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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.
Ophthalmologists who are experienced in doing intravitreal injections in Germany
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Macugen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegaptanib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline, every 6 weeks up to Month 24 or early termination |
| 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. | Baseline, every 6 months up to Month 24 or early termination |
| 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. | Month 24 or early termination |
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to Month 24 or early termination |
Inclusion Criteria:
Exclusion Criteria:
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Patients with neovascular age-related macular degeneration
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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This observational study did not define endpoints as primary or secondary. All endpoints arbitrarily assigned as primary for reporting results.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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. | Posted | Mean | Standard Deviation | lines of VA | Baseline, every 6 weeks up to Month 24 or early termination |
|
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The Safety population (N=816) is less than total number of participants in study (1001) because some participants had a baseline visit but no injection or no data post baseline. The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endophthalmitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | MedDRA | Non-systematic Assessment |
Time to first AE not estimated due to insufficient number of events. Visit numbers for NEI-VFQ-25 deviated from numbering used in other analyses; it represents the sequence number of questionaries administered (Visit 1=first assessment, etc.).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C495058 | pegaptanib |
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|
| Baseline, every 6 weeks up to Month 24 or early termination |
| 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. | Week 6 |
| 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. | Week 12 |
| 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. | Week 18 |
| 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. | Week 24 |
| 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. | Week 30 |
| 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. | Week 36 |
| 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. | Week 42 |
| 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. | Week 48 |
| 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. | Week 54 |
| 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. | Week 60 |
| 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. | Week 66 |
| 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. | Week 72 |
| 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. | Month 24 or early termination |
| 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. | Baseline |
| 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. | Week 6 |
| 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. | Week 12 |
| 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. | Week 18 |
| 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. | Week 24 |
| 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. | Week 30 |
| 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. | Week 36 |
| 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. | Week 42 |
| 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. | Week 48 |
| 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. | Week 54 |
| 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. | Month 24 or early termination |
| 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). | Baseline, every 6 weeks up to Month 24 or early termination |
| 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). | Baseline |
| 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). | Week 6 |
| 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). | Week 12 |
| 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). | Week 18 |
| 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). | Week 24 |
| 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). | Week 30 |
| 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). | Week 36 |
| 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). | Week 42 |
| 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). | Week 48 |
| 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). | Week 54 |
| 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. | Month 24 or early termination |
| 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. | Baseline up to Month 24 or early termination |
| Treatment Tolerability | Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor. | Month 24 or early termination |
| 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. | Baseline, every 6 weeks up to Month 24 or early termination |
| 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. | Baseline, every 6 weeks up to Month 24 or early termination |
| IOP Mean Difference (Within a Participant) | Average predose minus postdose mean difference in IOP within a participant | Baseline, every 6 weeks up to Month 24 or early termination |
| Death |
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| Other |
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| Missing discontinuation status |
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| years |
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| Sex/Gender, Customized | Number | participants |
|
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. |
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| 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. | FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline, every 6 months up to Month 24 or early termination |
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| 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. | FAS; N = number of participants with evaluable data. | Posted | Number | Participants | Month 24 or early termination |
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| 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). | FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value. | Posted | Mean | Standard Deviation | number of optic disc areas | Baseline, every 6 weeks up to Month 24 or early termination |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 6 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 12 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 18 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 24 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 30 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 36 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 42 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 48 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 54 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 60 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 66 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 72 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Month 24 or early termination |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Baseline |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 6 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 12 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 18 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 24 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 30 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 36 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 42 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 48 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 54 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Month 24 or early termination |
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| 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). | FAS; N=number of participants with evaluable data; Last Visit: last available postbaseline value. | Posted | Mean | Standard Deviation | Micrometers (Mcm) | Baseline, every 6 weeks up to Month 24 or early termination |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Baseline |
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| 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). | FAS;N=number of participants with evaluable data. | Posted | Number | Participants | Week 6 |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 12 |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 18 |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 24 |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 30 |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 36 |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 42 |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 48 |
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| 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). | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Week 54 |
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| 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. | FAS; N=number of participants with evaluable data. | Posted | Number | Participants | Month 24 or early termination |
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| 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. | 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. | Posted | Median | 95% Confidence Interval | Days | Baseline up to Month 24 or early termination |
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| 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. | Safety Set; N=number of participants with evaluable data. | Posted | Number | Participants | Baseline up to Month 24 or early termination |
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| Other Pre-specified | Treatment Tolerability | Investigator's overall evaluation of tolerability; Categories included: Very Good, Good, Moderate, and Poor. | Safety Set; N=number of participants with evaluable data. | Posted | Number | Participants | Month 24 or early termination |
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| 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. | Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value. | Posted | Mean | Standard Deviation | mmHg | Baseline, every 6 weeks up to Month 24 or early termination |
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| 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. | Safety Set; N=number of participants with evaluable data; Last Visit: last available postbaseline value. | Posted | Mean | Standard Deviation | mmHg | Baseline, every 6 weeks up to Month 24 or early termination |
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| Other Pre-specified | IOP Mean Difference (Within a Participant) | Average predose minus postdose mean difference in IOP within a participant | Safety Set; N=number of participants with evaluable data. | Posted | Mean | Standard Deviation | mmHg | Baseline, every 6 weeks up to Month 24 or early termination |
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| 16 |
| 816 |
| 12 |
| 816 |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA | Non-systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
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| Choroidal neovascularisation | Eye disorders | MedDRA | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA | Non-systematic Assessment |
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| Retinal tear | Eye disorders | MedDRA | Non-systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
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| Choroidal neovascularisation | Eye disorders | MedDRA | Non-systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA | Non-systematic Assessment |
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| Detachment of retinal pigment epithelium | Eye disorders | MedDRA | Non-systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA | Non-systematic Assessment |
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| Subretinal fibrosis | Eye disorders | MedDRA | Non-systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA | Non-systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA | Non-systematic Assessment |
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| Paracentesis eye | Investigations | MedDRA | Non-systematic Assessment |
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| Injection site reaction | General disorders | MedDRA | Non-systematic Assessment |
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| Eye operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Measurements |
|---|---|
|
| Visit 4, Month 18 (N=135) |
|
| Visit 5, Month 24 (N=338) |
|
| Last Visit (N=410) |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Title | Measurements |
|---|---|
|
| Visit 5, Week 18 (N=316) |
|
| Visit 6, Week 24 (N=45) |
|
| Visit 7, Week 30 (N=45) |
|
| Visit 8, Week 36 (N=78) |
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| Visit 9, Week 42 (N=15) |
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| Visit 10, Week 48 (N=9) |
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| Visit 11, Week 54 (N=6) |
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| Visit 12, Week 60 (N=2) |
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| Visit 13, Week 66 (N=3) |
|
| Last Visit (N=513) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Visit 5, Week 18 (N=205) |
|
| Visit 6, Week 24 (N=33) |
|
| Visit 7, Week 30 (N=26) |
|
| Visit 8, Week 36 (N=27) |
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| Visit 9, Week 42 (N=13) |
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| Visit 10, Week 48 (N=3) |
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| Last Visit (N=311) |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|---|
|
| predominantly classic |
|
| pure classic |
|
| Title | Measurements |
|---|
|
| Poor |
|
| Title | Measurements |
|---|---|
|
| Visit 4, Week 12 (N=661) |
|
| Visit 5, Week 18 (N=505) |
|
| Visit 6, Week 24 (N=237) |
|
| Visit 7, Week 30 (N=190) |
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| Visit 8, Week 36 (N=123) |
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| Visit 9, Week 42 (N=80) |
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| Visit 10, Week 48 (N=53) |
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| Visit 11, Week 54 (N=11) |
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| Visit 12, Week 60 (N=6) |
|
| Visit 13, Week 66 (N=4) |
|
| Visit 14, Week 72 (N=2) |
|
| Last Visit (N=776) |
|
| Title | Measurements |
|---|---|
|
| Visit 5, Week 18 (N=240) |
|
| Visit 6, Week 24 (N=210) |
|
| Visit 7, Week 30 (N=158) |
|
| Visit 8, Week 36 (N=90) |
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| Visit 9, Week 42 (N=63) |
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| Visit 10, Week 48 (N=48) |
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| Visit 11, Week 54 (n=7) |
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| Visit 12, Week 60 (N=4) |
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| Visit 13, Week 66 (N=2) |
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| Last Visit (N=718) |
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