A Phase 2 interventional study of pazopanib eye drops in Macular Degeneration, sponsored by GlaxoSmithKline. Terminated at 15 sites in 3 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-09-21.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
The purpose of this 12 week, open-label study is to investigate the safety and efficacy of a single dose regimen of pazopanib eye drop for neovascular AMD.
MD7114987 is a Phase 2a study designed to determine whether pazopanib eye drops have the potential to reduce retinal edema and maintain or improve visual acuity in persons with a previously untreated subfoveal choroidal neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) and to further characterize the safety and tolerability of pazopanib eye drops administered over a 12-week period.
1,473 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 19 is below the median of 51 across 984 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
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Subjects eligible for enrolment in the study must meet all of the following criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria must not be enrolled in the study:
Study Eye:
Fellow Eye:
Concurrent Conditions or Concomitant Medications:
Systolic blood pressure > 160 mmHg Diastolic blood pressure > 100 mmHg Note: Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided the referenced criteria are met (See Section 4.4.3).
pazopanib topical ocular administration
Drug: pazopanib eye drops
10 mg/mL (1 drop) four times daily
Change From Baseline in Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29
CRT was the distance between the inner limiting membrane of the retina and the inner border of the retinal pigment epithelium/choriocapillaris band, inclusive of sub retinal fluid, measured in the central 1 millimeter (mm) of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Images were evaluated by investigator for safety monitoring, and by a central reading center for eligibility determination and pharmacodynamics (PD) effects. Observed case (OC) data set was used for analysis in this analysis dataset, a missing assessment at any scheduled time point was considered unevaluable, was not imputed and was not included in data analysis. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the baseline value from the individual post-randomization value at Day 29.
Time frame: Baseline (Week 0) and Day 29
Change From Baseline in Best Correct Visual Acuity (BCVA) as Measured by the Number of Letters Determined by Electronic Early Treatment Diabetic Retinopathy [ETDRS] Study Visual Acuity (EVA) at Day 29
BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
Time frame: Baseline (Day -3 to -1) and Day 29
Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time
CRLT was the manual measurement of the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris, inclusive of subretinal or sub-retinal pigment epithelium fluid collections and of the thickness of any observable choroidal neovascular membrane or scar tissue, evaluated in the central 1 mm of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
Time frame: Baseline (Week -3 to -1) Up to Follow-up (Day 102)
Change From Baseline in Intraretinal (IR) or Subretinal (SR) Fluid Thickness, Intraretinal Cysts or Serous Retinal Pigment Epithelial Detachment (PED Thickness) Over Time
OCT was used for the determination of retinal morphology changes in the study eye which included assessments of SR fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and PED (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
Time frame: Baseline (Week -3 to -1) Up to Follow-up (Day 102)
Change From Baseline in BCVA Over Time
BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
Time frame: Baseline (Week -3 to -1) Up to Follow-up (Day 102)
Change From Baseline in the Area of Choroidal Neovascular (CNV) Size and CNV Total Lesion Complex Size as Measured by Fluorescein Angiography (FA) at Day 29
CNV was the measurement of the combined classic and occult neovascular lesion including areas of classic neovascularization, late staining of undetermined origin and fibrovascular PED. CNV total lesion complex size was the measurement of the entire lesion including classic and occult neovascular components as well as contagious blood and/or blocked fluorescence and/or serous PED. FA uses fundus photography (FP) to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling/circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. A fluorescein angiogram was obtained at Day 29. Images were evaluated by investigator for eligibility and by a central reading center for determination of PD effect. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
Time frame: Baseline (Day -3 to -1) and Day 29
Number of Participants With Change in Charactertsics (Atrophy, Pigment, SR Hemorrhage, IR Hemorrhage, SR Fluid and Fibrosis) as Measured by FP
Fundus photography involves capturing of images of the center of the very back inner wall of the eye - the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme SR hemorrhage (absence or presence at the location), heme IR hemorrhage (absence or presence at the location), SR fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment (absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29.
Time frame: Day 29
Number of Participants Who Received Rescue Medication
At any time during the study, including the follow-up period, rescue treatment (standard of care) was given based on the clinical judgment of the investigator. Rescue treatment was to be strongly considered for participants whose center subfield thickness had increased by \>50 microns from the lowest value on study or whose BCVA decreased by more than 5 letters compared to baseline and who also had persistent fluid by OCT. Data has been reported for the number of participants with their percentages who required any rescue medication administration until follow-up.
Time frame: Up to follow-up (Day 102)
Number of Participants With Ocular Adverse Events (AEs), Non-ocular AEs, Serious Ocular AEs and Serious Non-ocular AEs
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.
Time frame: Until Follow-up (Day 102)
Number of Participants With Values of Potential Clinical Concern for Ocular Assessments on General Ophthalmic Examination
A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), Intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 102.
Time frame: Up to Follow-up (Day 102)
Number of Participants With Vital Sign Data of Potential Clinical Concern
Vital sign assessments included systolic blood pressure, diastolic blood pressure and heart rate. The potential clinical concern range for systolic blood pressure was \<85 and \>160 millimeters of mercury, diastolic blood pressure \<45 and \> 100 millimeters of mercury, heart rate \<40 and \>110 beats per minute. Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for systolic blood pressure, diastolic blood pressure and heart rate until Day 102.
Time frame: Up to Follow-up (Day 102)
Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern
Clinical chemistry parameters included albumin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, direct bilirubin, total bilirubin, calcium, chloride, carbon dioxide, creatinine, thyroxine (T3 free), gamma glutamyl transferase, glucose, potassium, sodium, total protein, total T3, urea, uric acid while hematology included basophils, eosinophils, hemoglobin, hematocrit, lymphocytes, mean corpuscle hemoglobin concentration, mean corpuscle hemoglobin, mean corpuscle volume, monocytes, segmented neutrophils, total neutrophils, platelet count, red blood cell count, reticulocytes and white blood cell count. The potential clinical concern ranges were as follows: glucose-low \<3 and high \>9 millimoles per liter (mmol/L), carbon dioxide-low \<18 and high \>34 mmol/L, lymphocyte-low \<0.8 giga per liter (G/L) and platelet count was \<100 and high \>550 G/L. Data has been presented for the number of participants with values high and low of potential clinical concern.
Time frame: Up to Follow-up (Day 102)
Number of Participants With Abnormal Urinalysis Data by Urine Microscopy and Dipstick Analysis
Urinalysis measurements included assessments for red blood cells and white blood cells via microscopic examination while assessments for urine protein by standard dipstick analysis. Data has been presented for the number of participants with abnormal urinalysis results.
Time frame: Up to Follow-up (Day 102)
Summary of Plasma Pazonib Concentration
Throughout the study, 1 to 4 blood samples (2 mL) were collected from each participants for the analysis of plasma pazopanib concentrations between 0.55 to 10.83 hours post-dose on Weeks 2, 3, 4, 6 (unplanned), 8 (unplanned) and 12. The concentrations from the three blood samples per participant were averaged and then the values were averaged through all the participants. Blood samples were collected without restriction for the time interval between blood draw and the last dose of pazopanib eye drops.
Time frame: Up to Week 12
This study was conducted at 10 sites in the United States, Germany and France from 7 July 2011 was early terminated on 22 Mar 2012 and completed on 16 April 2012. The study was terminated due to lack of efficacy.
| Milestone | Pazopanib 10 mg/mL QID |
|---|---|
| Started | 19 |
| Completed | 5 |
| Not completed | 14 |
| Withdrew: Protocol-defined stopping criteria | 9 |
| Withdrew: Study closed/terminated | 5 |
CRT was the distance between the inner limiting membrane of the retina and the inner border of the retinal pigment epithelium/choriocapillaris band, inclusive of sub retinal fluid, measured in the central 1 millimeter (mm) of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Images were evaluated by investigator for safety monitoring, and by a central reading center for eligibility determination and pharmacodynamics (PD) effects. Observed case (OC) data set was used for analysis in this analysis dataset, a missing assessment at any scheduled time point was considered unevaluable, was not imputed and was not included in data analysis. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the baseline value from the individual post-randomization value at Day 29.
| Microns | Pazopanib 10 mg/mL QID |
|---|---|
| Change From Baseline in Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29 | 37.91 ± 89.692 |
BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
| Count of letters | Pazopanib 10 mg/mL QID |
|---|---|
| Change From Baseline in Best Correct Visual Acuity (BCVA) as Measured by the Number of Letters Determined by Electronic Early Treatment Diabetic Retinopathy [ETDRS] Study Visual Acuity (EVA) at Day 29 | 0.07 ± 9.973 |
CRLT was the manual measurement of the distance between the inner limiting membrane of the retina and the inner border of the choriocapillaris, inclusive of subretinal or sub-retinal pigment epithelium fluid collections and of the thickness of any observable choroidal neovascular membrane or scar tissue, evaluated in the central 1 mm of the Cube scan. OCT assessments were performed using SPECTRALIS spectral domain OCT. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
| Microns | Pazopanib 10 mg/mL QID |
|---|---|
| CRLT at Week 1 | -3.97 ± 93.420 |
| CRLT at Week 2 | -6.39 ± 93.420 |
| CRLT at Week 3 | 15.15 ± 86.646 |
| CRLT at Week 4 | 31.72 ± 88.289 |
| CRLT at Week 6 | 51.22 ± 84.679 |
| CRLT at Week 8 | 15.48 ± 82.304 |
| CRLT at Week 12 | -1.57 ± 75.216 |
| CRLT at Follow-up | -8.42 ± 91.346 |
OCT was used for the determination of retinal morphology changes in the study eye which included assessments of SR fluid (an exudate between the retina and choroid from various sources including the vitreous cavity, subarachnoid space, or abnormal vessels) and PED (retinal pigment epithelium separates from the underlying Bruch's membrane due to the presence of blood, serous exudate, drusen, or a neovascular membrane). Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
| Microns | Pazopanib 10 mg/mL QID |
|---|---|
| SR fluid thickness at Week 1 | -34.79 ± 70.781 |
| SR fluid thickness at Week 2 | -29.32 ± 71.654 |
| SR fluid thickness at Week 3 | -0.22 ± 67.074 |
| SR fluid thickness at Week 4 | 5.69 ± 67.938 |
| SR fluid thickness at Week 6 | 28.05 ± 67.192 |
| SR fluid thickness at Week 8 | 35.25 ± 64.689 |
| SR fluid thickness at Week 12 | 1.72 ± 57.734 |
| SR fluid thickness at Follow-up | 8.43 ± 70.329 |
| PED thickness at Week 1 | 4.01 ± 56.669 |
| PED thickness at Week 2 | 4.47 ± 56.669 |
| PED thickness at Week 3 | 14.00 ± 53.040 |
| PED thickness at Week 4 | 7.16 ± 54.843 |
| PED thickness at Week 6 | 37.93 ± 49.035 |
| PED thickness at Week 8 | 36.57 ± 46.786 |
| PED thickness at Week 12 | -32.68 ± 46.509 |
| PED thickness at Follow-up | -19.04 ± 56.214 |
BCVA was measured in the study eye using the EVA chart starting at a test distance of 4 meters. The BCVA score is the number of letters read correctly by the participant. A decrease in the BCVA score indicates a worsening of vision while higher scores indicates improvement of VA. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
| Letters | Pazopanib 10 mg/mL QID |
|---|---|
| Week 1 | 0.26 ± 11.015 |
| Week 2 | 0.26 ± 11.015 |
| Week 3 | -1.47 ± 9.927 |
| Week 4 | 0.07 ± 9.973 |
| Week 6 | 1.76 ± 9.345 |
| Week 8 | 0.63 ± 8.912 |
| Week 12 | -0.85 ± 8.069 |
| Follow-up | -5.49 ± 10.388 |
CNV was the measurement of the combined classic and occult neovascular lesion including areas of classic neovascularization, late staining of undetermined origin and fibrovascular PED. CNV total lesion complex size was the measurement of the entire lesion including classic and occult neovascular components as well as contagious blood and/or blocked fluorescence and/or serous PED. FA uses fundus photography (FP) to capture images of injected dye circulating throughout the retinal blood vessels to assess leaking, swelling/circulation problems caused by various eye diseases like diabetic retinopathy and wet macular degeneration. A fluorescein angiogram was obtained at Day 29. Images were evaluated by investigator for eligibility and by a central reading center for determination of PD effect. Baseline was defined as the assessments performed between Day -3 to -1. Change from Baseline was calculated by subtracting the Baseline value from the individual post-randomization value at Day 29.
| millimeter square | Pazopanib 10 mg/mL QID |
|---|---|
| CNV Size at Week 4 | 1.38 ± 2.902 |
| CNV total lesion complex size at Week 4 | 1.37 ± 2.892 |
Fundus photography involves capturing of images of the center of the very back inner wall of the eye - the retina, optic nerve, macula and main retinal blood vessels. The parameters assessment were heme SR hemorrhage (absence or presence at the location), heme IR hemorrhage (absence or presence at the location), SR fluid (absence or presence at location), fibrosis (absence or presence at location), atrophy (absence or presence of atrophic changes) and pigment (absence or presence at location). A protocol set of fundus photographs were obtained at Day 29. Images were read by the investigator for eligibility determination, and by a central reading center for determination of PD effect. Data has been presented for number of participants with changes in eye characteristics in the study eye at Day 29.
| Participants | Pazopanib 10 mg/mL QID |
|---|---|
| Atrophy at Week 4 | 0 |
| Pigment at Week 4 | 12 |
| Heme (SR) at Week 4 | 10 |
| Heme (IR) at Week 4 | 1 |
| SR fluid at Week 4 | 13 |
| Fibrosis at Week 4 | 1 |
At any time during the study, including the follow-up period, rescue treatment (standard of care) was given based on the clinical judgment of the investigator. Rescue treatment was to be strongly considered for participants whose center subfield thickness had increased by \>50 microns from the lowest value on study or whose BCVA decreased by more than 5 letters compared to baseline and who also had persistent fluid by OCT. Data has been reported for the number of participants with their percentages who required any rescue medication administration until follow-up.
| Participants | Pazopanib 10 mg/mL QID |
|---|---|
| Number of Participants Who Received Rescue Medication | 9 |
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury.
| Participants | Pazopanib 10 mg/mL QID |
|---|---|
| Any Ocular AE | 8 |
| Any Ocular SAE | 0 |
| Any Non-Ocular AE | 9 |
| Any Non-Ocular SAE | 0 |
A complete eye examination was performed to include the following: Examination of eyelids and lashes (including meibomian glands), Pupil, motility and confrontation visual field examination, Slit lamp evaluation of anterior ocular structures (including conjunctiva, tear film, cornea with fluorescein staining, anterior chamber, iris, lens, and anterior vitreous), Intraocular pressure (IOP) measurement and Dilated Fundus Examination (Indirect ophthalmoscopy and slit lamp biomicroscopy). Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for complete ophthalmic examinations until Day 102.
| Participants | Pazopanib 10 mg/mL QID |
|---|---|
| Number of Participants With Values of Potential Clinical Concern for Ocular Assessments on General Ophthalmic Examination | 0 |
Vital sign assessments included systolic blood pressure, diastolic blood pressure and heart rate. The potential clinical concern range for systolic blood pressure was \<85 and \>160 millimeters of mercury, diastolic blood pressure \<45 and \> 100 millimeters of mercury, heart rate \<40 and \>110 beats per minute. Data has been presented in a consolidated format for the total number of participants with values of potential clinical concern for systolic blood pressure, diastolic blood pressure and heart rate until Day 102.
| Participants | Pazopanib 10 mg/mL QID |
|---|---|
| Systolic blood pressure | 2 |
| Diastolic blood pressure | 0 |
| Heart rate | 0 |
Clinical chemistry parameters included albumin, alkaline phosphatase, alanine amino transferase, aspartate amino transferase, direct bilirubin, total bilirubin, calcium, chloride, carbon dioxide, creatinine, thyroxine (T3 free), gamma glutamyl transferase, glucose, potassium, sodium, total protein, total T3, urea, uric acid while hematology included basophils, eosinophils, hemoglobin, hematocrit, lymphocytes, mean corpuscle hemoglobin concentration, mean corpuscle hemoglobin, mean corpuscle volume, monocytes, segmented neutrophils, total neutrophils, platelet count, red blood cell count, reticulocytes and white blood cell count. The potential clinical concern ranges were as follows: glucose-low \<3 and high \>9 millimoles per liter (mmol/L), carbon dioxide-low \<18 and high \>34 mmol/L, lymphocyte-low \<0.8 giga per liter (G/L) and platelet count was \<100 and high \>550 G/L. Data has been presented for the number of participants with values high and low of potential clinical concern.
| Participants | Pazopanib 10 mg/mL QID |
|---|---|
| Glucose high | 1 |
| Carbon dioxide low | 2 |
| Lymphocyte low | 1 |
| Platelet count low | 1 |
Urinalysis measurements included assessments for red blood cells and white blood cells via microscopic examination while assessments for urine protein by standard dipstick analysis. Data has been presented for the number of participants with abnormal urinalysis results.
| Participants | Pazopanib 10 mg/mL QID |
|---|---|
| Red blood cells 3-5 at Week 2 | 1 |
| Red blood cells 0-1 at Week 4 | 1 |
| Red blood cells 1-3 at Week 4 | 1 |
| Red blood cells 25-50 at Week 4 | 1 |
| Red blood cells 1-3 at Follow-up | 1 |
| Red blood cells 5-10 at Follow-up | 2 |
| White blood cells 3-5 at Week 2 | 1 |
| White blood cells 1-3 at Week 4 | 1 |
| White blood cells 5-10 at Week 4 | 1 |
| White blood cells 10-15 at Follow-up | 1 |
| White blood cells 50-100 at Follow-up | 1 |
| Urine protein 2+ at Week 4 | 1 |
| Urine protein 1+ at Week 12 | 1 |
| Urine protein 2+ at Week 12 | 1 |
| Urine protein 1+ at Follow-up | 1 |
| Urine protein 3+ at Follow-up | 1 |
Throughout the study, 1 to 4 blood samples (2 mL) were collected from each participants for the analysis of plasma pazopanib concentrations between 0.55 to 10.83 hours post-dose on Weeks 2, 3, 4, 6 (unplanned), 8 (unplanned) and 12. The concentrations from the three blood samples per participant were averaged and then the values were averaged through all the participants. Blood samples were collected without restriction for the time interval between blood draw and the last dose of pazopanib eye drops.
| nanograms per milliliter | Pazopanib 10 mg/mL QID |
|---|---|
| Week 2 | 279.0 ± 171.66 |
| Week 3 | 323.9 ± 216.77 |
| Week 4 | 360.5 ± 215.80 |
| Week 6 | 498.0 ± NA |
| Week 8 | 150.0 ± NA |
| Week 12 | 255.3 ± 170.06 |
Collected over Up to Follow-up (Day 102). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pazopanib 10 mg/mL QID | 0/19 (0%) | 0/19 (0%) | 17/19 (89.5%) |
| Event | Pazopanib 10 mg/mL QID |
|---|---|
| Instillation site painGeneral disorders | 3/19 |
| Age-related macular degenerationEye disorders | 2/19 |
| Macular oedemaEye disorders | 1/19 |
| Ocular HypertensionEye disorders | 1/19 |
| Retinal haemorrhageEye disorders | 1/19 |
| Vitreous floatersEye disorders | 1/19 |
| NauseaGastrointestinal disorders | 1/19 |
| Oesophageal obstructionGastrointestinal disorders | 1/19 |
| Tooth infectionInfections and infestations | 1/19 |
| Urinary tract infectionInfections and infestations | 1/19 |
| Age, Continuous(Years) | Pazopanib 10 mg/mL QID |
|---|---|
| Mean | 76.3 ± 6.65 |
| Sex: Female, Male(Participants) | Pazopanib 10 mg/mL QID |
|---|---|
| Female | 14 |
| Male | 5 |
| Race (NIH/OMB)(Participants) | Pazopanib 10 mg/mL QID |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
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