ID

5103

Description

ODM derived from http://clinicaltrials.gov/show/NCT01229215

Link

http://clinicaltrials.gov/show/NCT01229215

Keywords

Versions (2)
  1. 2/12/13 2/12/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
Uploaded on

April 19, 2014

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01229215 Geographic Atrophy

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
Description

Inclusion Criteria

age 60 Years to 89 Years
Description

age 60 Years to 89 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Willingness and ability to provide signed Informed Consent. In addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
Description

Willingness and ability to provide signed Informed Consent. In addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)
Description

Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)

Data type

boolean

Alias
UMLS CUI 2011AA
C1536085
MedDRA 14.1
10063947
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C0242383
SNOMED CT 2011_0131
267718000
MedDRA 14.1
10064930
ICD-9-CM Version 2011
362.50
UMLS CUI 2011AA
C0332197
SNOMED CT 2011_0131
2667000
UMLS CUI 2011AA
C0600518
Exclusion Criteria
Description

Exclusion Criteria

History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
Description

History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
C0042903
SNOMED CT 2011_0131
75732000
MedDRA 14.1
10047644
UMLS CUI 2011AA
C0542339
SNOMED CT 2011_0131
351726001, 261089000
UMLS CUI 2011AA
C0450295
SNOMED CT 2011_0131
82859000
UMLS CUI 2011AA
C1948041
SNOMED CT 2011_0131
71388002
MedDRA 14.1
10042613
LOINC Version 232
MTHU006237
ICD-9-CM Version 2011
00-99.99
UMLS CUI 2011AA
C0242383
SNOMED CT 2011_0131
267718000
MedDRA 14.1
10064930
ICD-9-CM Version 2011
362.50
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Previous subfoveal focal laser photocoagulation in the study eye
Description

Previous subfoveal focal laser photocoagulation in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0442185
SNOMED CT 2011_0131
264209008
UMLS CUI 2011AA
C0948675
MedDRA 14.1
10051532
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Laser photocoagulation in the study eye
Description

Laser photocoagulation in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0441510
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
Description

Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C0387288
SNOMED CT 2011_0131
125708009
UMLS CUI 2011AA
C1517033
UMLS CUI 2011AA
C0442379
SNOMED CT 2011_0131
260634008
UMLS CUI 2011AA
C0020548
SNOMED CT 2011_0131
261570006
MedDRA 14.1
10020846
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
GA in either eye due to causes other than AMD
Description

GA in either eye due to causes other than AMD

Data type

boolean

Alias
UMLS CUI 2011AA
C1536085
MedDRA 14.1
10063947
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
UMLS CUI 2011AA
C1518422
UMLS CUI 2011AA
C0242383
SNOMED CT 2011_0131
267718000
MedDRA 14.1
10064930
ICD-9-CM Version 2011
362.50
Diabetic retinopathy in either eye
Description

Diabetic retinopathy in either eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0011884
SNOMED CT 2011_0131
4855003
MedDRA 14.1
10012689
LOINC Version 232
MTHU020818
ICD-9-CM Version 2011
362.0
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Active or history of wet AMD in either eye
Description

Active or history of wet AMD in either eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0205381
SNOMED CT 2011_0131
17461003
UMLS CUI 2011AA
C0242383
SNOMED CT 2011_0131
267718000
MedDRA 14.1
10064930
ICD-9-CM Version 2011
362.50
UMLS CUI 2011AA
C0205447
SNOMED CT 2011_0131
38112003
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
Description

History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0012634
SNOMED CT 2011_0131
64572001
UMLS CUI 2011AA
C0025517
SNOMED CT 2011_0131
30390004
MedDRA 14.1
10058097
ICD-10-CM Version 2010
E88.9
ICD-9-CM Version 2011
277.9
UMLS CUI 2011AA
C2826636
UMLS CUI 2011AA
C0438215
SNOMED CT 2011_0131
165346000
MedDRA 14.1
10023547
UMLS CUI 2011AA
C1444657
SNOMED CT 2011_0131
410536001
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0459471
SNOMED CT 2011_0131
280452008
LOINC Version 232
MTHU003869
UMLS CUI 2011AA
C0683954
UMLS CUI 2011AA
C0332167
SNOMED CT 2011_0131
15508007
UMLS CUI 2011AA
C0679861
Active malignancy or history of malignancy within the past 5 years
Description

Active malignancy or history of malignancy within the past 5 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
C0006826
SNOMED CT 2011_0131
363346000
MedDRA 14.1
10028997
LOINC Version 232
MTHU010328
ICD-10-CM Version 2010
C00-C96
UMLS CUI 2011AA
C2735088
LOINC Version 232
MTHU034770
Previous participation in any studies of investigational drugs within 3 months preceding Day 0
Description

Previous participation in any studies of investigational drugs within 3 months preceding Day 0

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C0205449
SNOMED CT 2011_0131
421291004
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0679823
HL7 V3 2006_05
PART
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0013230
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion Criteria
age 60 Years to 89 Years
Item
age 60 Years to 89 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Willingness and ability to provide signed Informed Consent. In addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
Item
Willingness and ability to provide signed Informed Consent. In addition, at U.S. sites, Health Insurance Portability and Accountability Act (HIPAA) authorization, in other countries, as applicable according to national laws
boolean
C0021430 (UMLS CUI 2011AA)
Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)
Item
Well-demarcated area of GA secondary to age-related macular degeneration (AMD) in the absence of choroidal neovascularization (CNV)
boolean
C1536085 (UMLS CUI 2011AA)
10063947 (MedDRA 14.1)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C0242383 (UMLS CUI 2011AA)
267718000 (SNOMED CT 2011_0131)
10064930 (MedDRA 14.1)
362.50 (ICD-9-CM Version 2011)
C0332197 (UMLS CUI 2011AA)
2667000 (SNOMED CT 2011_0131)
C0600518 (UMLS CUI 2011AA)
Item Group
Exclusion Criteria
History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
Item
History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye
boolean
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
C0042903 (UMLS CUI 2011AA)
75732000 (SNOMED CT 2011_0131)
10047644 (MedDRA 14.1)
C0542339 (UMLS CUI 2011AA)
351726001, 261089000 (SNOMED CT 2011_0131)
C0450295 (UMLS CUI 2011AA)
82859000 (SNOMED CT 2011_0131)
C1948041 (UMLS CUI 2011AA)
71388002 (SNOMED CT 2011_0131)
10042613 (MedDRA 14.1)
MTHU006237 (LOINC Version 232)
00-99.99 (ICD-9-CM Version 2011)
C0242383 (UMLS CUI 2011AA)
267718000 (SNOMED CT 2011_0131)
10064930 (MedDRA 14.1)
362.50 (ICD-9-CM Version 2011)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Previous subfoveal focal laser photocoagulation in the study eye
Item
Previous subfoveal focal laser photocoagulation in the study eye
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0442185 (UMLS CUI 2011AA)
264209008 (SNOMED CT 2011_0131)
C0948675 (UMLS CUI 2011AA)
10051532 (MedDRA 14.1)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Laser photocoagulation in the study eye
Item
Laser photocoagulation in the study eye
boolean
C0441510 (UMLS CUI 2011AA)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
Item
Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
boolean
C1514463 (UMLS CUI 2011AA)
C0387288 (UMLS CUI 2011AA)
125708009 (SNOMED CT 2011_0131)
C1517033 (UMLS CUI 2011AA)
C0442379 (UMLS CUI 2011AA)
260634008 (SNOMED CT 2011_0131)
C0020548 (UMLS CUI 2011AA)
261570006 (SNOMED CT 2011_0131)
10020846 (MedDRA 14.1)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
GA in either eye due to causes other than AMD
Item
GA in either eye due to causes other than AMD
boolean
C1536085 (UMLS CUI 2011AA)
10063947 (MedDRA 14.1)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
C1518422 (UMLS CUI 2011AA)
C0242383 (UMLS CUI 2011AA)
267718000 (SNOMED CT 2011_0131)
10064930 (MedDRA 14.1)
362.50 (ICD-9-CM Version 2011)
Diabetic retinopathy in either eye
Item
Diabetic retinopathy in either eye
boolean
C0011884 (UMLS CUI 2011AA)
4855003 (SNOMED CT 2011_0131)
10012689 (MedDRA 14.1)
MTHU020818 (LOINC Version 232)
362.0 (ICD-9-CM Version 2011)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Active or history of wet AMD in either eye
Item
Active or history of wet AMD in either eye
boolean
C0205381 (UMLS CUI 2011AA)
17461003 (SNOMED CT 2011_0131)
C0242383 (UMLS CUI 2011AA)
267718000 (SNOMED CT 2011_0131)
10064930 (MedDRA 14.1)
362.50 (ICD-9-CM Version 2011)
C0205447 (UMLS CUI 2011AA)
38112003 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
Item
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0012634 (UMLS CUI 2011AA)
64572001 (SNOMED CT 2011_0131)
C0025517 (UMLS CUI 2011AA)
30390004 (SNOMED CT 2011_0131)
10058097 (MedDRA 14.1)
E88.9 (ICD-10-CM Version 2010)
277.9 (ICD-9-CM Version 2011)
C2826636 (UMLS CUI 2011AA)
C0438215 (UMLS CUI 2011AA)
165346000 (SNOMED CT 2011_0131)
10023547 (MedDRA 14.1)
C1444657 (UMLS CUI 2011AA)
410536001 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0459471 (UMLS CUI 2011AA)
280452008 (SNOMED CT 2011_0131)
MTHU003869 (LOINC Version 232)
C0683954 (UMLS CUI 2011AA)
C0332167 (UMLS CUI 2011AA)
15508007 (SNOMED CT 2011_0131)
C0679861 (UMLS CUI 2011AA)
Active malignancy or history of malignancy within the past 5 years
Item
Active malignancy or history of malignancy within the past 5 years
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
C0006826 (UMLS CUI 2011AA)
363346000 (SNOMED CT 2011_0131)
10028997 (MedDRA 14.1)
MTHU010328 (LOINC Version 232)
C00-C96 (ICD-10-CM Version 2010)
C2735088 (UMLS CUI 2011AA)
MTHU034770 (LOINC Version 232)
Previous participation in any studies of investigational drugs within 3 months preceding Day 0
Item
Previous participation in any studies of investigational drugs within 3 months preceding Day 0
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0679823 (UMLS CUI 2011AA)
PART (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
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