ID
43073
Description
ODM derived from http://clinicaltrials.gov/show/NCT01319487
Link
http://clinicaltrials.gov/show/NCT01319487
Keywords
Versions (3)
- 3/21/13 3/21/13 - Martin Dugas
- 4/19/14 4/19/14 - Julian Varghese
- 9/20/21 9/20/21 -
Uploaded on
September 20, 2021
DOI
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License
Creative Commons BY 4.0
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Eligibility NCT01319487 Diabetic Macular Edema
Eligibility
- StudyEvent: Eligibility
Description
Exclusion Criteria
Description
Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1299003
- UMLS CUI 2011AA
- C0348080
- SNOMED CT 2011_0131
- 260905004
- HL7 V3 2006_05
- COND
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
- UMLS CUI 2011AA
- C2986411
- UMLS CUI 2011AA
- C0042812
Description
Proliferative diabetic retinopathy in the study eye.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0154830
- SNOMED CT 2011_0131
- 59276001
- MedDRA 14.1
- 10036857
- ICD-9-CM Version 2011
- 362.02
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
History of panretinal scatter photocoagulation(PRP)in the study eye within 4 months prior to screening, and/or anticipated need for PRP in the 3 months following randomization.
Data type
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0679106
- UMLS CUI 2011AA
- C0686904
- SNOMED CT 2011_0131
- 103325001
- UMLS CUI 2011AA
- C0442132
- SNOMED CT 2011_0131
- 255472009
- UMLS CUI 2011AA
- C0948676
- MedDRA 14.1
- 10051530
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0474354
- SNOMED CT 2011_0131
- 247099009
- UMLS CUI 2011AA
- C0035320
- SNOMED CT 2011_0131
- 61267008
- MedDRA 14.1
- 10055666
- ICD-9-CM Version 2011
- 362.16
- UMLS CUI 2011AA
- C0154916
- SNOMED CT 2011_0131
- 51995000
- MedDRA 14.1
- 10065630
- ICD-10-CM Version 2010
- H21.1
- ICD-9-CM Version 2011
- 364.42
- UMLS CUI 2011AA
- C0600518
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
Data type
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0563537
- SNOMED CT 2011_0131
- 87021001
- MedDRA 14.1
- 10069129
- UMLS CUI 2011AA
- C0038895
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
History of use of intravitreal injectable or periocular depots corticosteroids (other than triamcinolone acetonide)within 3 months prior to the screening visit in the study eye.
Data type
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C1554888
- HL7 V3 2006_05
- IVITINJ
- UMLS CUI 2011AA
- C0230064
- UMLS CUI 2011AA
- C0086129
- UMLS CUI 2011AA
- C0001617
- SNOMED CT 2011_0131
- 79440004
- UMLS CUI 2011AA
- C0040866
- SNOMED CT 2011_0131
- 395913005
- LOINC Version 232
- MTHU018765
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
Patients who have previously received triamcinolone acetonide in the study eye:
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205156
- SNOMED CT 2011_0131
- 9130008
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C0040866
- SNOMED CT 2011_0131
- 395913005
- LOINC Version 232
- MTHU018765
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
The intended dose for each triamcinolone acetonide injection was > 4 mg.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1283828
- SNOMED CT 2011_0131
- 363703001, 363703001, 367565008
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C0040866
- SNOMED CT 2011_0131
- 395913005
- LOINC Version 232
- MTHU018765
- UMLS CUI 2011AA
- C0439093
- SNOMED CT 2011_0131
- 276140008
- HL7 V3 2006_05
- GT
- UMLS CUI 2011AA
- C0205450
- SNOMED CT 2011_0131
- 9362000
- UMLS CUI 2011AA
- C0439210
- SNOMED CT 2011_0131
- 258684004
Description
The most recent dose was < 3 months prior to the screening visit.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1513491
- HL7 V3 2006_05
- RECENT
- UMLS CUI 2011AA
- C0178602
- SNOMED CT 2011_0131
- 260911001
- UMLS CUI 2011AA
- C0040866
- SNOMED CT 2011_0131
- 395913005
- LOINC Version 232
- MTHU018765
- UMLS CUI 2011AA
- C0439092
- SNOMED CT 2011_0131
- 276139006
- HL7 V3 2006_05
- LT
- 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
- C0332152
- SNOMED CT 2011_0131
- 288556008
- UMLS CUI 2011AA
- C1409616
- UMLS CUI 2011AA
- C1512346
- HL7 V3 2006_05
- ENC
Description
Any treatment-related adverse event that was seen, and in the opinion of the investigator, has the potential to worsen or reoccur with study treatment.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0039798
- UMLS CUI 2011AA
- C0699792
- SNOMED CT 2011_0131
- 263498003
- UMLS CUI 2011AA
- C0877248
- MedDRA 14.1
- 10060933
- LOINC Version 232
- MTHU014542
- UMLS CUI 2011AA
- C0237399
- UMLS CUI 2011AA
- C0332271
- SNOMED CT 2011_0131
- 230993007
- UMLS CUI 2011AA
- C0205341
- SNOMED CT 2011_0131
- 27582007
- UMLS CUI 2011AA
- C0243132
Description
Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1514756
- UMLS CUI 2011AA
- C1514463
- UMLS CUI 2011AA
- C0521124
- SNOMED CT 2011_0131
- 65897001
- UMLS CUI 2011AA
- C1171892
- SNOMED CT 2011_0131
- 417324009
- LOINC Version 232
- MTHU016264
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0017601
- SNOMED CT 2011_0131
- 23986001
- MedDRA 14.1
- 10018304
- LOINC Version 232
- MTHU020819
- ICD-10-CM Version 2010
- H40-H42
- ICD-9-CM Version 2011
- 365
- CTCAE 1105E
- E10392
- UMLS CUI 2011AA
- C0439091
- SNOMED CT 2011_0131
- 276138003
- HL7 V3 2006_05
- GE
- UMLS CUI 2011AA
- C0205448
- SNOMED CT 2011_0131
- 19338005
- UMLS CUI 2011AA
- C0013227
Description
Aphakia or intraocular lens placement in the anterior chamber of the study eye.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0003534
- SNOMED CT 2011_0131
- 24010005
- MedDRA 14.1
- 10002945
- ICD-10-CM Version 2010
- H27.0
- ICD-9-CM Version 2011
- 379.31
- UMLS CUI 2011AA
- C1096613
- MedDRA 14.1
- 10054771
- UMLS CUI 2011AA
- C0003151
- SNOMED CT 2011_0131
- 31636006
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0015403
- SNOMED CT 2011_0131
- 128351009
- MedDRA 14.1
- 10015929
- CTCAE 1105E
- E11391
- UMLS CUI 2011AA
- C0239998
- MedDRA 14.1
- 10067860
- UMLS CUI 2011AA
- C0021376
- SNOMED CT 2011_0131
- 84499006
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
History of herpetic infection in either eye.
Data type
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0019372
- SNOMED CT 2011_0131
- 23513009
- MedDRA 14.1
- 10019973
- UMLS CUI 2011AA
- C0015392
- SNOMED CT 2011_0131
- 81745001
- LOINC Version 232
- MTHU000064
Description
History of corneal pathology/surgery
Data type
boolean
Alias
- SNOMED CT 2011_0131
- 392521001
- UMLS CUI 2011AA
- C0010034
- SNOMED CT 2011_0131
- 15250008
- MedDRA 14.1
- 10061453
- ICD-10-CM Version 2010
- H18.9
- ICD-9-CM Version 2011
- 371.9
- UMLS CUI 2011AA
- C0197402
- SNOMED CT 2011_0131
- 72208004
- MedDRA 14.1
- 10061789
- ICD-9-CM Version 2011
- 11
Description
Contact lens use at any time during the study.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1524063
- SNOMED CT 2011_0131
- 260676000
- UMLS CUI 2011AA
- C0009836
- SNOMED CT 2011_0131
- 57368009
- LOINC Version 232
- MTHU013784
- UMLS CUI 2011AA
- C0347984
- SNOMED CT 2011_0131
- 371881003
- UMLS CUI 2011AA
- C0008976
- SNOMED CT 2011_0131
- 110465008
Description
Uncontrolled systemic disease.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205318
- SNOMED CT 2011_0131
- 19032002
- UMLS CUI 2011AA
- C0442893
- SNOMED CT 2011_0131
- 56019007, 264578000
Description
Poorly controlled diabetes mellitus.
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0860161
- MedDRA 14.1
- 10012619
Description
Impaired renal function
Data type
boolean
Alias
- UMLS CUI 2011AA
- C1565489
- SNOMED CT 2011_0131
- 236423003
- MedDRA 14.1
- 10062237
Description
Poorly controlled arterial hypertension
Data type
boolean
Alias
- UMLS CUI 2011AA
- C0205169
- SNOMED CT 2011_0131
- 556001
- UMLS CUI 2011AA
- C2587213
- SNOMED CT 2011_0131
- 31509003
- UMLS CUI 2011AA
- C0020538
- SNOMED CT 2011_0131
- 38341003
- MedDRA 14.1
- 10020772
- LOINC Version 232
- MTHU020789
- ICD-10-CM Version 2010
- I10
- ICD-9-CM Version 2011
- 997.91
- CTCAE 1105E
- E13785
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- StudyEvent: Eligibility
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19338005 (SNOMED CT 2011_0131)
C0025663 (UMLS CUI 2011AA)
260686004 (SNOMED CT 2011_0131)
MTHU024654 (LOINC Version 232)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
248153007 (SNOMED CT 2011_0131)
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C0682323 (UMLS CUI 2011AA)
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C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0680240 (UMLS CUI 2011AA)
C0700589 (UMLS CUI 2011AA)
146680009 (SNOMED CT 2011_0131)
10010808 (MedDRA 14.1)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
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C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
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10065630 (MedDRA 14.1)
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364.42 (ICD-9-CM Version 2011)
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C0008976 (UMLS CUI 2011AA)
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110465008 (SNOMED CT 2011_0131)
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81745001 (SNOMED CT 2011_0131)
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19032002 (SNOMED CT 2011_0131)
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H40-H42 (ICD-10-CM Version 2010)
365 (ICD-9-CM Version 2011)
E10392 (CTCAE 1105E)
C0439091 (UMLS CUI 2011AA)
276138003 (SNOMED CT 2011_0131)
GE (HL7 V3 2006_05)
C0205448 (UMLS CUI 2011AA)
19338005 (SNOMED CT 2011_0131)
C0013227 (UMLS CUI 2011AA)
24010005 (SNOMED CT 2011_0131)
10002945 (MedDRA 14.1)
H27.0 (ICD-10-CM Version 2010)
379.31 (ICD-9-CM Version 2011)
C1096613 (UMLS CUI 2011AA)
10054771 (MedDRA 14.1)
C0003151 (UMLS CUI 2011AA)
31636006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
128351009 (SNOMED CT 2011_0131)
10015929 (MedDRA 14.1)
E11391 (CTCAE 1105E)
C0239998 (UMLS CUI 2011AA)
10067860 (MedDRA 14.1)
C0021376 (UMLS CUI 2011AA)
84499006 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C0019372 (UMLS CUI 2011AA)
23513009 (SNOMED CT 2011_0131)
10019973 (MedDRA 14.1)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C0010034 (UMLS CUI 2011AA)
15250008 (SNOMED CT 2011_0131)
10061453 (MedDRA 14.1)
H18.9 (ICD-10-CM Version 2010)
371.9 (ICD-9-CM Version 2011)
C0197402 (UMLS CUI 2011AA)
72208004 (SNOMED CT 2011_0131)
10061789 (MedDRA 14.1)
11 (ICD-9-CM Version 2011)
260676000 (SNOMED CT 2011_0131)
C0009836 (UMLS CUI 2011AA)
57368009 (SNOMED CT 2011_0131)
MTHU013784 (LOINC Version 232)
C0347984 (UMLS CUI 2011AA)
371881003 (SNOMED CT 2011_0131)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
19032002 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
10012619 (MedDRA 14.1)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
556001 (SNOMED CT 2011_0131)
C2587213 (UMLS CUI 2011AA)
31509003 (SNOMED CT 2011_0131)
C0020538 (UMLS CUI 2011AA)
38341003 (SNOMED CT 2011_0131)
10020772 (MedDRA 14.1)
MTHU020789 (LOINC Version 232)
I10 (ICD-10-CM Version 2010)
997.91 (ICD-9-CM Version 2011)
E13785 (CTCAE 1105E)