ID

39971

Beschreibung

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

Stichworte

Versionen (2)
  1. 06.03.20 06.03.20 -
  2. 06.03.20 06.03.20 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

6. März 2020

DOI

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Creative Commons BY-NC 4.0
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Pazopanib Eye Drops versus Ranibizumab Intravitreal Injections for the Treatment of Neovascular Age-Related Macular Degeneration NCT01134055

Englisch

Week 8; 12; 16; 20; 28; 32; 36; 40; 44 - Investigational Product (Eye Drops) Returned, Dispensed; Ranibizumab Re-Injection; Monthly Ranibizumab Injection

1 Formulare  
Investigational Product (Eye Drops) - Returned
Beschreibung

Investigational Product (Eye Drops) - Returned

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0015399
UMLS CUI-3
C0332156
Date returned
Beschreibung

Date returned

Datentyp

date

Alias
UMLS CUI [1,1]
C0332156
UMLS CUI [1,2]
C0011008
Investigational product container number - Returned
Beschreibung

Investigational product container number - Returned

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
UMLS CUI [2]
C0332156
Vials - Returned
Beschreibung

Vials - Returned

Alias
UMLS CUI-1
C0184301
UMLS CUI-2
C0332156
Opened vials returned
Beschreibung

Opened vials returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0175566
UMLS CUI [2]
C2699071
Unopened vials returned
Beschreibung

Unopened vials returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0587267
UMLS CUI [2]
C2699071
Foils - Returned
Beschreibung

Foils - Returned

Alias
UMLS CUI-1
C1551385
UMLS CUI-2
C0332156
Opened number 1 foils returned
Beschreibung

Opened number 1 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C2699071
Unopened number 1 foils returned
Beschreibung

Unopened number 1 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0587267
UMLS CUI [2]
C2699071
Opened number 2 foils returned
Beschreibung

Opened number 2 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C2699071
Unopened number 2 foils returned
Beschreibung

Unopened number 2 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0587267
UMLS CUI [2]
C2699071
Opened number 3 foils returned
Beschreibung

Opened number 3 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C2699071
Unopened number 3 foils returned
Beschreibung

Unopened number 3 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0587267
UMLS CUI [2]
C2699071
Opened number 4 foils returned
Beschreibung

Opened number 4 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C2699071
Unopened number 4 foils returned
Beschreibung

Unopened number 4 foils returned

Datentyp

integer

Alias
UMLS CUI [1,1]
C1551385
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C0587267
UMLS CUI [2]
C2699071
Investigational Product (Eye Drops) - Dispensed
Beschreibung

Investigational Product (Eye Drops) - Dispensed

Alias
UMLS CUI-1
C0304229
UMLS CUI-2
C0015399
UMLS CUI-3
C0947323
Date dispensed
Beschreibung

Date dispensed

Datentyp

date

Alias
UMLS CUI [1,1]
C0947323
UMLS CUI [1,2]
C0011008
Investigational product container number - Dispesed
Beschreibung

Investigational product container number - Dispesed

Datentyp

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0180098
UMLS CUI [1,3]
C0600091
UMLS CUI [2]
C0947323
Ranibizumab Re-Injection
Beschreibung

Ranibizumab Re-Injection

Alias
UMLS CUI-1
C1566537
UMLS CUI-2
C1272883
Did the subject receive a ranibizumab re-injection?
Beschreibung

Did the subject receive a ranibizumab re-injection?

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C1272883
Date/Time of ranibizumab injection in the study eye
Beschreibung

Date/Time of ranibizumab injection in the study eye

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C1272883
UMLS CUI [2]
C0011008
UMLS CUI [3]
C0040223
Reason for re-injection
Beschreibung

Check all that apply

Datentyp

text

Alias
UMLS CUI [1,1]
C1272883
UMLS CUI [1,2]
C0392360
If other reason for re-injection, specify
Beschreibung

If other reason for re-injection, specify

Datentyp

text

Alias
UMLS CUI [1,1]
C1272883
UMLS CUI [1,2]
C0392360
UMLS CUI [2]
C0205394
UMLS CUI [3]
C2348235
Monthly Ranibizumab Injection
Beschreibung

Monthly Ranibizumab Injection

Alias
UMLS CUI-1
C1566537
UMLS CUI-2
C1272883
UMLS CUI-3
C0332177
Date and Time of ranibizumab injection in the study eye
Beschreibung

Date and Time of ranibizumab injection in the study eye

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1566537
UMLS CUI [1,2]
C1272883
UMLS CUI [1,3]
C0011008
UMLS CUI [1,4]
C0040223
UMLS CUI [2,1]
C0008972
UMLS CUI [2,2]
C0015392
Have you observed any of the following findings?
Beschreibung

Select all that apply

Datentyp

integer

Alias
UMLS CUI [1]
C0243095
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Ähnliche Modelle

Week 8; 12; 16; 20; 28; 32; 36; 40; 44 - Investigational Product (Eye Drops) Returned, Dispensed; Ranibizumab Re-Injection; Monthly Ranibizumab Injection

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Investigational Product (Eye Drops) - Returned
C0304229 (UMLS CUI-1)
C0015399 (UMLS CUI-2)
C0332156 (UMLS CUI-3)
Date returned
Item
Date returned
date
C0332156 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational product container number - Returned
Item
Investigational product container number - Returned
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0332156 (UMLS CUI [2])
Item Group
Vials - Returned
C0184301 (UMLS CUI-1)
C0332156 (UMLS CUI-2)
Opened vials returned
Item
Opened vials returned
integer
C0184301 (UMLS CUI [1,1])
C0175566 (UMLS CUI [1,2])
C2699071 (UMLS CUI [2])
Unopened vials returned
Item
Unopened vials returned
integer
C0184301 (UMLS CUI [1,1])
C0587267 (UMLS CUI [1,2])
C2699071 (UMLS CUI [2])
Item Group
Foils - Returned
C1551385 (UMLS CUI-1)
C0332156 (UMLS CUI-2)
Opened number 1 foils returned
Item
Opened number 1 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Unopened number 1 foils returned
Item
Unopened number 1 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0587267 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Opened number 2 foils returned
Item
Opened number 2 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Unopened number 2 foils returned
Item
Unopened number 2 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0587267 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Opened number 3 foils returned
Item
Opened number 3 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Unopened number 3 foils returned
Item
Unopened number 3 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0587267 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Opened number 4 foils returned
Item
Opened number 4 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Unopened number 4 foils returned
Item
Unopened number 4 foils returned
integer
C1551385 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C0587267 (UMLS CUI [1,3])
C2699071 (UMLS CUI [2])
Item Group
Investigational Product (Eye Drops) - Dispensed
C0304229 (UMLS CUI-1)
C0015399 (UMLS CUI-2)
C0947323 (UMLS CUI-3)
Date dispensed
Item
Date dispensed
date
C0947323 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigational product container number - Dispesed
Item
Investigational product container number - Dispesed
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
C0947323 (UMLS CUI [2])
Item Group
Ranibizumab Re-Injection
C1566537 (UMLS CUI-1)
C1272883 (UMLS CUI-2)
Did the subject receive a ranibizumab re-injection?
Item
Did the subject receive a ranibizumab re-injection?
boolean
C1566537 (UMLS CUI [1,1])
C1272883 (UMLS CUI [1,2])
Date/Time of ranibizumab injection in the study eye
Item
Date/Time of ranibizumab injection in the study eye
datetime
C1566537 (UMLS CUI [1,1])
C1272883 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2])
C0040223 (UMLS CUI [3])
Item
Reason for re-injection
text
C1272883 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Reason for re-injection
Code List
Reason for re-injection
CL Item
Evidence of intraretinal fluid or subretinal fluid (subfoveal and extrafoveal accumulations) (9)
CL Item
A serous retinal pigment epithelial detachment (PED) that would benefit from re-injection  (10)
CL Item
Notable decline in VA (a decrease of > 5 letters from any earlier maximum VA during the study if, in the opinion of the investigator, the VA decline is due to neovascular AMD) (3)
CL Item
New subretinal or intraretinal macular hemorrhage (11)
CL Item
Increased lesion size on FA relative to the last angiogram (5)
CL Item
Leakage on FA that would benefit from re-injection (12)
CL Item
Other, specify (OT)
If other reason for re-injection, specify
Item
If other reason for re-injection, specify
text
C1272883 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [2])
C2348235 (UMLS CUI [3])
Item Group
Monthly Ranibizumab Injection
C1566537 (UMLS CUI-1)
C1272883 (UMLS CUI-2)
C0332177 (UMLS CUI-3)
Date and Time of ranibizumab injection in the study eye
Item
Date and Time of ranibizumab injection in the study eye
datetime
C1566537 (UMLS CUI [1,1])
C1272883 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C0008972 (UMLS CUI [2,1])
C0015392 (UMLS CUI [2,2])
Item
Have you observed any of the following findings?
integer
C0243095 (UMLS CUI [1])
Have you observed any of the following findings?
Code List
Have you observed any of the following findings?
CL Item
Evidence of intraretinal fluid or subretinal fluid (subfoveal and extrafoveal accumulations) (9)
CL Item
A serous retinal pigment epithelial detachment (PED) that would benefit from ongoing injections  (13)
CL Item
Notable decline in VA (a decrease of > 5 letters from any earlier maximum VA during the study if, in the opinion of the investigator, the VA decline is due to neovascular AMD) (3)
CL Item
New subretinal or intraretinal macular hemorrhage (11)
CL Item
Increased lesion size relative to last angiogram (if FA was performed) (5)
CL Item
Leakage that would benefit from ongoing injections (if FA was performed) (14)
CL Item
None (8)
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