Macular DegenerationPhase 2NCT00733304
An Extension to Study MD7108240
A Phase 2 study testing Pazopanib in people with Macular Degeneration, run by GlaxoSmithKline at 17 sites in 3 countries.
Trial summary
This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Pazopanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 25 Jun 2008to 9 Sep 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States8 sites
GSK Investigational Site
Ann Arbor, Michigan, 48105
GSK Investigational Site
Beverly Hills, California, 90211
GSK Investigational Site
Boston, Massachusetts, 02111
GSK Investigational Site
Grand Rapids, Michigan, 49525
GSK Investigational Site
Indianapolis, Indiana, 46280
GSK Investigational Site
Sacramento, California, 95841
GSK Investigational Site
Salt Lake City, Utah, 84132
GSK Investigational Site
Winter Haven, Florida, 33880
Italy5 sites
GSK Investigational Site
Florence, Tuscany, 50134
GSK Investigational Site
Milan, Lombardy, 20132
GSK Investigational Site
Milan, Lombardy, 20157
GSK Investigational Site
Padova, Veneto, 35128
GSK Investigational Site
Turin, Piedmont, 10122
Australia4 sites
GSK Investigational Site
Melbourne, Victoria
GSK Investigational Site
Perth, Western Australia, 6009
GSK Investigational Site
Sydney, New South Wales, 2145
GSK Investigational Site
Sydney, New South Wales, 2150
About this study
Official title: An Extension Study to Protocol MD7108240: Pazopanib Eye Drops in Subjects With Neovascular Age-related Macular Degeneration
This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months.
- Conditions
- Macular Degeneration
- Being tested
- Pazopanib
- Keywords
- age-related macular degeneration (AMD), choroidal neovascularization (CNV), vascular endothelial growth factor (VEGF), pazopanib, angiogenesis
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD
| Study group | Role | What they receive |
|---|---|---|
| 5 mg/ml TID | Experimental | eligible participants received 5 mg/ml Pazopanib eye drops three times daily (TID) Receives: Drug: Pazopanib |
| 2 mg/ml TID | Experimental | eligible participants received 2 mg/ml Pazopanib eye drops three times daily Receives: Drug: Pazopanib |
| 5 mg/ml QD | Experimental | eligible participants received 5 mg/ml Pazopanib eye drops once daily (QD) Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period
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.
Measured: Baseline (Day 1) and approximately up to 6 months
Change From Baseline (Day 1) in Heart Rate Over Period
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.
Measured: Baseline (Day 1) and approximately up to 6 months
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
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.
Measured: Baseline (Day 1), Month 2, 5 and approximately up to Month 6
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period
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.
Measured: Baseline (Day 1) and approximately up to 6 months
Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period
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.
Measured: Baseline (Day 1) and approximately up to 6 months
Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period
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.
Measured: Baseline (Day 1) and approximately up to 6 months
Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period
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
Measured: Baseline (Day 1) and approximately up to 6 months
Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period
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.
Measured: Baseline (Day 1) and approximately up to 6 months
Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period
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.
Measured: Baseline (Day 1) and approximately up to 6 months
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
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.
Measured: Baseline (Day 1) and approximately up to 6 months
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
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).
Measured: Approximately up to 6 months (up to follow-up)
Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
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.
Measured: Approximately up to 6 months
Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)
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.
Measured: Approximately up to 6 months
Number of Participants With Abnormal Pupil Examination of PCI
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.
Measured: Up to follow-up (approximately 6 months)
Number of Participants With Abnormal Conjunctival Examination of PCI
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).
Measured: Up to follow-up (approximately 6 months)
Number of Participants With Abnormal Anterior Chamber Examination of PCI
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.
Measured: Approximately up to 6 months
Number of Participants With Abnormal Corneal Examination of PCI
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).
Measured: Approximately up to 6 months
Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale
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.
Measured: Approximately up to 6 months
Number of Participants With Abnormal Tear Films of PCI
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.
Measured: Approximately up to 6 months
Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function
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.
Measured: Approximately up to 6 months
Number of Participants With Abnormal (Dilated) Fundus Examination
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.
Measured: Approximately up to 6 months
Secondary outcomes (4)
Change From Baseline (Screening Visit) in BCVA at Month 2 and 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.
Measured: From Baseline (screening visit), Month 2, and Month 5
Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 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.
Measured: From Baseline (Screening visit) and up to 5 months
Change in Neo-vascular Size and Lesion Size Over Period
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.
Measured: Up to 6 weeks
Number of Participants With Lesion Types Over Period
Number of participants with type of lesion were reported as determined by Investigator. Occult and minimally classic were the two types of lesions reported.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study start25 Jun 2008
- Primary completion9 Sep 2009
- Study completion9 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular DegenerationStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733304
- Sponsor's protocol ID
- MD7111396
- Status last verified
- Oct 2017
- First submitted
- 12 Aug 2008
- Last updated
- 5 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension Study to Protocol MD7108240: Pazopanib Eye Drops in Subjects With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00733304
- Acronym / sponsor ID
- MD7111396
- Conditions
- Macular Degeneration
- Keywords
- age-related macular degeneration (AMD), choroidal neovascularization (CNV), vascular endothelial growth factor (VEGF), pazopanib, angiogenesis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2008 (actual)
- Primary completion
- 9 Sep 2009 (actual)
- Study completion
- 9 Sep 2009 (actual)
- First posted
- 13 Aug 2008 (estimated)
- Results
- Posted 5 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a two month study to allow continued treatment with pazopanib eye drops. Study may be extended to 5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5 mg/ml TID | Experimental | Drug: Pazopanibeligible participants received 5 mg/ml Pazopanib eye drops three times daily (TID) |
| 2 mg/ml TID | Experimental | Drug: Pazopanibeligible participants received 2 mg/ml Pazopanib eye drops three times daily |
| 5 mg/ml QD | Experimental | Drug: Pazopanibeligible participants received 5 mg/ml Pazopanib eye drops once daily (QD) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.)
Key exclusion criteria (16 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pazopanib5 mg/ml TID, 2 mg/ml TID or 5 mg/ml QD | Drug | 2 mg/ml TID, 5 mg/ml QD, 5 mg/ml TID |
Primary outcome
Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period
Time frame: 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.
Change From Baseline (Day 1) in Heart Rate Over Period
Time frame: 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.
Change From Baseline (Day 1) in Albumin and Hemoglobin Over Period
Time frame: 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.
Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferases (ALT), and Aspartate Aminotransferases (AST) Over Period
Time frame: 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.
Change From Baseline (Day 1) in Basophils, Eosinophils, Lymphocytes, Monocytes, Platelets, and White Blood Cell Count Over Period
Time frame: 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.
Change From Baseline (Day 1) in Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Over Period
Time frame: 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.
Change From Baseline (Day 1) in Direct Bilirubin, Total Bilirubin, and Creatinine Over Period
Time frame: 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
Change From Baseline in Calcium, Chloride, Carbon di Oxide Equivalent Content, Glucose, Potassium, Sodium, and Urea Blood Urea Nitrogen (BUN) Over Period
Time frame: 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.
Change From Baseline (Day 1) in Mean Corpuscular Volume (MCV) Over Period
Time frame: 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.
Change From Baseline (Day 1) in Intra-ocular Pressure Assessment Over Period
Time frame: 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.
Number of Participants With Blood Occult, Urine Glucose, Urine Ketones, and Urine Proteins by Dip Stick Analysis
Time frame: 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).
Number of Participants With Adverse Events (AEs)and Serious Adverse Events (SAEs)
Time frame: 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.
Number of Participants With Abnormal Visual Acuity of Potential Clinical Concern (PCI)
Time frame: 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.
Number of Participants With Abnormal Pupil Examination of PCI
Time frame: 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.
Number of Participants With Abnormal Conjunctival Examination of PCI
Time frame: 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).
Number of Participants With Abnormal Anterior Chamber Examination of PCI
Time frame: 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.
Number of Participants With Abnormal Corneal Examination of PCI
Time frame: 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).
Number of Participants With Abnormal Lens Opacity of PCI Using Age Related Eye Disease Study (AREDS) Scale
Time frame: 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.
Number of Participants With Abnormal Tear Films of PCI
Time frame: 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.
Number of Participants With Any Grade 2 Plus Worsening of Meibomian Gland Function
Time frame: 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.
Number of Participants With Abnormal (Dilated) Fundus Examination
Time frame: 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.
4 secondary outcomes
Change From Baseline (Screening Visit) in BCVA at Month 2 and 5
Time frame: From Baseline (screening visit), Month 2, and Month 5
Change From Baseline (Screening Visit) in Optical Coherence Tomography (OCT) Central Subfield Over 5 Months
Time frame: From Baseline (Screening visit) and up to 5 months
Change in Neo-vascular Size and Lesion Size Over Period
Time frame: Up to 6 weeks
Number of Participants With Lesion Types Over Period
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pazopanib in people with Macular Degeneration, run by GlaxoSmithKline at 17 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Italy, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (Day 1) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Over Period (time frame: Baseline (Day 1) and approximately up to 6 months). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.