| Primary | Mean Reduction (in Study Eye) in Rate of Growth of Geographic Atrophy (GA) at Day 309 | GA is the advanced form of dry age-related macular degeneration (AMD). The reduction in GA area of the study eye was based on Fundus Autofluorescence (FAF) at 30 days post last dose administration (Day 309). | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline and Day 309 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 | Placebo | Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses. |
| | | |
| Primary | Mean Reduction (in Study Eye) in Rate of Growth of GA at Day 449 (End of Study) | GA is the advanced form of dry AMD. The reduction in GA area in the study eye was based on FAF at end of study (Day 449). | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline and Day 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 | Placebo |
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| Secondary | Mean Best Corrected Visual Acuity (BCVA) at 9, 12, 15 Months and End of Study | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
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| Secondary | Percentage Change From Baseline in BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
|
| Secondary | Percentage Change From Baseline in BCVA Correct Number of Lines at Months 9, 12, 15 Months and End of Study | BCVA is measured using an eye chart and is reported as the number of lines read correctly in the study eye. The lower the number of lines read correctly on the eye chart, the worse the vision (or visual acuity). | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
|
| Secondary | Mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) at 9, 12, 15 Months and End of Study | LL-BCVA is the measure of visual acuity under low light conditions. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 | Placebo |
|
| Secondary | Percentage Change From Baseline in LL-BCVA Correct Number of Letters at 9, 12, 15 Months and End of Study | LL-BCVA is the measure of visual acuity under low light conditions. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 |
|
| Secondary | Percentage Change From Baseline in LL-BCVA Correct Number of Lines at 9, 12, 15 Months and End of Study | LL-BCVA is the measure of visual acuity under low light conditions. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 |
|
| Secondary | Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study | Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Participants were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
|
| Secondary | Percentage Change From Baseline in Contrast Sensitivity at 9, 12, 15 Months and End of Study | Contrast sensitivity was measured using the Pelli-Robson chart at 1 meter. Subjects were tested for contrast sensitivity using +0.50 addition over the protocol refraction providing the best-corrected distance VA. Contrast sensitivity was recorded as the log of the faintest triplet for which 2 of the 3 letters were read correctly. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
|
| Secondary | Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study | Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
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| Secondary | Change From Placebo in Reading Speed at 9, 12, 15 Months and End of Study | Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
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| Secondary | Percentage Change From Baseline in Reading Speed at 9, 12, 15 Months and End of Study | Reading speed in the study eye was assessed using modified Bailey-Lovie word charts. Participants read the chart for 2 minutes and the number of words read correctly per minute was totaled. An increase in the number of words read correctly indicated an improvement and a decrease in the number of words read correctly indicated a worsening. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | |
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| Secondary | Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study | Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD (logrithmic Reading Acuity Determination). | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 |
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| Secondary | Change From Placebo in Reading Acuity at 9, 12, 15 Months and End of Study | Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
| |
| Secondary | Percentage Change From Baseline in Reading Acuity at 9, 12, 15 Months and End of Study | Reading Acuity was measured using the Radner reading charts and expressed in terms of logRAD. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 |
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| Secondary | Change From Baseline in Critical Print Size Reading at 9, 12, 15 Months and End of Study | The critical print size is the smallest print size at which participants can read with their maximum reading speed. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 |
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| Secondary | Change From Placebo in Critical Print Size Reading at 9, 12, 15 Months and End of Study | The critical print size is the smallest print size at which participants can read with their maximum reading speed. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Month 9, Month 12, Month 15, and End of Study | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
| |
| Secondary | Number of Participants With Treatment-Emergent Laboratory Abnormalities | Laboratory assessments include: hematology (hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen, creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid albumin, total protein); coagulation assessments. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Day 85 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg |
|
| Secondary | Number of Participants With Abnormal Change From Baseline in Vital Signs | Vital sign assessments include: supine systolic and diastolic blood pressure, pulse rate and body temperature. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Screening, Days 28, 57, 85, 113, 141, and 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 |
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| Secondary | Number of Participants With Clinically Significant Treatment-Emergent Electrocardiogram (ECG) Findings | Clinically significant ECG findings include: corrected QT (QTc) > 450 msec, QTc >500 msec, change in QTc between 30 and 60 msec, change in QTc greater than or equal to 60 msec. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Days 28, 57, 85, 113 and 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | |
|
| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) | The number of participants with positive ADA was to be summarized for each treatment arm. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Day 57 and Day 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 | Placebo |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) According to Seriousness | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | The safety analysis set included all participants who received at least 1 dose of study drug. | Posted | | Number | | Participants | | Days 28, 57, 85, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
|
| Secondary | Number of Participants With Treatment-Related TEAEs | An AE was an untoward medical occurrence in a participant who received study drug without regard to causal relationship. An investigator's relationship assessment is the determination of whether there exists a reasonable possibility that the investigational product caused or contributed to an AE. | The safety analysis set included all participants who received at least one dose of study product. | Posted | | Number | | Participants | | Days 28, 57, 85, 113, 141 and 169 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 | Placebo |
|
| Secondary | Maximum Observed Plasma Concentration (Cmax) | | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
| |
| Secondary | Minimum Observed Plasma Trough Concentration (Cmin) | | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
| |
| Secondary | Area Under the Concentration-Time Curve From Time Zero Until Last Sampling Time (AUCt) | | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
| |
| Secondary | Clearance at Steady State (CLss) | Steady state total body clearance equals infusion rate (zero order) divided by steady state plasma concentration of study drug (R0/Css) | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
| |
| Secondary | Accumulation Ratio (Rac) for AUCt | | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Days 1, 28,57, 85, 169, 253, 281, 309, 337, and 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
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| Secondary | Plasma Population PK Parameters | Population PK parameters were to be evaluated for Cmax, AUCt, Cmin, CLss, and Rac for AUCt between the first and last (11th) doses. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. |
| |
| Secondary | Change From Baseline in Total Amyloid Beta (A-Beta) 1-x Plasma Concentration at End of Study (Day 449) | Concentration of total amino acid peptide, known as A-Beta 1-x, in plasma. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Day 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 | Placebo |
|
| Secondary | Change From Baseline in Amyloid Beta (A-Beta) 1-40 Plasma Concentration at End of Study (Day 449) | Concentration of amino acid peptide, known as A-Beta 1-40, in plasma. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Day 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 | Placebo |
|
| Secondary | Change From Baseline in Amyloid Beta (A-Beta) 1-42 Plasma Concentration at End of Study (Day 449) | Concentration of amino acid peptide, known as A-Beta 1-42, in plasma. | Analysis was not performed due to early study termination. As only 10 participants enrolled at the time of termination, there were not enough subjects or data to perform meaningful analyses (8 were assigned to active drug [1 was not dosed and there was notable variability on how many doses were received by the other 7]; 2 were assigned to placebo). | Posted | | | | | | Baseline, Day 449 | | | | ID | Title | Description |
|---|
| OG000 | PF-04382923 2.5 mg/kg | PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses. | | OG001 | PF-04382923 7.5 mg/kg | PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG002 | PF-04382923 15.0 mg/kg | PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses. | | OG003 | Placebo |
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