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| Name | Class |
|---|---|
| ITEC GROUP 3 | UNKNOWN |
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To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart), of a 0.3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks in patients with exudative age-related macular degeneration and evidence of recent onset, subfoveal and/or juxtafoveal choroidal neovascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pegaptanib sodium (Macugen) | Drug | 0.3 MG/eye pegaptanib IB sodium by intravitreous injection given every 6 weeks for 54 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) | Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain. | Baseline, 54 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Acuity | Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline. |
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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 | Angers | Cedex 09 | 49933 | France | ||
| 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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| ID | Title | Description |
|---|---|---|
| FG000 | Pegaptanib Sodium | All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Baseline, 6 weeks, 12 weeks, 54 weeks |
| Number of Subjects Gaining Vision | Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. | 54 weeks or at early termination |
| Number of Subjects Maintaining Vision | Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. | 54 weeks or at early termination |
| Number of Subjects With Severe Visual Loss | Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. | 54 weeks or at early termination |
| Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) | Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54. Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54. | 54 weeks |
| Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; 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, 54 weeks or at early termination |
| Lyon |
| Cedex 4 |
| 69317 |
| France |
| Pfizer Investigational Site | Besançon | Cedex | 25030 | France |
| Pfizer Investigational Site | Créteil | Cedex | 94010 | France |
| Pfizer Investigational Site | Mâcon | Cedex | 71018 | France |
| Pfizer Investigational Site | Poitiers | Cedex | 86021 | France |
| Pfizer Investigational Site | Bayonne | 64100 | France |
| Pfizer Investigational Site | Belfort | 90016 | France |
| Pfizer Investigational Site | Bordeaux | 33076 | France |
| Pfizer Investigational Site | Bordeaux | 33100 | France |
| Pfizer Investigational Site | Brest | 29200 | France |
| Pfizer Investigational Site | Dijon | 21033 | France |
| Pfizer Investigational Site | La Rochefoucauld | 16110 | France |
| Pfizer Investigational Site | La Tronche | 38700 | France |
| Pfizer Investigational Site | Lille | 59800 | France |
| Pfizer Investigational Site | Limoges | 87042 | France |
| Pfizer Investigational Site | Lyon | 69003 | France |
| Pfizer Investigational Site | Marseille | 13008 | France |
| Pfizer Investigational Site | Montpellier | 34000 | France |
| Pfizer Investigational Site | Montpellier | 34070 | France |
| Pfizer Investigational Site | Mulhouse | 68070 | France |
| Pfizer Investigational Site | Nancy | 54000 | France |
| Pfizer Investigational Site | Nantes | 44093 | France |
| Pfizer Investigational Site | Paris | 75006 | France |
| Pfizer Investigational Site | Paris | 75015 | France |
| Pfizer Investigational Site | Paris | 75557 | France |
| Pfizer Investigational Site | Paris | 75940 | France |
| Pfizer Investigational Site | Rives | 38140 | France |
| Pfizer Investigational Site | Rouen | 76000 | France |
| Pfizer Investigational Site | Saint-Herblain | 44819 | France |
| Pfizer Investigational Site | Strasbourg | 67000 | France |
| Pfizer Investigational Site | Strasbourg | 67091 | France |
| Pfizer Investigational Site | Toulouse | 31054 | France |
| Pfizer Investigational Site | Toulouse | 31200 | France |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pegaptanib Sodium | All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Number of Responders for Visual Acuity Using Early Treatment Diabetic Retinopathy Study (ETDRS) | Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Responders defined as subjects having lost from baseline less than 15 letters of the best-corrected visual acuity; includes subjects with visual acuity gain. | The full analysis set (FAS) was derived from the set of all enrolled subjects who 1) were administered the study medication AND 2) had post-baseline documentation of efficacy available. In the case of missing data post-baseline, the subject was considered censored at the time of the last available data for the score. | Posted | Number | participants | Baseline, 54 Weeks |
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| Secondary | Change From Baseline in Visual Acuity | Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. Change: mean score at observation minus mean score at baseline. | FAS; n=number of subjects with evaluable data. | Posted | Mean | Standard Deviation | score on scale | Baseline, 6 weeks, 12 weeks, 54 weeks |
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| Secondary | Number of Subjects Gaining Vision | Subjects gaining vision: gain from baseline of more than 15 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. | FAS | Posted | Number | participant | 54 weeks or at early termination |
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| Secondary | Number of Subjects Maintaining Vision | Subjects maintaining vision: gain from baseline of more than 0 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. | FAS | Posted | Number | participants | 54 weeks or at early termination |
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| Secondary | Number of Subjects With Severe Visual Loss | Subjects with severe visual loss: loss from baseline of >= 30 letters of visual acuity. Best-corrected visual acuity assessed using retroilluminated modified Ferris-Bailey ETDRS charts. When possible to measure visual acuity @ 2.0 m (≥20 letters), visual acuity score for that eye recorded as number of letters correct plus 15; otherwise, score was number of letters read correctly @ 1.0 m plus number, if any, read @ 2.0 m. If no letter was read correctly either at 2.0 or 1.0 m, then visual acuity score was recorded as 0. | FAS | Posted | Number | participants | 54 weeks or at early termination |
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| Secondary | Number of Subjects With a Distance Visual Acuity of > 20/200 at Baseline and Progressing to (<= 20/200) | Subjects with improving scores are those with > 20/200 at Baseline and progressing to =< 20/200 at Week 54. Subjects with no change are those with > 20/200 at Baseline and remaining at > 20/200 at Week 54. | FAS; n=77 (number of Subjects at Baseline with >20/200 Visual Acuity) | Posted | Number | participants | 54 weeks |
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| Secondary | Change in Vision-related Functioning and Quality of Life Using the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ 25). | Patient reported vision-related functioning and quality of life as measured using the 25 item NEI-VFQ 25. Change = Mean score at 54 weeks - mean score at baseline. A positive change represents an increase in function/health from Baseline. Items grouped as the following - Composite: mean score items 1-25; 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 subjects with evaluable data. | Posted | Mean | Standard Deviation | score on scale | Baseline, 54 weeks or at early termination |
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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 | Pegaptanib Sodium | All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks. | 8 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (v12.0) | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA (v12.0) | Systematic Assessment |
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| Cataract operation | Eye disorders | MedDRA (v12.0) | Systematic Assessment |
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| Macular degeneration | Eye disorders | MedDRA (v12.0) | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA (v12.0) | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA (v12.0) | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA (v12.0) | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA (v12.0) | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA (v12.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (v12.0) | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA (v12.0) | Systematic Assessment |
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| Macular degeneration | Eye disorders | MedDRA (v12.0) | Systematic Assessment |
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| Myodesopsia | Eye disorders | MedDRA (v12.0) | Systematic Assessment |
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| Pain | General disorders | MedDRA (v12.0) | Systematic Assessment |
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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 information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.govCallCenter@pfizer.com |
| 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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