ID

39507

Description

Study ID: 110852 Clinical Study ID: 110852 Study Title: MD7110852, A Phase 2b Dose-Ranging Study of Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01134055 Sponsor: GlaxoSmithKline Phase: Phase 2 Study Recruitment Status: Completed Generic Name: pazopanib eye drops, ranibizumab intravitreal injection, placebo Trade Name: pazopanib, ranibizumab Study Indication: Macular Degeneration

Keywords

Versions (1)
  1. 1/20/20 1/20/20 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 20, 2020

DOI

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License

Creative Commons BY-NC 3.0
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Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

English

Screen - ETDRS Refraction; ETDRS Visual Acuity; Intraocular Pressure Exam; External Ocular Exam; Pupil Exam; Motility Exam; Confrontation Visual Field

1 forms  
ETDRS Refraction
Description

ETDRS Refraction

Alias
UMLS CUI-1
C3899277
UMLS CUI-2
C0034949
Assessment date
Description

Assessment date

Data type

date

Alias
UMLS CUI [1]
C2985720
Sphere - Right Eye
Description

Sphere - Right Eye

Data type

float

Alias
UMLS CUI [1,1]
C0946401
UMLS CUI [1,2]
C0229089
Cylinder - Right Eye
Description

Cylinder - Right Eye

Data type

float

Alias
UMLS CUI [1,1]
C0946265
UMLS CUI [1,2]
C0229089
Axis - Right Eye
Description

Axis - Right Eye

Data type

integer

Alias
UMLS CUI [1,1]
C0429590
UMLS CUI [1,2]
C0229089
Sphere - Left Eye
Description

Sphere - Left Eye

Data type

float

Alias
UMLS CUI [1,1]
C0946401
UMLS CUI [1,2]
C0229090
Cylinder - Left Eye
Description

Cylinder - Left Eye

Data type

float

Alias
UMLS CUI [1,1]
C0946265
UMLS CUI [1,2]
C0229090
Axis - Left Eye
Description

Axis - Left Eye

Data type

integer

Alias
UMLS CUI [1,1]
C0429590
UMLS CUI [1,2]
C0229090
ETDRS Visual Acuity
Description

ETDRS Visual Acuity

Alias
UMLS CUI-1
C1275992
Assessment Date and Time
Description

Assessment Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Assessor's Certification Number
Description

Assessor's Certification Number

Data type

text

Alias
UMLS CUI [1,1]
C0007836
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C2646699
Total calculated visual acuity score - Right Eye
Description

Total calculated visual acuity score - Right Eye

Data type

integer

Alias
UMLS CUI [1,1]
C1275992
UMLS CUI [1,2]
C0229089
UMLS CUI [1,3]
C0444686
Snellen/Acuity Equivalent - Right Eye
Description

Snellen/Acuity Equivalent - Right Eye

Data type

integer

Alias
UMLS CUI [1,1]
C1827708
UMLS CUI [1,2]
C0229089
If performed at 4 Meters, specify
Description

If performed at 4 Meters, specify

Data type

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229089
If performed at 1 Meter, specify
Description

If performed at 1 Meter, specify

Data type

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229089
Light Perception - Right Eye
Description

Light Perception - Right Eye

Data type

integer

Alias
UMLS CUI [1,1]
C1154616
UMLS CUI [1,2]
C0229089
Total calculated visual acuity score - Left Eye
Description

Total calculated visual acuity score - Left Eye

Data type

text

Alias
UMLS CUI [1,1]
C1275992
UMLS CUI [1,2]
C0229090
UMLS CUI [1,3]
C0444686
Snellen/Acuity Equivalent - Left Eye
Description

Snellen/Acuity Equivalent - Left Eye

Data type

integer

Alias
UMLS CUI [1,1]
C1827708
UMLS CUI [1,2]
C0229090
If performed at 4 Meters, specify
Description

If performed at 4 Meters, specify

Data type

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
If performed at 1 Meter, specify
Description

If performed at 1 Meter, specify

Data type

integer

Alias
UMLS CUI [1,1]
C0442746
UMLS CUI [1,2]
C0229090
Light Perception - Left Eye
Description

Light Perception - Left Eye

Data type

integer

Alias
UMLS CUI [1,1]
C1154616
UMLS CUI [1,2]
C0229090
Intraocular Pressure Exam
Description

Intraocular Pressure Exam

Alias
UMLS CUI-1
C0430888
Intraocular Pressure Exam - Assessment Date and Time
Description

Intraocular Pressure Exam - Assessment Date and Time

Data type

datetime

Alias
UMLS CUI [1,1]
C0430888
UMLS CUI [1,2]
C2985720
UMLS CUI [1,3]
C1264639
Intraocular Pressure Measurement - Right Eye
Description

Intraocular Pressure Measurement - Right Eye

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0040420
UMLS CUI [1,2]
C0229089
mm[Hg]
Intraocular Pressure Measurement - Left Eye
Description

Intraocular Pressure Measurement - Left Eye

Data type

integer

Measurement units
  • mm[Hg]
Alias
UMLS CUI [1,1]
C0040420
UMLS CUI [1,2]
C0229090
mm[Hg]
External Ocular Exam
Description

External Ocular Exam

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C1299003
External Ocular Exam - Assessment date
Description

External Ocular Exam - Assessment date

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C1299003
UMLS CUI [1,3]
C2985720
Pupil Exam - Right Eye
Description

Pupil Exam - Right Eye

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0034121
UMLS CUI-3
C0229089
Pupils are equal, round, and reactive to light (PERRL)
Description

Pupils are equal, round, and reactive to light (PERRL)

Data type

text

Alias
UMLS CUI [1,1]
C0034121
UMLS CUI [1,2]
C0205163
UMLS CUI [2,1]
C0034121
UMLS CUI [2,2]
C0332490
UMLS CUI [3,1]
C0034121
UMLS CUI [3,2]
C0205332
If other pupil finding, specify
Description

If other pupil finding, specify

Data type

text

Alias
UMLS CUI [1,1]
C0034121
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Afferent pupillary defect (APD) - Right Eye
Description

Afferent pupillary defect (APD) - Right Eye

Data type

integer

Alias
UMLS CUI [1,1]
C0339662
UMLS CUI [1,2]
C0229089
Pupil Exam - Left Eye
Description

Pupil Exam - Left Eye

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0034121
UMLS CUI-3
C0229090
Pupils are equal, round, and reactive to light (PERRL)
Description

Pupils are equal, round, and reactive to light (PERRL)

Data type

text

Alias
UMLS CUI [1,1]
C0034121
UMLS CUI [1,2]
C0205163
UMLS CUI [2,1]
C0034121
UMLS CUI [2,2]
C0332490
UMLS CUI [3,1]
C0034121
UMLS CUI [3,2]
C0205332
If other pupil finding, specify
Description

If other pupil finding, specify

Data type

text

Alias
UMLS CUI [1,1]
C0034121
UMLS CUI [1,2]
C0243095
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C2348235
Afferent pupillary defect (APD) - Left Eye
Description

Afferent pupillary defect (APD) - Left Eye

Data type

integer

Alias
UMLS CUI [1,1]
C0339662
UMLS CUI [1,2]
C0229090
Motility Exam
Description

Motility Exam

Alias
UMLS CUI-1
C1510470
Motility Exam - Right Eye
Description

Motility Exam - Right Eye

Data type

integer

Alias
UMLS CUI [1,1]
C1510470
UMLS CUI [1,2]
C0229089
Motility Exam - Left Eye
Description

Motility Exam - Left Eye

Data type

integer

Alias
UMLS CUI [1,1]
C1510470
UMLS CUI [1,2]
C0229089
Confrontation Visual Field
Description

Confrontation Visual Field

Alias
UMLS CUI-1
C1444674
Eye full to confrontation - Right Eye
Description

Eye full to confrontation - Right Eye

Data type

integer

Alias
UMLS CUI [1]
C2053834
If other Confrontation Visual Field, specify - Right Eye
Description

If other Confrontation Visual Field, specify - Right Eye

Data type

text

Alias
UMLS CUI [1,1]
C1444674
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
UMLS CUI [1,4]
C0229089
Eye full to confrontation - Left Eye
Description

Eye full to confrontation - Left Eye

Data type

integer

Alias
UMLS CUI [1]
C2053833
If other Confrontation Visual Field, specify - Left Eye
Description

If other Confrontation Visual Field, specify - Left Eye

Data type

text

Alias
UMLS CUI [1,1]
C1444674
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C2348235
UMLS CUI [1,4]
C0229090
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Similar models

Screen - ETDRS Refraction; ETDRS Visual Acuity; Intraocular Pressure Exam; External Ocular Exam; Pupil Exam; Motility Exam; Confrontation Visual Field

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
ETDRS Refraction
C3899277 (UMLS CUI-1)
C0034949 (UMLS CUI-2)
Assessment date
Item
Assessment date
date
C2985720 (UMLS CUI [1])
Sphere - Right Eye
Item
Sphere - Right Eye
float
C0946401 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Cylinder - Right Eye
Item
Cylinder - Right Eye
float
C0946265 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Axis - Right Eye
Item
Axis - Right Eye
integer
C0429590 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Sphere - Left Eye
Item
Sphere - Left Eye
float
C0946401 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Cylinder - Left Eye
Item
Cylinder - Left Eye
float
C0946265 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Axis - Left Eye
Item
Axis - Left Eye
integer
C0429590 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Item Group
ETDRS Visual Acuity
C1275992 (UMLS CUI-1)
Assessment Date and Time
Item
Assessment Date and Time
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Assessor's Certification Number
Item
Assessor's Certification Number
text
C0007836 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C2646699 (UMLS CUI [1,3])
Total calculated visual acuity score - Right Eye
Item
Total calculated visual acuity score - Right Eye
integer
C1275992 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
C0444686 (UMLS CUI [1,3])
Item
Snellen/Acuity Equivalent - Right Eye
integer
C1827708 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Snellen/Acuity Equivalent - Right Eye
Code List
Snellen/Acuity Equivalent - Right Eye
CL Item
Performed at 4 Meters (4)
CL Item
Performed at 1 Meter (1)
Item
If performed at 4 Meters, specify
integer
C0442746 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
If performed at 4 Meters, specify
Code List
If performed at 4 Meters, specify
CL Item
20/200 (0401)
CL Item
20/160 (0402)
CL Item
20/125 (0403)
CL Item
20/100 (0404)
CL Item
20/80 (0405)
CL Item
20/63 (0406)
CL Item
20/50 (0407)
CL Item
20/40 (0408)
CL Item
20/32 (0409)
CL Item
20/25 (0410)
CL Item
20/20 (0411)
CL Item
20/16 (0412)
CL Item
20/12.5 (0415)
CL Item
20/10 (0414)
Item
If performed at 1 Meter, specify
integer
C0442746 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
If performed at 1 Meter, specify
Code List
If performed at 1 Meter, specify
CL Item
20/800 (0101)
CL Item
20/640 (0102)
CL Item
20/500 (0103)
CL Item
20/400 (0104)
CL Item
20/320 (0105)
CL Item
20/350 (0106)
Item
Light Perception - Right Eye
integer
C1154616 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Light Perception - Right Eye
Code List
Light Perception - Right Eye
CL Item
Not applicable (4)
CL Item
No light perception (0)
CL Item
Light perception (1)
CL Item
Perceives hand motions (2)
CL Item
Counts fingers (3)
Total calculated visual acuity score - Left Eye
Item
Total calculated visual acuity score - Left Eye
text
C1275992 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
C0444686 (UMLS CUI [1,3])
Item
Snellen/Acuity Equivalent - Left Eye
integer
C1827708 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Snellen/Acuity Equivalent - Left Eye
Code List
Snellen/Acuity Equivalent - Left Eye
CL Item
Performed at 4 Meters  (4)
CL Item
Performed at 1 Meter (1)
Item
If performed at 4 Meters, specify
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
undefined item
Code List
If performed at 4 Meters, specify
CL Item
20/200 (0401)
CL Item
20/160 (0402)
CL Item
20/125 (0403)
CL Item
20/100 (0404)
CL Item
20/80 (0405)
CL Item
20/63 (0406)
CL Item
20/50 (0407)
CL Item
20/40 (0408)
CL Item
20/32 (0409)
CL Item
20/25 (0410)
CL Item
20/20 (0411)
CL Item
20/16 (0412)
CL Item
20/12.5 (0415)
CL Item
20/10 (0414)
Item
If performed at 1 Meter, specify
integer
C0442746 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
If performed at 1 Meter, specify
Code List
If performed at 1 Meter, specify
CL Item
20/800 (0101)
CL Item
20/640 (0102)
CL Item
20/500 (0103)
CL Item
20/400 (0104)
CL Item
20/320 (0105)
CL Item
20/350 (0106)
Item
Light Perception - Left Eye
integer
C1154616 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Light Perception - Left Eye
Code List
Light Perception - Left Eye
CL Item
Not applicable  (4)
CL Item
No light perception  (0)
CL Item
Light perception  (1)
CL Item
Perceives hand motions  (2)
CL Item
Counts fingers (3)
Item Group
Intraocular Pressure Exam
C0430888 (UMLS CUI-1)
Intraocular Pressure Exam - Assessment Date and Time
Item
Intraocular Pressure Exam - Assessment Date and Time
datetime
C0430888 (UMLS CUI [1,1])
C2985720 (UMLS CUI [1,2])
C1264639 (UMLS CUI [1,3])
Intraocular Pressure Measurement - Right Eye
Item
Intraocular Pressure Measurement - Right Eye
integer
C0040420 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Intraocular Pressure Measurement - Left Eye
Item
Intraocular Pressure Measurement - Left Eye
integer
C0040420 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Item Group
External Ocular Exam
C0031809 (UMLS CUI-1)
C1299003 (UMLS CUI-2)
External Ocular Exam - Assessment date
Item
External Ocular Exam - Assessment date
date
C0031809 (UMLS CUI [1,1])
C1299003 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,3])
Item Group
Pupil Exam - Right Eye
C0031809 (UMLS CUI-1)
C0034121 (UMLS CUI-2)
C0229089 (UMLS CUI-3)
Item
Pupils are equal, round, and reactive to light (PERRL)
text
C0034121 (UMLS CUI [1,1])
C0205163 (UMLS CUI [1,2])
C0034121 (UMLS CUI [2,1])
C0332490 (UMLS CUI [2,2])
C0034121 (UMLS CUI [3,1])
C0205332 (UMLS CUI [3,2])
Pupils are equal, round, and reactive to light (PERRL)
Code List
Pupils are equal, round, and reactive to light (PERRL)
CL Item
Normal (1)
CL Item
Abnormal (2)
CL Item
Post-surgical  (PERRLPSU)
CL Item
Other, Specify (?)
If other pupil finding, specify
Item
If other pupil finding, specify
text
C0034121 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Afferent pupillary defect (APD) - Right Eye
integer
C0339662 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Afferent pupillary defect (APD) - Right Eye
Code List
Afferent pupillary defect (APD) - Right Eye
CL Item
Present (1)
CL Item
Absent (2)
Item Group
Pupil Exam - Left Eye
C0031809 (UMLS CUI-1)
C0034121 (UMLS CUI-2)
C0229090 (UMLS CUI-3)
Item
Pupils are equal, round, and reactive to light (PERRL)
text
C0034121 (UMLS CUI [1,1])
C0205163 (UMLS CUI [1,2])
C0034121 (UMLS CUI [2,1])
C0332490 (UMLS CUI [2,2])
C0034121 (UMLS CUI [3,1])
C0205332 (UMLS CUI [3,2])
Pupils are equal, round, and reactive to light (PERRL)
Code List
Pupils are equal, round, and reactive to light (PERRL)
CL Item
Normal  (1)
CL Item
Abnormal  (2)
CL Item
Post-surgical  (PERRLPSU)
CL Item
Other, Specify (?)
If other pupil finding, specify
Item
If other pupil finding, specify
text
C0034121 (UMLS CUI [1,1])
C0243095 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
Item
Afferent pupillary defect (APD) - Left Eye
integer
C0339662 (UMLS CUI [1,1])
C0229090 (UMLS CUI [1,2])
Afferent pupillary defect (APD) - Left Eye
Code List
Afferent pupillary defect (APD) - Left Eye
CL Item
Present  (1)
CL Item
Absent (2)
Item Group
Motility Exam
C1510470 (UMLS CUI-1)
Item
Motility Exam - Right Eye
integer
C1510470 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Motility Exam - Right Eye
Code List
Motility Exam - Right Eye
CL Item
Normal (1)
CL Item
Abnormal, Specify (2)
Item
Motility Exam - Left Eye
integer
C1510470 (UMLS CUI [1,1])
C0229089 (UMLS CUI [1,2])
Motility Exam - Left Eye
Code List
Motility Exam - Left Eye
CL Item
Normal  (1)
CL Item
Abnormal, Specify (2)
Item Group
Confrontation Visual Field
C1444674 (UMLS CUI-1)
Item
Eye full to confrontation - Right Eye
integer
C2053834 (UMLS CUI [1])
Eye full to confrontation - Right Eye
Code List
Eye full to confrontation - Right Eye
CL Item
Normal (1)
CL Item
Abnormal, specify (2)
If other Confrontation Visual Field, specify - Right Eye
Item
If other Confrontation Visual Field, specify - Right Eye
text
C1444674 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0229089 (UMLS CUI [1,4])
Item
Eye full to confrontation - Left Eye
integer
C2053833 (UMLS CUI [1])
Eye full to confrontation - Left Eye
Code List
Eye full to confrontation - Left Eye
CL Item
Normal  (1)
CL Item
Abnormal, specify (2)
If other Confrontation Visual Field, specify - Left Eye
Item
If other Confrontation Visual Field, specify - Left Eye
text
C1444674 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,3])
C0229090 (UMLS CUI [1,4])
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