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12 Week Patient Study in Neovascular Age-related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362348
Recruitment Status : Terminated (Lack of efficacy identified during a preliminary analysis)
First Posted : May 30, 2011
Results First Posted : August 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Macular Degeneration
Intervention Drug: pazopanib eye drops
Enrollment 19
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description Eligible participants instilled a single drop (approximately 40 micro liters ) of the pazopanib ophthalmic solution 10 milligram per millimeter (mg/mL) via topical ocular route to the study eye at approximate 5 hour intervals four times a day (QID) during the non-sleep period for a duration of 12 weeks.
Period Title: Overall Study
Started 19
Completed 5
Not Completed 14
Reason Not Completed
Protocol-defined stopping criteria             9
Study closed/terminated             5
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
76.3  (6.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
14
  73.7%
Male
5
  26.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
19
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Change From Baseline in Central Retinal Lesion Thickness (CRT) as Measured by Optical Coherence Tomography (OCT) at Day 29
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat (ITT) Population comprised of any participant who received at least one dose of study medication. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Microns
37.91  (89.692)
2.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Count of letters
0.07  (9.973)
3.Secondary Outcome
Title Change From Baseline in Central Retinal Lesion Thickness (CRLT) Over Time
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Microns
CRLT at Week 1 Number Analyzed 19 participants
-3.97  (93.420)
CRLT at Week 2 Number Analyzed 19 participants
-6.39  (93.420)
CRLT at Week 3 Number Analyzed 14 participants
15.15  (86.646)
CRLT at Week 4 Number Analyzed 13 participants
31.72  (88.289)
CRLT at Week 6 Number Analyzed 10 participants
51.22  (84.679)
CRLT at Week 8 Number Analyzed 8 participants
15.48  (82.304)
CRLT at Week 12 Number Analyzed 6 participants
-1.57  (75.216)
CRLT at Follow-up Number Analyzed 11 participants
-8.42  (91.346)
4.Secondary Outcome
Title Change From Baseline in Intraretinal (IR) or Subretinal (SR) Fluid Thickness, Intraretinal Cysts or Serous Retinal Pigment Epithelial Detachment (PED Thickness) Over Time
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Microns
SR fluid thickness at Week 1 Number Analyzed 17 participants
-34.79  (70.781)
SR fluid thickness at Week 2 Number Analyzed 18 participants
-29.32  (71.654)
SR fluid thickness at Week 3 Number Analyzed 13 participants
-0.22  (67.074)
SR fluid thickness at Week 4 Number Analyzed 12 participants
5.69  (67.938)
SR fluid thickness at Week 6 Number Analyzed 10 participants
28.05  (67.192)
SR fluid thickness at Week 8 Number Analyzed 7 participants
35.25  (64.689)
SR fluid thickness at Week 12 Number Analyzed 4 participants
1.72  (57.734)
SR fluid thickness at Follow-up Number Analyzed 8 participants
8.43  (70.329)
PED thickness at Week 1 Number Analyzed 12 participants
4.01  (56.669)
PED thickness at Week 2 Number Analyzed 12 participants
4.47  (56.669)
PED thickness at Week 3 Number Analyzed 9 participants
14.00  (53.040)
PED thickness at Week 4 Number Analyzed 9 participants
7.16  (54.843)
PED thickness at Week 6 Number Analyzed 5 participants
37.93  (49.035)
PED thickness at Week 8 Number Analyzed 3 participants
36.57  (46.786)
PED thickness at Week 12 Number Analyzed 3 participants
-32.68  (46.509)
PED thickness at Follow-up Number Analyzed 7 participants
-19.04  (56.214)
5.Secondary Outcome
Title Change From Baseline in BCVA Over Time
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were analyzed. OC dataset was used for analysis.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: Letters
Week 1 Number Analyzed 19 participants
0.26  (11.015)
Week 2 Number Analyzed 19 participants
0.26  (11.015)
Week 3 Number Analyzed 14 participants
-1.47  (9.927)
Week 4 Number Analyzed 13 participants
0.07  (9.973)
Week 6 Number Analyzed 10 participants
1.76  (9.345)
Week 8 Number Analyzed 8 participants
0.63  (8.912)
Week 12 Number Analyzed 6 participants
-0.85  (8.069)
Follow-up Number Analyzed 11 participants
-5.49  (10.388)
6.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: millimeter square
CNV Size at Week 4 1.38  (2.902)
CNV total lesion complex size at Week 4 1.37  (2.892)
7.Secondary Outcome
Title Number of Participants With Change in Charactertsics (Atrophy, Pigment, SR Hemorrhage, IR Hemorrhage, SR Fluid and Fibrosis) as Measured by FP
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants with data available at the indicated time point were analyzed. OC dataset was used for analysis.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 13
Measure Type: Count of Participants
Unit of Measure: Participants
Atrophy at Week 4
0
   0.0%
Pigment at Week 4
12
  92.3%
Heme (SR) at Week 4
10
  76.9%
Heme (IR) at Week 4
1
   7.7%
SR fluid at Week 4
13
 100.0%
Fibrosis at Week 4
1
   7.7%
8.Secondary Outcome
Title Number of Participants Who Received Rescue Medication
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population comprised of any participant who received at least one dose of study medication.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
9
  47.4%
9.Secondary Outcome
Title Number of Participants With Ocular Adverse Events (AEs), Non-ocular AEs, Serious Ocular AEs and Serious Non-ocular AEs
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Any Ocular AE
8
  42.1%
Any Ocular SAE
0
   0.0%
Any Non-Ocular AE
9
  47.4%
Any Non-Ocular SAE
0
   0.0%
10.Secondary Outcome
Title Number of Participants With Values of Potential Clinical Concern for Ocular Assessments on General Ophthalmic Examination
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11.Secondary Outcome
Title Number of Participants With Vital Sign Data of Potential Clinical Concern
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Systolic blood pressure
2
  10.5%
Diastolic blood pressure
0
   0.0%
Heart rate
0
   0.0%
12.Secondary Outcome
Title Number of Participants With Clinical Chemistry and Hematology Data of Potential Clinical Concern
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Glucose high
1
   5.3%
Carbon dioxide low
2
  10.5%
Lymphocyte low
1
   5.3%
Platelet count low
1
   5.3%
13.Secondary Outcome
Title Number of Participants With Abnormal Urinalysis Data by Urine Microscopy and Dipstick Analysis
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the specified time points were analyzed,
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Measure Type: Count of Participants
Unit of Measure: Participants
Red blood cells 3-5 at Week 2 Number Analyzed 1 participants
1
 100.0%
Red blood cells 0-1 at Week 4 Number Analyzed 3 participants
1
  33.3%
Red blood cells 1-3 at Week 4 Number Analyzed 3 participants
1
  33.3%
Red blood cells 25-50 at Week 4 Number Analyzed 3 participants
1
  33.3%
Red blood cells 1-3 at Follow-up Number Analyzed 5 participants
1
  20.0%
Red blood cells 5-10 at Follow-up Number Analyzed 5 participants
2
  40.0%
White blood cells 3-5 at Week 2 Number Analyzed 1 participants
1
 100.0%
White blood cells 1-3 at Week 4 Number Analyzed 3 participants
1
  33.3%
White blood cells 5-10 at Week 4 Number Analyzed 3 participants
1
  33.3%
White blood cells 10-15 at Follow-up Number Analyzed 5 participants
1
  20.0%
White blood cells 50-100 at Follow-up Number Analyzed 5 participants
1
  20.0%
Urine protein 2+ at Week 4 Number Analyzed 13 participants
1
   7.7%
Urine protein 1+ at Week 12 Number Analyzed 6 participants
1
  16.7%
Urine protein 2+ at Week 12 Number Analyzed 6 participants
1
  16.7%
Urine protein 1+ at Follow-up Number Analyzed 17 participants
1
   5.9%
Urine protein 3+ at Follow-up Number Analyzed 17 participants
1
   5.9%
14.Secondary Outcome
Title Summary of Plasma Pazonib Concentration
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population was defined as participants in the ITT Population for whom a pharmacokinetic sample was obtained and analyzed. Only those participants available at the specified time points were analyzed.
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description:
Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliter
Week 2 Number Analyzed 19 participants
279.0  (171.66)
Week 3 Number Analyzed 7 participants
323.9  (216.77)
Week 4 Number Analyzed 14 participants
360.5  (215.80)
Week 6 Number Analyzed 1 participants
498.0 [1]   (NA)
Week 8 Number Analyzed 1 participants
150.0 [1]   (NA)
Week 12 Number Analyzed 6 participants
255.3  (170.06)
[1]
Standard could was not computed as a single participant was analyzed.
Time Frame Up to Follow-up (Day 102)
Adverse Event Reporting Description Safety population was used for analysis.
 
Arm/Group Title Pazopanib 10 mg/mL QID
Hide Arm/Group Description Eligible participants instilled a single drop (approximately 40 microliters ) of the pazopanib ophthalmic solution 10 mg/mL via topical ocular route to the study eye at approximate 5 hour intervals QID during the non-sleep period for a duration of 12 weeks.
All-Cause Mortality
Pazopanib 10 mg/mL QID
Affected / at Risk (%)
Total   0/19 (0.00%) 
Hide Serious Adverse Events
Pazopanib 10 mg/mL QID
Affected / at Risk (%)
Total   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pazopanib 10 mg/mL QID
Affected / at Risk (%)
Total   17/19 (89.47%) 
Eye disorders   
Age-related macular degeneration  1  2/19 (10.53%) 
Macular oedema  1  1/19 (5.26%) 
Ocular Hypertension  1  1/19 (5.26%) 
Retinal haemorrhage  1  1/19 (5.26%) 
Vitreous floaters  1  1/19 (5.26%) 
Gastrointestinal disorders   
Nausea  1  1/19 (5.26%) 
Oesophageal obstruction  1  1/19 (5.26%) 
General disorders   
Instillation site pain  1  3/19 (15.79%) 
Infections and infestations   
Tooth infection  1  1/19 (5.26%) 
Urinary tract infection  1  1/19 (5.26%) 
Injury, poisoning and procedural complications   
Skeletal injury  1  1/19 (5.26%) 
Investigations   
Platelet count decreased  1  1/19 (5.26%) 
Protein urine present  1  1/19 (5.26%) 
Red blood cells urine positive  1  1/19 (5.26%) 
Urine protein/creatinine ratio increased  1  1/19 (5.26%) 
Musculoskeletal and connective tissue disorders   
Arthritis  1  1/19 (5.26%) 
Tendonitis  1  1/19 (5.26%) 
Torticollis  1  1/19 (5.26%) 
Psychiatric disorders   
Depression  1  1/19 (5.26%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/19 (5.26%) 
Dyshponia  1  1/19 (5.26%) 
Vascular disorders   
Hypertension  1  1/19 (5.26%) 
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01362348    
Other Study ID Numbers: 114987
First Submitted: May 19, 2011
First Posted: May 30, 2011
Results First Submitted: July 18, 2017
Results First Posted: August 21, 2017
Last Update Posted: September 21, 2017