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This study will examine the safety and efficacy of pegaptanib sodium in Japanese patients with wet-type age-related macular degeneration (AMD), who benefit further treatment and who want to continue the treatment after completion of the preceding study (A5751010).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EYE001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegaptanib sodium | Drug | 1 drop per dosed eye per protocol. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Adverse Events | Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events | Week 54 (initiation of A5751015 study) up to Week 198 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Nagoya | Aichi-ken | Japan | |||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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All subjects received a 0.3 mg or 1 mg/eye EYE001 (pegaptanib sodium) intravitreal injection every 6 weeks for 48 weeks in the preceding study A5751010 (NCT00150202)
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| ID | Title | Description |
|---|---|---|
| FG000 | EYE001 | All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EYE001 | All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Change in Visual Acuity From Baseline of A5751010 (NCT00150202) to Each Observation Time Point | Change: value at each observation time point minus value at baseline of A5751010 (NCT00150202). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0. | Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat. Last Observation Carried Forward | Posted | Mean | Standard Deviation | letters | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
|
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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 | EYE001 | All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular degeneration | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival hemorrhage | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trails.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@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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| Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
| Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Value at each observation time point minus value at Week 54 (initiation of current study). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0. | Weeks 54, every 18 weeks from Week 54 up to Week 198 |
| Number of Responders | Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain. | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
| Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
| Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline. | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
| Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity. | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
| Urayasu |
| Chiba |
| Japan |
| Pfizer Investigational Site | Fukuoka | Fukuoka | Japan |
| Pfizer Investigational Site | Fukushima | Fukushima | Japan |
| Pfizer Investigational Site | Maebashi | Gunma | Japan |
| Pfizer Investigational Site | Sapporo | Hokkaido | Japan |
| Pfizer Investigational Site | Kyoto | Kyoto | Japan |
| Pfizer Investigational Site | Moriguchi | Osaka | Japan |
| Pfizer Investigational Site | Suita | Osaka | Japan |
| Pfizer Investigational Site | ÅŒtsu | Shiga | Japan |
| Pfizer Investigational Site | Chiyoda-ku | Tokyo | Japan |
| Pfizer Investigational Site | Shinjuku-ku | Tokyo | Japan |
| Withdrawal by Subject |
|
| participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Mean Change in Visual Acuity From the Starting Point of Current Study to Each Observation Time Point | Value at each observation time point minus value at Week 54 (initiation of current study). Visual acuity was measured as number of letters that the participants for this study could read in Early Treatment Diabetic Retinopathy Study (ETDRS) chart (eyesight-test chart).The best value in visual acuity using ETDRS chart is 85 and the worst value in visual acuity is 0. | Intent-to-treat, Among 61 subjects, for efficacy analyses, 1 subject had missing data at Week 72. Last Observation Carried Forward | Posted | Mean | Standard Deviation | letters | Weeks 54, every 18 weeks from Week 54 up to Week 198 |
|
|
|
| Secondary | Number of Responders | Responders defined as subjects having lost from baseline of A5751010 (NCT00150202) less than 15 letters of visual acuity; includes subjects with visual acuity gain. | Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 were excluded from Intent-to-treat. Last Observation Carried Forward | Posted | Number | participants | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
|
|
|
| Secondary | Number of Subjects Gaining Vision From Baseline of A5751010 (NCT00150202) | Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. | Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat. Last Observation Carried Forward | Posted | Number | participants | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
|
|
|
| Secondary | Number of Subjects Who Are Maintaining Vision From Baseline of A5751010 (NCT 00150202) | Maintaining vision includes gaining 0 letter or more in visual acuity using Early Treatment Diabetic Retinopathy Study chart from baseline. | Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT 00150202) were excluded from Intent-to-treat. Last Observation Carried Forward | Posted | Number | participants | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
|
|
|
| Secondary | Number of Subjects With Severe Vision Loss From Baseline of A5751010 (NCT 00150202) | Subjects with severe vision loss: loss from baseline of >= 30 letters of visual acuity. | Among Intent-to-treat, 8 subjects who entered the current study 14 days or more after the completion of Study A5751010 (NCT00150202) were excluded from Intent-to-treat. Last Observation Carried Forward | Posted | Number | participants | Week 0 (baseline), every 18 weeks from Week 54 up to Week 198 |
|
|
|
| Primary | Summary of Adverse Events | Number of subjects with serious and non-serious adverse events: Subjects with ophthalmic adverse events: Subjects with severe adverse events that interferes significantly with subject's usual function: Subjects discontinued due to adverse events: Subjects with dose reduction or temporary discontinuation due to adverse events | Intent-to-treat | Posted | Number | participants | Week 54 (initiation of A5751015 study) up to Week 198 |
|
|
|
| 16 |
| 61 |
| 43 |
| 61 |
| Angina pectoris | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA (11.1) | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Gastric polyps | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (11.1) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.1) | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.1) | Systematic Assessment |
|
| Cataract traumatic | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (11.1) | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Large intestine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (11.1) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (11.1) | Systematic Assessment |
|
| Aortic aneurysm | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Arteriosclerosis obliterans | Vascular disorders | MedDRA (11.1) | Systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA 11.0). | Non-systematic Assessment |
|
| Corneal erosion | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Keratitis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Myodesopsia | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Punctate keratitis | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Retinal haemorrhage | Eye disorders | MedDRA 11.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of < 60 days.Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites.Investigator may not disclose previously undisclosed confidential info other than study results.
| Title | Measurements |
|---|---|
|
| Week 126 |
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| Week 144 |
|
| Week 162 |
|
| Week 180 |
|
| Week 198 |
|
| Title | Measurements |
|---|
|
| Week 108 |
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| Week 126 |
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| Week 144 |
|
| Week 162 |
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| Week 180 |
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| Week 198 |
|
| Title | Measurements |
|---|
|
| Week 108 |
|
| Week 126 |
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| Week 144 |
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| Week 162 |
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| Week 180 |
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| Week 198 |
|
| Title | Measurements |
|---|
|
| Week 108 |
|
| Week 126 |
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| Week 144 |
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| Week 162 |
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| Week 180 |
|
| Week 198 |
|
| Title | Measurements |
|---|
|
| Week 108 |
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| Week 126 |
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| Week 144 |
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| Week 162 |
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| Week 180 |
|
| Week 198 |
|
| Title | Measurements |
|---|---|
|
| Subjects with severe adverse events |
|
| Severe Myocardial Infarction |
|
| Severe Femur Fracture |
|
| Severe Gastric Cancer |
|
| Severe Pancreatic Carcinoma |
|
| Subjects discontinued due to adverse events |
|
| Subjects with dose reduction or temporary disconti |
|