 48 | occult | 7 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 48 | minimally classic | 3 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 48 | predominantly classic | 0 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 48 | pure classic | 0 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 54
Angiographic subtype assessed by Investigator at Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the % classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 54
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 54 | unclear | 0 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 54 | occult | 3 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 54 | minimally classic | 3 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 54 | predominantly classic | 0 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 54 | pure classic | 0 Participants |
Primary
Number of Participants With Angiographic Subtype Reported at Week 6
Angiographic subtype assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein angiography or indocyanine green angiography) and the percent \[%\] classic fraction categories included unclear, occult (0% classic), minimally classic (1-49% classic), predominantly classic (50-99% classic), and pure classic (100% classic).
Time frame: Week 6
Population: FAS;N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 6 | unclear | 29 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 6 | occult | 81 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 6 | minimally classic | 21 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 6 | predominantly classic | 56 Participants |
| Macugen | Number of Participants With Angiographic Subtype Reported at Week 6 | pure classic | 3 Participants |
Primary
Number of Participants With Investigator Assessments of Efficacy
Investigator's categorical assessment of the efficacy of Macugen (pegaptanib) treatment at the final visit or termination of therapy; Categories included Very Good, Good, Moderate, and Poor.
Time frame: Month 24 or early termination
Population: FAS; N = number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Investigator Assessments of Efficacy | Poor | 174 Participants |
| Macugen | Number of Participants With Investigator Assessments of Efficacy | Very Good | 36 Participants |
| Macugen | Number of Participants With Investigator Assessments of Efficacy | Good | 226 Participants |
| Macugen | Number of Participants With Investigator Assessments of Efficacy | Moderate | 168 Participants |
Primary
Number of Participants With PED at Last Visit
PED assessed by Investigator at Last Visit, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent. Last Visit: last available postbaseline value.
Time frame: Month 24 or early termination
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Last Visit | Present | 87 Participants |
| Macugen | Number of Participants With PED at Last Visit | Absent | 422 Participants |
Primary
Number of Participants With PED at Week 12
PED assessed by Investigator at Visit 4, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 12
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 12 | Present | 32 Participants |
| Macugen | Number of Participants With PED at Week 12 | Absent | 137 Participants |
Primary
Number of Participants With PED at Week 18
PED assessed by Investigator at Visit 5, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 18
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 18 | Present | 45 Participants |
| Macugen | Number of Participants With PED at Week 18 | Absent | 268 Participants |
Primary
Number of Participants With PED at Week 24
PED assessed by Investigator at Visit 6, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 24
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 24 | Present | 7 Participants |
| Macugen | Number of Participants With PED at Week 24 | Absent | 38 Participants |
Primary
Number of Participants With PED at Week 30
PED assessed by Investigator at Visit 7, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 30
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 30 | Present | 11 Participants |
| Macugen | Number of Participants With PED at Week 30 | Absent | 33 Participants |
Primary
Number of Participants With PED at Week 36
PED assessed by Investigator at Visit 8, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 36
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 36 | Present | 11 Participants |
| Macugen | Number of Participants With PED at Week 36 | Absent | 66 Participants |
Primary
Number of Participants With PED at Week 42
PED assessed by Investigator at Visit 9, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 42
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 42 | Present | 3 Participants |
| Macugen | Number of Participants With PED at Week 42 | Absent | 12 Participants |
Primary
Number of Participants With PED at Week 48
PED assessed by Investigator at Visit 10, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 48
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 48 | Present | 6 Participants |
| Macugen | Number of Participants With PED at Week 48 | Absent | 4 Participants |
Primary
Number of Participants With PED at Week 54
PED assessed by Investigator Visit 11, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 54
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 54 | Present | 1 Participants |
| Macugen | Number of Participants With PED at Week 54 | Absent | 5 Participants |
Primary
Number of Participants With PED at Week 6
PED assessed by Investigator at Visit 3, as part of SOC, using standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Week 6
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With PED at Week 6 | Present | 46 Participants |
| Macugen | Number of Participants With PED at Week 6 | Absent | 142 Participants |
Primary
Number of Participants With Pigment Epithelial Detachment (PED) at Baseline
PED assessed by Investigator at baseline as part of SOC for participants with age-related macular degeneration; Standard clinical methods practiced (fluorescein or indocyanine green angiography); Categories included present or absent.
Time frame: Baseline
Population: FAS; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Pigment Epithelial Detachment (PED) at Baseline | Present | 240 Participants |
| Macugen | Number of Participants With Pigment Epithelial Detachment (PED) at Baseline | Absent | 473 Participants |
Primary
Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score
Participant-reported vision-related functioning and quality of life measured using the 25 item NEI-VFQ-25. Converted scale 0-100 where higher score represented better functioning: General Health: item 1; General Vision: item 2; Ocular Pain: 4,19; Near Vision: 5,6,7; Distance Vision: 8,9,14; Social Functioning: 11,13; Mental Health Activities: 3,21,22,25; Role Difficulties: 17,18; Dependency: 20,23,24; Driving: 15c,16, 16a; Color Vision: 12; Peripheral Vision: 10.
Time frame: Baseline, every 6 months up to Month 24 or early termination
Population: FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macugen | Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Visit 1, Baseline (N=485) | 54.05 Scores on a scale | Standard Deviation 23.5 |
| Macugen | Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Visit 2, Month 6 (N=219) | 55.56 Scores on a scale | Standard Deviation 22.17 |
| Macugen | Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Visit 3, Month 12 (N=167) | 57.13 Scores on a scale | Standard Deviation 21.6 |
| Macugen | Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Visit 4, Month 18 (N=135) | 56.95 Scores on a scale | Standard Deviation 20.58 |
| Macugen | Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Visit 5, Month 24 (N=338) | 56.09 Scores on a scale | Standard Deviation 23.73 |
| Macugen | Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25): Overall Composite Score | Last Visit (N=410) | 54.90 Scores on a scale | Standard Deviation 23.86 |
Primary
Visual Acuity (VA)
VA measured at each follow-up visit as the number of lines read on a standard eye chart (Snellen or Early Treatment Diabetic Retinopathy Study \[EDTRS\]) using a 5 meter distance, 1 meter distance, or verifying if participant was able to count fingers, perceive hand motion, or light. Follow-up visits occurred only if considered part of standard medical treatment. The timeframe was as follows: Visit 1: before first injection; Visit 2: first injection; Visit 3: 6 weeks after first injection (second injection).
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Population: Full Analysis Set (FAS):participants who received at least 1 Macugen (pegaptanib) injection and had at least 1 VA measurement postbaseline. Participants with light perception or no light perception any time during study were excluded from FAS; N=participants with evaluable data; Last Visit: last available postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macugen | Visual Acuity (VA) | Visit 1, Baseline (N=812) | 8.51 lines of VA | Standard Deviation 5.03 |
| Macugen | Visual Acuity (VA) | Visit 2, Week 0, first injection (N=812) | 8.72 lines of VA | Standard Deviation 5.19 |
| Macugen | Visual Acuity (VA) | Visit 3, Week 6 (N=785) | 8.67 lines of VA | Standard Deviation 4.9 |
| Macugen | Visual Acuity (VA) | Visit 4, Week 12 (N=684) | 8.93 lines of VA | Standard Deviation 4.97 |
| Macugen | Visual Acuity (VA) | Visit 5, Week 18 (N=537) | 9.06 lines of VA | Standard Deviation 4.81 |
| Macugen | Visual Acuity (VA) | Visit 6, Week 24 (N=253) | 8.83 lines of VA | Standard Deviation 5.32 |
| Macugen | Visual Acuity (VA) | Visit 7, Week 30 (N=203) | 8.60 lines of VA | Standard Deviation 4.69 |
| Macugen | Visual Acuity (VA) | Visit 8, Week 36 (N=133) | 8.07 lines of VA | Standard Deviation 3.81 |
| Macugen | Visual Acuity (VA) | Visit 9, Week 42 (N=86) | 8.35 lines of VA | Standard Deviation 3.42 |
| Macugen | Visual Acuity (VA) | Visit 10, Week 48 (N=54) | 8.33 lines of VA | Standard Deviation 3.44 |
| Macugen | Visual Acuity (VA) | Visit 11, Week 54 (N=11) | 8.86 lines of VA | Standard Deviation 3.3 |
| Macugen | Visual Acuity (VA) | Visit 12, Week 60 (N=6) | 9.34 lines of VA | Standard Deviation 3.33 |
| Macugen | Visual Acuity (VA) | Visit 13, Week 66 (N=4) | 8.49 lines of VA | Standard Deviation 3.01 |
| Macugen | Visual Acuity (VA) | Visit 14, Week 72 (N=2) | 7.61 lines of VA | Standard Deviation 3.37 |
| Macugen | Visual Acuity (VA) | Last Visit (N=786) | 9.26 lines of VA | Standard Deviation 5.24 |
Other Pre-specified
Change in IOP Between Predose and Postdose Assessment
IOP measured at each visit using either applanation tonometry or non-contact before and after intraviterial injection. Change in IOP equals postdose IOP minus predose IOP.
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Population: Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 2, Week 0 (N=559) | 1.3 mmHg | Standard Deviation 3.7 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 3, Week 6 (N=704) | 1.3 mmHg | Standard Deviation 4.1 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 4, Week 12 (N=600) | 1.3 mmHg | Standard Deviation 3.8 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 5, Week 18 (N=240) | 1.4 mmHg | Standard Deviation 3.7 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 6, Week 24 (N=210) | 1.5 mmHg | Standard Deviation 3.3 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 7, Week 30 (N=158) | 2.4 mmHg | Standard Deviation 4.9 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 8, Week 36 (N=90) | 1.8 mmHg | Standard Deviation 2.5 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 9, Week 42 (N=63) | 2.2 mmHg | Standard Deviation 2.8 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 10, Week 48 (N=48) | 2.3 mmHg | Standard Deviation 2.1 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 11, Week 54 (n=7) | 1.3 mmHg | Standard Deviation 1.7 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 12, Week 60 (N=4) | 1.3 mmHg | Standard Deviation 6.3 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Visit 13, Week 66 (N=2) | -2.0 mmHg | Standard Deviation 4.2 |
| Macugen | Change in IOP Between Predose and Postdose Assessment | Last Visit (N=718) | 1.4 mmHg | Standard Deviation 3.9 |
Other Pre-specified
Intraocular Pressure (IOP)
IOP measured at each visit using either applanation tonometry or non-contact before intraviterial injection, reported as pre-dose pressure of treated eye in millimeters of mercury (mmHg). The timeframe was as follows: Visit 1: IOP before any injection; Visit 2: IOP before first injection; Visit 3: IOP before second injection.
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Population: Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Macugen | Intraocular Pressure (IOP) | Visit 1, Baseline (N=809) | 15.7 mmHg | Standard Deviation 2.8 |
| Macugen | Intraocular Pressure (IOP) | Visit 2, Week 0 (N=568) | 15.7 mmHg | Standard Deviation 3 |
| Macugen | Intraocular Pressure (IOP) | Visit 3, Week 6 (N=772) | 15.7 mmHg | Standard Deviation 3.2 |
| Macugen | Intraocular Pressure (IOP) | Visit 4, Week 12 (N=661) | 15.8 mmHg | Standard Deviation 3.1 |
| Macugen | Intraocular Pressure (IOP) | Visit 5, Week 18 (N=505) | 15.9 mmHg | Standard Deviation 3.1 |
| Macugen | Intraocular Pressure (IOP) | Visit 6, Week 24 (N=237) | 15.5 mmHg | Standard Deviation 2.8 |
| Macugen | Intraocular Pressure (IOP) | Visit 7, Week 30 (N=190) | 15.5 mmHg | Standard Deviation 2.6 |
| Macugen | Intraocular Pressure (IOP) | Visit 8, Week 36 (N=123) | 15.8 mmHg | Standard Deviation 2.3 |
| Macugen | Intraocular Pressure (IOP) | Visit 9, Week 42 (N=80) | 15.4 mmHg | Standard Deviation 2 |
| Macugen | Intraocular Pressure (IOP) | Visit 10, Week 48 (N=53) | 15.7 mmHg | Standard Deviation 2.3 |
| Macugen | Intraocular Pressure (IOP) | Visit 11, Week 54 (N=11) | 16.3 mmHg | Standard Deviation 2.9 |
| Macugen | Intraocular Pressure (IOP) | Visit 12, Week 60 (N=6) | 15.3 mmHg | Standard Deviation 4 |
| Macugen | Intraocular Pressure (IOP) | Visit 13, Week 66 (N=4) | 18.0 mmHg | Standard Deviation 2.3 |
| Macugen | Intraocular Pressure (IOP) | Visit 14, Week 72 (N=2) | 17.0 mmHg | Standard Deviation 1.4 |
| Macugen | Intraocular Pressure (IOP) | Last Visit (N=776) | 15.6 mmHg | Standard Deviation 3 |
Other Pre-specified
IOP Mean Difference (Within a Participant)
Average predose minus postdose mean difference in IOP within a participant
Time frame: Baseline, every 6 weeks up to Month 24 or early termination
Population: Safety Set; N=number of participants with evaluable data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Macugen | IOP Mean Difference (Within a Participant) | 1.3 mmHg | Standard Deviation 2.9 |
Other Pre-specified
Number of Participants With Complications Associated With Injection
Complications associated with injection during the study with onset at or after date of first injection was recorded by the Investigator.
Time frame: Baseline up to Month 24 or early termination
Population: Safety Set; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Number of Participants With Complications Associated With Injection | Yes | 1 Participants |
| Macugen | Number of Participants With Complications Associated With Injection | No | 814 Participants |
Other Pre-specified
Time to First Adverse Event (AE)
Time to first AE during the study evaluated by Kaplan-Meier Product-limit methods. AE:any untoward medical occurrence in a participant administered a product or medical device in the context of study; the event need not necessarily have a causal relationship with the treatment or usage.
Time frame: Baseline up to Month 24 or early termination
Population: Safety Set: all participants who received at least 1 Macugen (pegaptanib) injection and provided data post baseline. Data not analyzed due to low number of AEs.
Other Pre-specified
Treatment Tolerability
Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor.
Time frame: Month 24 or early termination
Population: Safety Set; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Macugen | Treatment Tolerability | Moderate | 35 Participants |
| Macugen | Treatment Tolerability | Poor | 5 Participants |
| Macugen | Treatment Tolerability | Very Good | 182 Participants |
| Macugen | Treatment Tolerability | Good | 367 Participants |