An Extension to Study MD7108240

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00733304
• Collaborator: (none)
• Enrollment: 42
• Locations: 17
• Arms: 3
• Actual Duration (Months): 14.5
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: Pazopanib	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: An Extension Study to Protocol MD7108240: Pazopanib Eye Drops in Subjects With Neovascular Age-related Macular Degeneration
• Actual Study Start Date: Jun 25, 2008
• Actual Primary Completion Date: Sep 9, 2009
• Actual Study Completion Date: Sep 9, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 5 mg/ml TID eligible participants received 5 mg/ml Pazopanib eye drops three times daily (TID)	Drug: Pazopanib; 5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
Experimental: 2 mg/ml TID eligible participants received 2 mg/ml Pazopanib eye drops three times daily	Drug: Pazopanib; 5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
Experimental: 5 mg/ml QD eligible participants received 5 mg/ml Pazopanib eye drops once daily (QD)	Drug: Pazopanib; 5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD

Outcome Measures

Primary Outcome Measures

1. Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period [Baseline (Day 1) and approximately up to 6 months]

   Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. SBP and DBP were recorded from Baseline up to 6 months. At screening and Baseline, if the single measured value of blood pressure was above 150 millimeters of mercury (mm Hg) systolic or 95 mm Hg diastolic, then blood pressure measurement could not be repeated. If, the SBP was <80 or >140 mm Hg and DBP was <40 or >90 mm Hg, then measurement of BP was repeated. Three consecutive blood pressure readings that were less than 150 mmHg systolic and 95 mmHg diastolic were taken with each measurement separated by at least 1 hour.

2. Change From Baseline (Day 1) in Heart Rate Over Period [Baseline (Day 1) and approximately up to 6 months]

   Heart rate was measured over 6 months. Baseline value was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Heart rate measurement were repeated in case it was in range < 50 beats per minute (bpm) or >110 bpm.

3. Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period [Baseline (Day 1), Month 2, 5 and approximately up to Month 6]

   Albumin and hemoglobin values were recorded at Baseline, Month2, and till follow-up (Month 6). Baseline was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.

4. Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period [Baseline (Day 1) and approximately up to 6 months]

   ALP, ALT and AST values were measured over 5 months and till the follow-up period. Baseline value was recorded pre-dose Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.

5. Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period [Baseline (Day 1) and approximately up to 6 months]

   Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. The above mentioned hematological parameters were recorded from Baseline up to 5 months.

6. Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period [Baseline (Day 1) and approximately up to 6 months]

   Change from Baseline is the value at indicated time point minus the Baseline value. Over here, the change is % Basophils at month x - % Basophils at Baseline. Baseline measurement was recorded at Day 1. Percentage change in the hematological parameter mentioned above was recorded from Baseline up to 5 months.

7. Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period [Baseline (Day 1) and approximately up to 6 months]

   Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Direct bilirubin, total bilirubin, and creatinine were recorded from Baseline up to 6 months

8. Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period [Baseline (Day 1) and approximately up to 6 months]

   Change from Baseline (Day 1) is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Calcium, chloride, carbon di oxide equivalent content (CO2), glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) was recorded from Baseline up to Follow-up.

9. Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period [Baseline (Day 1) and approximately up to 6 months]

   Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. MCV was recorded from Baseline up to Follow-up.

10. Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period [Baseline (Day 1) and approximately up to 6 months]

    Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Intra-ocular pressure was recorded from Baseline up to Follow-up.

11. Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis [Approximately up to 6 months (up to follow-up)]

    In this dipstick test, the level of blood occult and glucose, ketones, protein in urine samples were recorded as negative, trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive).

12. Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs) [Approximately up to 6 months]

    Number of participants with ocular and non-ocular AEs and SAEs were separately recorded. An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.

13. Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI) [Approximately up to 6 months]

    Visual acuity was measured over 5 months and also during follow-up period. Visual acuity was measured using standardized early treatment of diabetic retinopathy study (ETDRS) visual acuity charts. Visual acuity measurement was performed by an examiner that had been appropriately trained. Screening, Month 2 and Month 5 data were considered as Best Corrected Visual Acuity (BCVA) data. A loss of greater than or equal to 15 letters in BCVA from Baseline was considered of PCI. Data for number of participants who met the criteria for PCI have been presented.

14. Number of Participants With Abnormal Pupil Examination of PCI [Up to follow-up (approximately 6 months)]

    Pupil abnormalities were of different types. Meibomian gland dysfunction was measured as obvious inspissation (debris). Mild injection, no trichiasis (lid thickening), or two step worsening was analyzed. Afferent pupillary defect, motility examination, PERRL, confrontation visual field was measured as a new definite abnormality. Left and right both eyes were examined.

15. Number of Participants With Abnormal Conjunctival Examination of PCI [Up to follow-up (approximately 6 months)]

    A two step worsening in the conjunctival examination was considered a value of PCI. Participants were analyzed for conjunctival examination up to follow-up (6 months).

16. Number of Participants With Abnormal Anterior Chamber Examination of PCI [Approximately up to 6 months]

    A two step worsening in the anterior chamber examination was considered a value of PCI. The participants were examined for any anterior chamber abnormality. Fibrinous response and obvious aqueous haze were considered abnormalities related to anterior chamber examination.

17. Number of Participants With Abnormal Corneal Examination of PCI [Approximately up to 6 months]

    A two step change in any of the lens opacity categories was categorized as of PCI. Corneal epithelium was defined as abnormal when punctate keratopathy was measured as mild, moderate, severe; epithelial edema was measured as subtle epithelial haze, mild patchy microcystic changes, diffuse microcystic changes, and/or investigator determined abnormality. Stromal opacity/ edema was measured by investigator when stroma identifies opacity or edema. Corneal staining was measured as obvious (<=20) localized or diffuse punctate staining areas, severe localized or diffuse punctate staining. Participants were analyzed for any of the mentioned abnormality over 6 weeks (up to follow-up period).

18. Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale [Approximately up to 6 months]

    A two step change in any of the lens opacity categories was considered a value of PCI. Aphakia (surgical removal of lens) or pseudophakia was noted if any. Stroma opacity or edema was measured by investigator when it was detected as edema or opacity in stroma.

19. Number of Participants With Abnormal Tear Films of PCI [Approximately up to 6 months]

    Tear film abnormalities were based on the clinical judgment of investigator. Tear film thickness was analyzed and it was reported whether the film was increased or decreased or was normal. Presence of debris or mucus was also reported. Other test were tear lake analysis and checking of discharge from eyes.

20. Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function [Approximately up to 6 months]

    Meibomian gland dysfunction was measured as obvious insipisation/debris, mild injection, no trichiasis or lid thickening; inspisation, debris, obvious injection, lid thickening, may have trsichiasis; or a two step worsening. Any 2+ worsening of Meibomian gland function was considered a value of PCI.

21. Number of Participants With Abnormal (Dilated) Fundus Examination [Approximately up to 6 months]

    Dilation of fundus was examined post dosing up to 6 months. Number of participants with abnormal change from Baseline indicating dilation of fundus of eye was reported. Change from Baseline was the value at indicated time point minus the Baseline value. The abnormalities were posterior vitreous separation, pale optic nerve, fluid in the posterior pole, drusen, thick arterio-venous changes, pigment changes, cystoids, macular edema, drying of posterior fluid or sub-retinal fluid, underlying central atrophy, and retinal pigment epithelial changes etc. Refraction measurement were determined at the screening and 2 month/5 month visits in order to determine BCVA.

Secondary Outcome Measures

1. Change From Baseline (Screening Visit) in BCVA at Month 2 and 5 [From Baseline (screening visit), Month 2, and Month 5]

   Change from Baseline in BCVA is the value at indicated time point minus the Baseline value. BCVA at screening visit was used as statistical Baseline. Only data before post-dose intravitreal injection of Avastin/ Lucentis (IVT) has been presented. Arithmetic mean was presented as data values; however statistical analysis is based on means of observed case (OC) data. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.

2. Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months [From Baseline (Screening visit) and up to 5 months]

   The OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of Pazopanib. The anatomic effects of pazopanib treatment were limited to investigator determined assessment of OCT central subfield retinal thickness due to heterogeneity of participant population and the low likelihood of utility of central reading center determination. The OCT equipment used was approved by central OTC reading center. OCT scans were collected at indicated time points and were evaluated by Investigator. Thus, grading of further secondary objectives was not performed as per the study team. Change from Baseline is the value at indicated time point minus the Baseline value. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.

3. Change in Neo-vascular Size and Lesion Size Over Period [Up to 6 weeks]

   The analysis was planned to be performed up to 6 months; however, due to heterogeneity of the population and the low likelihood of the utility of the data, the anatomic effects of the pazopanib treatment in this treatment were limited to investigator determined assessment of OCT central subfield retinal thickness. Thus, the study team decided not to have DARC (central reading center) perform the grading for the secondary PD outcomes like lesion size and change with respect to time were not analyzed. Thus, data was not collected for this outcome measure.

4. Number of Participants With Lesion Types Over Period [Up to 6 months]

   Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subjects who participated in Phase IIa study MD7108240 and who did not experience AMD disease progression requiring rescue therapy during pazopanib treatment or require discontinuation of pazopanib eye drops for safety reasons

• Best-corrected ETDRS visual acuity in the study eye of 23 letters (20/320 or 4/63) or better at screening.

• QTcB or QTcF < 450msec; or QTc < 480msec in subjects with Bundle Branch Block.

• Subject is willing and able to return for all study visits, and is willing and able to comply with all protocol requirements and procedures.

• Subject is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. If the subject is unable to read the consent form due to visual impairment then the consent must be read to the subject verbatim by person administering the consent, a family member or legally acceptable representative. If the subject is unable to provide written informed consent due to visual impairment, then written informed consent on behalf of the subject must be provided by a legally acceptable representative. (Note: Consent by legally acceptable representative is allowed where this is in accordance with local laws, regulations and ethics committee policy.)

Exclusion Criteria:

• Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation of the fundus for photographs, fluorescein angiography and OCT.

• Vitreous, subretinal or retinal hemorrhage in the study eye that is unrelated to AMD.

• Intraocular surgery in the study eye within 3 months of dosing.

• Use of topical ocular medications (other than pazopanib) in the study eye within 7 days of first dose of investigational product or expected use of topical ocular medications during the treatment period, with the exception of artificial tears.

• Current use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol).

• An unwillingness to refrain from wearing contact lenses starting from the screening visit, through the follow-up visit

• ALT or AST above the upper limit of normal or total bilirubin ≥ 1.5 times the upper limit of normal at baseline. Note: Laboratory tests outside of the normal range may be repeated at the discretion of the Investigator.

• Medical history or condition:

• Uncontrolled Diabetes Mellitus, with hemoglobin A1c (HbA1c) > 10%.

• Myocardial infarction or stroke within 6 months of screening.

• Active bleeding disorder.

• Major surgery within 1 month of screening.

• Hepatic impairment.

• Uncontrolled hypertension, based on criteria provided in the protocol. Note: Initiation or adjustment of antihypertensive medications is permitted prior to study entry provided the referenced criteria are met.

• Use of prohibited medications listed in the protocol within the restricted timeframe relative to the first dose of study medication.

• A condition or situation which, in the opinion of the investigator, may result in significant risk to the subject, confound the study results or interfere significantly with participation.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Beverly Hills	California	United States	90211
2	GSK Investigational Site	Sacramento	California	United States	95841
3	GSK Investigational Site	Winter Haven	Florida	United States	33880
4	GSK Investigational Site	Indianapolis	Indiana	United States	46280
5	GSK Investigational Site	Boston	Massachusetts	United States	02111
6	GSK Investigational Site	Ann Arbor	Michigan	United States	48105
7	GSK Investigational Site	Grand Rapids	Michigan	United States	49525
8	GSK Investigational Site	Salt Lake City	Utah	United States	84132
9	GSK Investigational Site	Sydney	New South Wales	Australia	2145
10	GSK Investigational Site	Sydney	New South Wales	Australia	2150
11	GSK Investigational Site	Melbourne	Victoria	Australia
12	GSK Investigational Site	Perth	Western Australia	Australia	6009
13	GSK Investigational Site	Milano	Lombardia	Italy	20132
14	GSK Investigational Site	Milano	Lombardia	Italy	20157
15	GSK Investigational Site	Torino	Piemonte	Italy	10122
16	GSK Investigational Site	Firenze	Toscana	Italy	50134
17	GSK Investigational Site	Padova	Veneto	Italy	35128

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00733304
• Other Study ID Numbers: MD7111396
• First Posted: Aug 13, 2008
• Last Update Posted: Dec 5, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by GlaxoSmithKline: age-related macular degeneration (AMD); choroidal neovascularization (CNV); vascular endothelial growth factor (VEGF); pazopanib; angiogenesis
• Additional relevant MeSH terms: Macular Degeneration

Study Results

Participant Flow

Recruitment Details	This was an extension study to protocol MD7108240 (NCT00612456). It was a multi-center, double-masked, randomized, parallel-group dose-ranging study of repeat topical ocular doses of pazopanib from 25 June 2008 to 9 September 2009. The study was conducted in 14 centers in the United States, Italy, and Australia.
Pre-assignment Detail	Randomized participants without progression of age-related macular degeneration (AMD) and/or requiring rescue therapy during the 28-day treatment period in study MD7108240 (NCT00612456) were included in this study. A total of 42 participants were randomized in the study.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 milligram/milliliter (mg/mL) Pazopanib eye drops three times daily for a treatment period of five months.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
Period Title: Overall Study
STARTED	19	15	8
COMPLETED	12	12	3
NOT COMPLETED	7	3	5

Baseline Characteristics

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD	Total
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.	Total of all reporting groups
Overall Participants	19	15	8	42
Age, Customized (Count of Participants)
55 to 88 aged	19 100%	15 100%	8 100%	42 100%
Sex: Female, Male (Count of Participants)
Female	15 78.9%	7 46.7%	5 62.5%	27 64.3%
Male	4 21.1%	8 53.3%	3 37.5%	15 35.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	19 100%	15 100%	8 100%	42 100%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period
Description	Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. SBP and DBP were recorded from Baseline up to 6 months. At screening and Baseline, if the single measured value of blood pressure was above 150 millimeters of mercury (mm Hg) systolic or 95 mm Hg diastolic, then blood pressure measurement could not be repeated. If, the SBP was <80 or >140 mm Hg and DBP was <40 or >90 mm Hg, then measurement of BP was repeated. Three consecutive blood pressure readings that were less than 150 mmHg systolic and 95 mmHg diastolic were taken with each measurement separated by at least 1 hour.
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population included all participants who received at least one dose of the study drug. Only those participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
DBP, Month 1	3.5 (9.05)	-0.4 (8.40)	1.1 (3.98)
DBP, Month 2	1.8 (8.79)	1.6 (8.32)	-0.5 (7.09)
DBP, Month 3	3.9 (8.03)	-0.9 (8.16)	1.5 (7.42)
DBP, Month 4	0.0 (8.49)	-0.4 (6.09)	0.0 (6.12)
DBP, Month 5	8.6 (11.83)	1.8 (7.40)	4.7 (19.73)
DBP, Follow-up	3.3 (9.04)	1.8 (9.59)	-2.8 (11.11)
SBP, Month 1	-2.4 (10.55)	0.5 (12.68)	-2.3 (9.22)
SBP, Month 2	-0.4 (14.91)	-3.0 (15.37)	-4.0 (7.91)
SBP, Month 3	-0.5 (16.29)	1.8 (12.46)	0.8 (10.63)
SBP, Month 4	-4.1 (10.37)	-1.9 (6.98)	-1.0 (8.83)
SBP, Month 5	0.0 (17.16)	-1.3 (14.71)	-9.7 (1.15)
SBP, Follow-up	0.6 (12.65)	0.9 (13.44)	-2.3 (5.99)

2. Primary Outcome

Title	Change From Baseline (Day 1) in Heart Rate Over Period
Description	Heart rate was measured over 6 months. Baseline value was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value. Heart rate measurement were repeated in case it was in range < 50 beats per minute (bpm) or >110 bpm.
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only the participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Month 1	-0.6 (9.81)	2.4 (9.19)	5.1 (9.82)
Month 2	-0.3 (8.50)	1.3 (8.89)	5.0 (9.52)
Month 3	1.4 (10.92)	-2.5 (13.90)	1.3 (7.37)
Month 4	-2.0 (9.80)	0.7 (9.85)	-2.2 (8.90)
Month 5	-0.8 (7.70)	0.6 (10.90)	9.3 (20.03)
Follow-up	-0.2 (6.78)	-1.8 (8.07)	5.0 (11.22)

3. Primary Outcome

Title	Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Description	Albumin and hemoglobin values were recorded at Baseline, Month2, and till follow-up (Month 6). Baseline was recorded on Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.
Time Frame	Baseline (Day 1), Month 2, 5 and approximately up to Month 6

Outcome Measure Data

Analysis Population Description

Safety population. Only the participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Albumin, Month 2	0.6 (1.46)	-0.7 (1.38)	-1.1 (1.96)
Albumin, Month 5	0.3 (2.15)	-1.0 (1.34)	-3.0 (1.00)
Albumin, Follow-up	-0.4 (1.67)	-1.1 (1.45)	0.2 (1.30)
Hemoglobin, Month 2	2.1 (6.95)	-0.5 (4.22)	-1.3 (8.35)
Hemoglobin, Month 5	-0.2 (10.04)	0.3 (5.05)	-6.0 (0.00)
Hemoglobin, Follow-up	-0.2 (8.65)	0.4 (8.66)	2.5 (5.26)

4. Primary Outcome

Title	Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period
Description	ALP, ALT and AST values were measured over 5 months and till the follow-up period. Baseline value was recorded pre-dose Day 1. Change from Baseline is the value at indicated time point minus the Baseline value.
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only the participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
ALP, Month 1	-2.8 (8.01)	-0.6 (11.24)	-0.1 (5.94)
ALP, Month 2	1.1 (7.73)	1.8 (6.03)	-2.3 (8.31)
ALP, Month 3	1.2 (8.19)	1.3 (8.94)	-7.5 (5.92)
ALP, Month 4	2.6 (10.58)	-3.5 (8.64)	-1.8 (6.91)
ALP, Month 5	0.7 (10.82)	-1.6 (8.99)	8.3 (13.80)
ALP, Follow-up	3.7 (13.77)	0.1 (7.98)	3.6 (4.62)
ALT, Month 1	2.1 (3.80)	-0.1 (1.90)	-0.4 (3.93)
ALT, Month 2	3.0 (3.41)	2.0 (4.12)	2.1 (4.94)
ALT, Month 3	0.9 (5.54)	-0.7 (3.39)	-0.8 (3.59)
ALT, Month 4	2.1 (5.07)	-1.3 (4.55)	-0.4 (2.30)
ALT, Month 5	2.3 (3.23)	-2.2 (6.82)	-1.0 (3.00)
ALT, Follow-up	2.2 (4.07)	-1.1 (3.21)	-0.2 (2.17)
AST, Month 1	1.7 (3.16)	0.0 (3.94)	-0.5 (3.78)
AST, Month 2	2.4 (3.42)	1.6 (3.93)	1.0 (2.93)
AST, Month 3	1.1 (3.94)	-1.0 (5.56)	0.0 (2.16)
AST, Month 4	0.1 (3.18)	0.0 (3.74)	1.2 (2.39)
AST, Month 5	1.8 (3.16)	-1.4 (5.33)	0.3 (2.89)
AST, Follow-up	2.0 (3.18)	-1.1 (3.78)	1.2 (4.15)

5. Primary Outcome

Title	Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period
Description	Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. The above mentioned hematological parameters were recorded from Baseline up to 5 months.
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only the participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Basophils, Month 2	0.008 (0.0246)	0.008 (0.0157)	-0.003 (0.0271)
Basophils, Month 5	0.007 (0.0237)	0.006 (0.0168)	-0.010 (0.0141)
Bsophils, Follow-up	0.010 (0.0234)	-0.003 (0.0142)	0.00 (0.00)
Eosinophils, Month 2	-0.043 (0.1604)	0.010 (0.1204)	-0.088 (0.1784)
Eosinophils, Month 5	0.034 (0.0952)	-0.009 (0.1324)	0.030 (0.1131)
Eosinophils,Follow-up	0.046 (0.1623)	0.007 (0.1083)	0.032 (0.0613)
Lymphocytes, Month 2	0.077 (0.8534)	0.051 (0.4203)	-0.031 (0.3855)
Lymphocytes, Month 5	-0.004 (0.5848)	0.068 (0.2245)	0.130 (0.3536)
Lymphocytes, Follow-up	-0.058 (0.4984)	0.090 (0.3412)	0.062 (0.1959)
Monocytes, Month 2	0.025 (0.1304)	0.025 (0.1621)	0.020 (0.1812)
Monocytes, Month 5	0.006 (0.2047)	0.036 (0.1272)	-0.015 (0.1202)
Monocytes, Follow-up	-0.035 (0.1506)	0.002 (0.1293)	0.030 (0.0942)
Platelets, Month 2	-1.1 (21.84)	1.3 (21.39)	11.9 (29.30)
Platelets, Month 5	1.3 (33.83)	-10.9 (15.48)	70.0 (62.23)
Platelets, Follow-up	-3.3 (22.50)	-7.3 (19.31)	8.3 (7.50)
White blood cells, Month 2	-0.42 (1.986)	-0.02 (1.027)	0.26 (1.334)
White blood cells, Month 5	-1.41 (2.938)	-0.00 (1.484)	0.50 (1.697)
White blood cells, Follow-up	-0.89 (2.614)	0.76 (2.558)	-0.07 (2.251)

6. Primary Outcome

Title	Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period
Description	Change from Baseline is the value at indicated time point minus the Baseline value. Over here, the change is % Basophils at month x - % Basophils at Baseline. Baseline measurement was recorded at Day 1. Percentage change in the hematological parameter mentioned above was recorded from Baseline up to 5 months.
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only the participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
% Basophils, Month 2	0.12 (0.340)	0.12 (0.251)	-0.05 (0.293)
% Basophils, Month 5	0.11 (0.274)	0.08 (0.226)	-0.20 (0.173)
% Basophils, Follow-up	0.17 (0.320)	-0.01 (0.193)	-0.04 (0.182)
% Eosinophils, Month 2	-0.44 (2.352)	0.19 (1.366)	-1.08 (2.089)
% Eosinophils, Month 5	0.60 (1.564)	0.16 (1.879)	-0.30 (0.964)
% Eosinophils,Follow-up	0.64 (2.601)	0.04 (1.828)	-0.56 (4.245)
% lymphocytes, Month 2	2.29 (11.781)	-0.52 (7.788)	-0.96 (4.260)
% lymphocytes, Month 5	4.42 (9.734)	0.83 (4.759)	3.87 (8.051)
% lymphocytes, Follow-up	2.29 (7.790)	-0.62 (4.021)	-3.66 (17.637)
% monocytes, Month 2	0.57 (1.671)	0.50 (1.974)	-0.19 (1.277)
% monocytes, Month 5	1.24 (3.029)	0.59 (1.358)	-0.67 (0.611)
% monocytes, Follow-up	0.06 (1.803)	-0.32 (1.236)	0.96 (3.247)
%Total neutrophils, Month 2	-2.54 (12.125)	-0.28 (7.709)	2.27 (3.593)
%Total neutrophils, Month 5	-6.36 (12.291)	-1.65 (6.020)	-2.70 (7.826)
%Total neutrophils, Follow-up	-3.16 (9.812)	0.90 (5.801)	3.30 (24.091)

7. Primary Outcome

Title	Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period
Description	Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Direct bilirubin, total bilirubin, and creatinine were recorded from Baseline up to 6 months
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Direct bilirubin, Month 1	-0.1 (0.47)	-0.2 (0.58)	0.3 (0.71)
Direct bilirubin, Month 2	0.2 (0.92)	0.0 (0.91)	0.5 (0.93)
Direct bilirubin, Month 3	-0.1 (0.64)	-0.5 (0.90)	0.0 (0.0)
Direct bilirubin, Month 4	-0.1 (0.51)	-0.1 (0.99)	0.8 (1.10)
Direct bilirubin, Month 5	0.1 (0.70)	-0.1 (0.70)	0.0 (0.0)
Direct bilirubin, Follow-up	-0.1 (1.00)	-0.2 (1.17)	0.4 (0.89)
Total bilirubin, Month 1	-0.7 (3.98)	-1.4 (2.02)	0.4 (2.26)
Total bilirubin, Month 2	0.3 (1.78)	0.2 (2.70)	0.5 (3.82)
Total bilirubin, Month 3	-1.2 (4.04)	-0.6 (2.50)	-2.0 (1.63)
Total bilirubin, Month 4	-0.3 (2.02)	-0.9 (1.52)	-0.4 (2.97)
Total bilirubin, Month 5	-0.7 (2.28)	-0.5 (2.50)	-2.0 (2.00)
Total bilirubin, Follow-up	-1.1 (2.43)	0.3 (2.97)	-0.8 (3.35)
Creatinine, Month 2	3.5 (9.65)	3.0 (9.23)	-5.0 (7.07)
Creatinine, Month 5	-0.5 (5.16)	2.3 (5.44)	-6.0 (5.20)
Creatinine, Follow-up	4.3 (8.65)	3.5 (8.66)	-7.0 (14.46)

8. Primary Outcome

Title	Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period
Description	Change from Baseline (Day 1) is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Calcium, chloride, carbon di oxide equivalent content (CO2), glucose, potassium, sodium, and urea/blood urea nitrogen (BUN) was recorded from Baseline up to Follow-up.
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Calcium, Month 2	0.000 (0.1006)	-0.020 (0.0840)	-0.050 (0.1189)
Calcium, Month 5	-0.006 (0.1105)	-0.045 (0.0934)	-0.100 (0.0917)
Calcium, Follow-up	-0.026 (0.0902)	-0.010 (0.0542)	-0.028 (0.1221)
Chloride, Month 2	0.1 (2.59)	-0.2 (1.99)	0.5 (1.77)
Chloride, Month 5	-0.3 (2.45)	0.5 (1.37)	-2.0 (1.73)
Chloride, Follow-up	0.0 (2.42)	0.1 (1.70)	-0.2 (2.59)
CO2, Month 2	-0.4 (2.17)	-1.3 (2.14)	-1.3 (2.60)
CO2, Month 5	0.3 (2.00)	-1.1 (2.07)	-1.0 (5.29)
CO2, Follow-up	-0.3 (2.67)	-0.6 (1.86)	-0.6 (3.91)
Glucose, Month 2	-0.26 (1.087)	0.46 (1.947)	0.95 (1.622)
Glucose, Month 5	-0.85 (1.167)	-0.03 (1.698)	1.70 (3.329)
Glucose, Follow-up	-0.16 (1.315)	0.22 (2.561)	0.34 (1.354)
Potassium, Month 2	-0.01 (0.341)	-0.02 (0.251)	-0.20 (0.385)
Potassium, Month 5	0.02 (0.544)	-0.11 (0.406)	-0.53 (0.404)
Potassium, Follow-up	-0.06 (0.410)	-0.06 (0.277)	-0.44 (0.114)
Sodium, Month 2	0.0 (1.81)	-1.0 (1.87)	0.3 (2.25)
Sodium, Month 5	-0.6 (2.58)	-1.1 (0.94)	-2.7 (1.53)
Sodium, Follow-up	-1.1 (2.77)	-1.2 (2.23)	-0.6 (0.55)
Urea/BUN, Month 2	-0.09 (1.417)	0.12 (1.267)	0.06 (1.130)
Urea/BUN, Month 5	0.11 (0.905)	0.67 (1.034)	-0.17 (0.764)
Urea/BUN, Follow-up	-0.36 (1.509)	0.40 (1.059)	1.00 (0.500)

9. Primary Outcome

Title	Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period
Description	Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. MCV was recorded from Baseline up to Follow-up.
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants available at the time of assessment were analyzed

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Month 2	0.1 (2.07)	-0.2 (1.20)	-1.1 (1.24)
Month 5	0.0 (1.95)	-0.6 (2.16)	-3.0 (0.00)
Follow-up	0.2 (2.10)	0.7 (1.20)	-2.8 (0.96)

10. Primary Outcome

Title	Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Description	Change from Baseline is the value at indicated time point minus the Baseline value. Baseline measurement was recorded at Day 1. Intra-ocular pressure was recorded from Baseline up to Follow-up.
Time Frame	Baseline (Day 1) and approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Month 1	0.2 (3.47)	0.7 (2.23)	1.3 (2.98)
Month 2	0.1 (3.46)	1.2 (2.83)	1.1 (3.18)
Month 3	-1.1 (4.07)	0.7 (2.64)	2.0 (4.69)
Month 4	-0.5 (2.35)	1.2 (2.71)	1.4 (5.86)
Month 5	-1.1 (3.60)	1.2 (2.59)	-0.3 (5.77)
Month Follow-up	-1.3 (3.13)	0.1 (2.72)	0.7 (3.50)

11. Primary Outcome

Title	Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Description	In this dipstick test, the level of blood occult and glucose, ketones, protein in urine samples were recorded as negative, trace, 1+, 2+, and 3+ (the plus sign increases with a higher level of glucose, ketones, or proteins in the urine: 1+=slightly positive, 2+=positive, 3+=high positive).
Time Frame	Approximately up to 6 months (up to follow-up)

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Urine blood occult, Month 2, 1+	0 0%	0 0%	1 12.5%
Urine blood occult, Month 2, traces	3 15.8%	2 13.3%	0 0%
Urine blood occult, Month 5, traces	0 0%	2 13.3%	0 0%
Urine blood occult, Follow-up, traces	1 5.3%	0 0%	0 0%
Urine glucose, Month 5, traces	0 0%	1 6.7%	0 0%
Urine glucose, Follow-up, 1+ OR 1/4/G/DL (5%)	0 0%	1 6.7%	0 0%
Urine ketones, Month 2, traces	1 5.3%	0 0%	0 0%
Urine ketones, Follow-up, traces	1 5.3%	1 6.7%	0 0%
Urine protein, Month 2, 1+	0 0%	0 0%	1 12.5%
Urine protein, Month 2, traces	3 15.8%	0 0%	0 0%
Urine protein, Month 5, 1+	0 0%	1 6.7%	1 12.5%
Urine protein, Follow-up, 1+	0 0%	1 6.7%	0 0%
Urine protein, Follow-up, traces	3 15.8%	2 13.3%	1 12.5%

12. Primary Outcome

Title	Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
Description	Number of participants with ocular and non-ocular AEs and SAEs were separately recorded. An AE is an unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain time period after the study has ended. This change may or may not be caused by the intervention being studied. An SAE is an adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
Time Frame	Approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Any AE, non-ocular	11 57.9%	9 60%	3 37.5%
Any SAE, non-ocular	2 10.5%	0 0%	0 0%
Any AE, ocular	8 42.1%	3 20%	2 25%
Any SAE, ocular	0 0%	1 6.7%	0 0%

13. Primary Outcome

Title	Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)
Description	Visual acuity was measured over 5 months and also during follow-up period. Visual acuity was measured using standardized early treatment of diabetic retinopathy study (ETDRS) visual acuity charts. Visual acuity measurement was performed by an examiner that had been appropriately trained. Screening, Month 2 and Month 5 data were considered as Best Corrected Visual Acuity (BCVA) data. A loss of greater than or equal to 15 letters in BCVA from Baseline was considered of PCI. Data for number of participants who met the criteria for PCI have been presented.
Time Frame	Approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population. Only those participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	2 10.5%	2 13.3%	0 0%

14. Primary Outcome

Title	Number of Participants With Abnormal Pupil Examination of PCI
Description	Pupil abnormalities were of different types. Meibomian gland dysfunction was measured as obvious inspissation (debris). Mild injection, no trichiasis (lid thickening), or two step worsening was analyzed. Afferent pupillary defect, motility examination, PERRL, confrontation visual field was measured as a new definite abnormality. Left and right both eyes were examined.
Time Frame	Up to follow-up (approximately 6 months)

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	2 10.5%	1 6.7%	1 12.5%

15. Primary Outcome

Title	Number of Participants With Abnormal Conjunctival Examination of PCI
Description	A two step worsening in the conjunctival examination was considered a value of PCI. Participants were analyzed for conjunctival examination up to follow-up (6 months).
Time Frame	Up to follow-up (approximately 6 months)

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	0 0%	0 0%	0 0%

16. Primary Outcome

Title	Number of Participants With Abnormal Anterior Chamber Examination of PCI
Description	A two step worsening in the anterior chamber examination was considered a value of PCI. The participants were examined for any anterior chamber abnormality. Fibrinous response and obvious aqueous haze were considered abnormalities related to anterior chamber examination.
Time Frame	Approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	0 0%	0 0%	0 0%

17. Primary Outcome

Title	Number of Participants With Abnormal Corneal Examination of PCI
Description	A two step change in any of the lens opacity categories was categorized as of PCI. Corneal epithelium was defined as abnormal when punctate keratopathy was measured as mild, moderate, severe; epithelial edema was measured as subtle epithelial haze, mild patchy microcystic changes, diffuse microcystic changes, and/or investigator determined abnormality. Stromal opacity/ edema was measured by investigator when stroma identifies opacity or edema. Corneal staining was measured as obvious (<=20) localized or diffuse punctate staining areas, severe localized or diffuse punctate staining. Participants were analyzed for any of the mentioned abnormality over 6 weeks (up to follow-up period).
Time Frame	Approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	2 10.5%	0 0%	0 0%

18. Primary Outcome

Title	Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale
Description	A two step change in any of the lens opacity categories was considered a value of PCI. Aphakia (surgical removal of lens) or pseudophakia was noted if any. Stroma opacity or edema was measured by investigator when it was detected as edema or opacity in stroma.
Time Frame	Approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	0 0%	1 6.7%	1 12.5%

19. Primary Outcome

Title	Number of Participants With Abnormal Tear Films of PCI
Description	Tear film abnormalities were based on the clinical judgment of investigator. Tear film thickness was analyzed and it was reported whether the film was increased or decreased or was normal. Presence of debris or mucus was also reported. Other test were tear lake analysis and checking of discharge from eyes.
Time Frame	Approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	3 15.8%	1 6.7%	1 12.5%

20. Primary Outcome

Title	Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function
Description	Meibomian gland dysfunction was measured as obvious insipisation/debris, mild injection, no trichiasis or lid thickening; inspisation, debris, obvious injection, lid thickening, may have trsichiasis; or a two step worsening. Any 2+ worsening of Meibomian gland function was considered a value of PCI.
Time Frame	Approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	1 5.3%	0 0%	1 12.5%

21. Primary Outcome

Title	Number of Participants With Abnormal (Dilated) Fundus Examination
Description	Dilation of fundus was examined post dosing up to 6 months. Number of participants with abnormal change from Baseline indicating dilation of fundus of eye was reported. Change from Baseline was the value at indicated time point minus the Baseline value. The abnormalities were posterior vitreous separation, pale optic nerve, fluid in the posterior pole, drusen, thick arterio-venous changes, pigment changes, cystoids, macular edema, drying of posterior fluid or sub-retinal fluid, underlying central atrophy, and retinal pigment epithelial changes etc. Refraction measurement were determined at the screening and 2 month/5 month visits in order to determine BCVA.
Time Frame	Approximately up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Count of Participants [Participants]	4 21.1%	1 6.7%	2 25%

22. Secondary Outcome

Title	Change From Baseline (Screening Visit) in BCVA at Month 2 and 5
Description	Change from Baseline in BCVA is the value at indicated time point minus the Baseline value. BCVA at screening visit was used as statistical Baseline. Only data before post-dose intravitreal injection of Avastin/ Lucentis (IVT) has been presented. Arithmetic mean was presented as data values; however statistical analysis is based on means of observed case (OC) data. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.
Time Frame	From Baseline (screening visit), Month 2, and Month 5

Outcome Measure Data

Analysis Population Description

Efficacy population included all participants in safety population who have classic choroidal neovascularization present as detected by fluorescein angiography in the previous screening visit.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	13	12	4
IVT Treatment naive, Month 2	0.1 (4.85)	-5.3 (6.24)	-0.7 (3.06)
IVT Treatment naive, Month 5	-5.6 (12.60)	-5.3 (6.70)	-3.0 (NA)
Previously treated with IVT, Month 2	-1.6 (4.28)	-3.5 (4.65)
Previously treated with IVT, Month 5	-1.3 (3.30)	-2.0 (7.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5 mg/mL TID
	Comments	Month 2 versus screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 95%; -3.18 to 2.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.362
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	5 mg/mL TID
	Comments	Month 5 versus screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-3.80
	Confidence Interval	(2-Sided) 95%; -7.13 to -0.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.659
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	2 mg/mL TID
	Comments	Month 2 versus screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.15
	Confidence Interval	(2-Sided) 95%; -7.52 to -0.78
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.672
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	2 mg/mL TID
	Comments	Month 5 versus screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.03
	Confidence Interval	(2-Sided) 95%; -7.53 to 0.53
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 1.740
	Estimation Comments

23. Secondary Outcome

Title	Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months
Description	The OCT effect is a pharmacodynamics (PD) measure of daily repeated dosing of Pazopanib. The anatomic effects of pazopanib treatment were limited to investigator determined assessment of OCT central subfield retinal thickness due to heterogeneity of participant population and the low likelihood of utility of central reading center determination. The OCT equipment used was approved by central OTC reading center. OCT scans were collected at indicated time points and were evaluated by Investigator. Thus, grading of further secondary objectives was not performed as per the study team. Change from Baseline is the value at indicated time point minus the Baseline value. The screening was used as a Baseline visit that was within or at 14 days of Day 1. Screening visit BCVA values were used to perform statistical comparison at month 2 and 5.
Time Frame	From Baseline (Screening visit) and up to 5 months

Outcome Measure Data

Analysis Population Description

Pharmacodynamic subpopulation included participants that were analyzed for PD outcome measures. Only the participants available at the time of assessment were analyzed.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	13	12	4
Treatment naive, Month 1	8.3 (48.19)	41.1 (99.51)	-18.0 (37.40)
Treatment naive, Month 2	16.3 (62.32)	18.3 (45.09)	3.0 (47.32)
Treatment naive, Month 3	-31.3 (43.43)	31.3 (61.36)	12.0 (5.66)
Treatment naive, Month 4	-19.2 (52.77)	-15.3 (41.28)	-168.5 (246.78)
Treatment naive, Month 5	-15.6 (52.13)	7.3 (45.11)	16.0 (NA)
Previously treated, Month 1	46.4 (130.30)	-1.3 (27.93)	36.0 (NA)
Previously treated, Month 2	-99.0 (180.74)	-10.0 (108.19)
Previously treated, Month 3	-66.2 (126.35)	2.0 (37.99)
Previously treated, Month 4	-86.8 (151.02)	0.3 (87.37)
Previously treated, Month 5	-55.5 (159.53)	3.0 (66.43)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	5 mg/mL TID
	Comments	For Month 1 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	8.28
	Confidence Interval	(2-Sided) 95%; -25.72 to 42.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 16.899
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	5 mg/mL TID
	Comments	Month 2 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.21
	Confidence Interval	(2-Sided) 95%; -35.73 to 33.31
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 17.177
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	5 mg/mL TID
	Comments	Month 3 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-5.11
	Confidence Interval	(2-Sided) 95%; -41.08 to 30.86
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 17.958
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	5 mg/mL TID
	Comments	Month 4 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-9.92
	Confidence Interval	(2-Sided) 95%; -47.83 to 28.00
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 18.996
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	5 mg/mL TID
	Comments	Month 5 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.42
	Confidence Interval	(2-Sided) 95%; -35.50 to 40.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 18.996
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	2 mg/mL TID
	Comments	Month 1 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	9.05
	Confidence Interval	(2-Sided) 95%; -33.09 to 51.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 20.931
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	2 mg/mL TID
	Comments	Month 2 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.24
	Confidence Interval	(2-Sided) 95%; -44.05 to 41.57
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 21.290
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	2 mg/mL TID
	Comments	Month 3 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	15.39
	Confidence Interval	(2-Sided) 95%; -28.28 to 59.06
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 21.757
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	2 mg/mL TID
	Comments	Month 4 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-16.82
	Confidence Interval	(2-Sided) 95%; -61.28 to 27.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 22.183
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	2 mg/mL TID
	Comments	Month 5 versus Screening visit
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.16
	Confidence Interval	(2-Sided) 95%; -45.83 to 41.51
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 21.757
	Estimation Comments

24. Secondary Outcome

Title	Change in Neo-vascular Size and Lesion Size Over Period
Description	The analysis was planned to be performed up to 6 months; however, due to heterogeneity of the population and the low likelihood of the utility of the data, the anatomic effects of the pazopanib treatment in this treatment were limited to investigator determined assessment of OCT central subfield retinal thickness. Thus, the study team decided not to have DARC (central reading center) perform the grading for the secondary PD outcomes like lesion size and change with respect to time were not analyzed. Thus, data was not collected for this outcome measure.
Time Frame	Up to 6 weeks

Outcome Measure Data

Analysis Population Description

PD population was planned for analysis of this outcome; however, Data was not collected for this outcome measure.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	0	0	0

25. Secondary Outcome

Title	Number of Participants With Lesion Types Over Period
Description	Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported.
Time Frame	Up to 6 months

Outcome Measure Data

Analysis Population Description

Safety population.

Arm/Group Title	5 mg/mL TID	2 mg/mL TID	5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.	Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months and were followed-up for 7-14 days after the last dose of the study drug.
Measure Participants	19	15	8
Occult	16 84.2%	11 73.3%	3 37.5%
Minimally classic	2 10.5%	4 26.7%	5 62.5%

Adverse Events

Time Frame	AEs and SAEs were collected approximately up to 6 months
Adverse Event Reporting Description	Safety Population was used to collect AE and SAE data
Arm/Group Title	5 mg/mL TID		2 mg/mL TID		5 mg/mL QD
Arm/Group Description	Eligible participants received 5 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.		Eligible participants received 2 mg/mL Pazopanib eye drops three times daily for a treatment period of five months.		Eligible participants received 5 mg/mL Pazopanib eye drops once daily for a treatment period of five months.
All Cause Mortality
	5 mg/mL TID		2 mg/mL TID		5 mg/mL QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/19 (0%)		0/15 (0%)		0/8 (0%)
Serious Adverse Events
	5 mg/mL TID		2 mg/mL TID		5 mg/mL QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/19 (10.5%)		1/15 (6.7%)		0/8 (0%)
Cardiac disorders
Acute coronary syndrome	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Eye disorders
Cataract	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Injury, poisoning and procedural complications
Wrist fracture	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Other (Not Including Serious) Adverse Events
	5 mg/mL TID		2 mg/mL TID		5 mg/mL QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	15/19 (78.9%)		9/15 (60%)		3/8 (37.5%)
Cardiac disorders
Angina pectoris	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Endocrine disorders
Hypothyroidism	0/19 (0%)		0/15 (0%)		1/8 (12.5%)
Eye disorders
Eye pain	2/19 (10.5%)		0/15 (0%)		0/8 (0%)
Keratoconjunctivitis sicca	1/19 (5.3%)		1/15 (6.7%)		0/8 (0%)
Macular degeneration	1/19 (5.3%)		1/15 (6.7%)		0/8 (0%)
Retinal disorder	2/19 (10.5%)		0/15 (0%)		0/8 (0%)
Retinal haemorrhage	1/19 (5.3%)		1/15 (6.7%)		0/8 (0%)
Blepharitis	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Cataract	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Cataract nuclear	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Dry eye	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Optic disc haemorrhage	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Photopsia	0/19 (0%)		0/15 (0%)		1/8 (12.5%)
Posterior capsule opacification	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Visual impairment	0/19 (0%)		0/15 (0%)		1/8 (12.5%)
Vitreous detachment	0/19 (0%)		0/15 (0%)		1/8 (12.5%)
Gastrointestinal disorders
Abdominal pain upper	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Diarrhoea	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Gastrooesophageal reflux disease	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
General disorders
Sensation of foreign body	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Hepatobiliary disorders
Cholelithiasis	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Immune system disorders
Seasonal allergy	0/19 (0%)		2/15 (13.3%)		0/8 (0%)
Infections and infestations
Upper respiratory tract infection	1/19 (5.3%)		0/15 (0%)		2/8 (25%)
Nasopharyngitis	1/19 (5.3%)		1/15 (6.7%)		0/8 (0%)
Cystitis	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Influenza	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Localised infection	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Lower respiratory tract infection	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Injury, poisoning and procedural complications
Ankle fracture	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Fall	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Muscle strain	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Wrist fracture	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Investigations
Blood cholesterol increased	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Blood glucose increased	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Metabolism and nutrition disorders
Hypercholesterolaemia	1/19 (5.3%)		1/15 (6.7%)		1/8 (12.5%)
Diabetes mellitus	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Muscle spasms	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Osteoporosis	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Psychiatric disorders
Depression	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Renal and urinary disorders
Haematuria	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Oropharyngeal pain	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Pulmonary congestion	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Skin and subcutaneous tissue disorders
Ecchymosis	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Rash	1/19 (5.3%)		0/15 (0%)		0/8 (0%)
Skin lesion	0/19 (0%)		1/15 (6.7%)		0/8 (0%)
Vascular disorders
Hypertension	0/19 (0%)		0/15 (0%)		1/8 (12.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.