ID

43073

Description

ODM derived from http://clinicaltrials.gov/show/NCT01319487

Link

http://clinicaltrials.gov/show/NCT01319487

Keywords

Versions (3)
  1. 3/21/13 3/21/13 - Martin Dugas
  2. 4/19/14 4/19/14 - Julian Varghese
  3. 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

German English

Eligibility

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

Inclusion Criteria

age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Diagnosis of diabetes mellitus
Description

Diagnosis of diabetes mellitus

Data type

boolean

Alias
UMLS CUI 1
C0011900
UMLS CUI 1*1
C0011849
LOINC Version 232
MTHU008876
Patient must be able to self administer study drug.
Description

Patient must be able to self administer study drug.

Data type

boolean

Alias
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0036589
SNOMED CT 2011_0131
225425006
UMLS CUI 2011AA
C0304229
SNOMED CT 2011_0131
902003
Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:
Description

Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:

Data type

boolean

Alias
UMLS CUI 2011AA
C0730284
SNOMED CT 2011_0131
312911008
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
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
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0016622
SNOMED CT 2011_0131
67046006
Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).
Description

Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).

Data type

boolean

Alias
UMLS CUI 2011AA
C2945599
SNOMED CT 2011_0131
255604002
UMLS CUI 2011AA
C0205082
SNOMED CT 2011_0131
24484000
UMLS CUI 2011AA
C0154830
SNOMED CT 2011_0131
59276001
MedDRA 14.1
10036857
ICD-9-CM Version 2011
362.02
UMLS CUI 2011AA
C1275992
SNOMED CT 2011_0131
400914004
UMLS CUI 2011AA
C0441800
SNOMED CT 2011_0131
258349007
LOINC Version 232
MTHU003112
BCVA score ≥ 34 letters and < 80 letters in the study eye.
Description

BCVA score ≥ 34 letters and < 80 letters in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C1690532
SNOMED CT 2011_0131
419775003
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
UMLS CUI 2011AA
C3174570
LOINC Version 232
MTHU038801
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study.
Description

Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0043210
SNOMED CT 2011_0131
224526002
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0027552
SNOMED CT 2011_0131
410525008
UMLS CUI 2011AA
C0430057
SNOMED CT 2011_0131
167254001
MedDRA 14.1
10036577
UMLS CUI 2011AA
C0205448
SNOMED CT 2011_0131
19338005
UMLS CUI 2011AA
C0025663
SNOMED CT 2011_0131
260686004
LOINC Version 232
MTHU024654
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.
Description

Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.

Data type

boolean

Alias
UMLS CUI 2011AA
C0086582
SNOMED CT 2011_0131
248153007
HL7 V3 2006_05
M
UMLS CUI 2011AA
C0682323
SNOMED CT 2011_0131
262043009
HL7 V3 2006_05
SIGOTHR
UMLS CUI 2011AA
C1148523
UMLS CUI 2011AA
C0237399
UMLS CUI 2011AA
C0680240
UMLS CUI 2011AA
C0700589
SNOMED CT 2011_0131
146680009
MedDRA 14.1
10010808
Exclusion Criteria
Description

Exclusion Criteria

Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
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
Proliferative diabetic retinopathy in the study eye.
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
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.
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
Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
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
History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
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
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.
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
Patients who have previously received triamcinolone acetonide in the study eye:
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
The intended dose for each triamcinolone acetonide injection was > 4 mg.
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
The most recent dose was < 3 months prior to the screening visit.
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
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.
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
Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
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
Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
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
Aphakia or intraocular lens placement in the anterior chamber of the study eye.
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
Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
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
History of herpetic infection in either eye.
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
History of corneal pathology/surgery
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
Contact lens use at any time during the study.
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
Uncontrolled systemic disease.
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
Diabetes mellitus poor control
Description

Poorly controlled diabetes mellitus.

Data type

boolean

Alias
UMLS CUI 2011AA
C0860161
MedDRA 14.1
10012619
Impaired renal function
Description

Impaired renal function

Data type

boolean

Alias
UMLS CUI 2011AA
C1565489
SNOMED CT 2011_0131
236423003
MedDRA 14.1
10062237
Poorly controlled arterial hypertension
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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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 at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Diagnosis of diabetes mellitus
Item
Diagnosis of diabetes mellitus
boolean
C0011900 (UMLS CUI 1)
C0011849 (UMLS CUI 1*1)
MTHU008876 (LOINC Version 232)
Patient must be able to self administer study drug.
Item
Patient must be able to self administer study drug.
boolean
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0036589 (UMLS CUI 2011AA)
225425006 (SNOMED CT 2011_0131)
C0304229 (UMLS CUI 2011AA)
902003 (SNOMED CT 2011_0131)
Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:
Item
Clinically significant diabetic macular edema in at least one eye ("study eye") involving the center of the macula:
boolean
C0730284 (UMLS CUI 2011AA)
312911008 (SNOMED CT 2011_0131)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0016622 (UMLS CUI 2011AA)
67046006 (SNOMED CT 2011_0131)
Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).
Item
Mild to severe non proliferative diabetic retinopathy (Early Treatment Diabetic Retinopathy Study [ETDRS] grade between 20 and 53).
boolean
C2945599 (UMLS CUI 2011AA)
255604002 (SNOMED CT 2011_0131)
C0205082 (UMLS CUI 2011AA)
24484000 (SNOMED CT 2011_0131)
C0154830 (UMLS CUI 2011AA)
59276001 (SNOMED CT 2011_0131)
10036857 (MedDRA 14.1)
362.02 (ICD-9-CM Version 2011)
C1275992 (UMLS CUI 2011AA)
400914004 (SNOMED CT 2011_0131)
C0441800 (UMLS CUI 2011AA)
258349007 (SNOMED CT 2011_0131)
MTHU003112 (LOINC Version 232)
BCVA score ≥ 34 letters and < 80 letters in the study eye.
Item
BCVA score ≥ 34 letters and < 80 letters in the study eye.
boolean
C1690532 (UMLS CUI 2011AA)
419775003 (SNOMED CT 2011_0131)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (LOINC Version 232)
C3174570 (UMLS CUI 2011AA)
MTHU038801 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study.
Item
Women of childbearing potential must have a negative urine pregnancy test at Screening and be using two highly effective methods of contraception throughout the study.
boolean
C0043210 (UMLS CUI 2011AA)
224526002 (SNOMED CT 2011_0131)
C1148523 (UMLS CUI 2011AA)
C0237399 (UMLS CUI 2011AA)
C0027552 (UMLS CUI 2011AA)
410525008 (SNOMED CT 2011_0131)
C0430057 (UMLS CUI 2011AA)
167254001 (SNOMED CT 2011_0131)
10036577 (MedDRA 14.1)
C0205448 (UMLS CUI 2011AA)
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)
Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.
Item
Male patients with partners of childbearing potential must agree to use at least one highly effective method of contraception throughout the study.
boolean
C0086582 (UMLS CUI 2011AA)
248153007 (SNOMED CT 2011_0131)
M (HL7 V3 2006_05)
C0682323 (UMLS CUI 2011AA)
262043009 (SNOMED CT 2011_0131)
SIGOTHR (HL7 V3 2006_05)
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)
Item Group
Exclusion Criteria
Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
Item
Any ocular condition in the study eye that in the opinion of the investigator would prevent improvement in visual acuity.
boolean
C1299003 (UMLS CUI 2011AA)
C0348080 (UMLS CUI 2011AA)
260905004 (SNOMED CT 2011_0131)
COND (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
C2986411 (UMLS CUI 2011AA)
C0042812 (UMLS CUI 2011AA)
Proliferative diabetic retinopathy in the study eye.
Item
Proliferative diabetic retinopathy in the study eye.
boolean
C0154830 (UMLS CUI 2011AA)
59276001 (SNOMED CT 2011_0131)
10036857 (MedDRA 14.1)
362.02 (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)
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.
Item
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.
boolean
392521001 (SNOMED CT 2011_0131)
C0679106 (UMLS CUI 2011AA)
C0686904 (UMLS CUI 2011AA)
103325001 (SNOMED CT 2011_0131)
C0442132 (UMLS CUI 2011AA)
255472009 (SNOMED CT 2011_0131)
C0948676 (UMLS CUI 2011AA)
10051530 (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)
Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
Item
Active optic disc or retinal neovascularization, rubeosis iridis, active or history of choroidal neovascularization in the study eye.
boolean
C0474354 (UMLS CUI 2011AA)
247099009 (SNOMED CT 2011_0131)
C0035320 (UMLS CUI 2011AA)
61267008 (SNOMED CT 2011_0131)
10055666 (MedDRA 14.1)
362.16 (ICD-9-CM Version 2011)
C0154916 (UMLS CUI 2011AA)
51995000 (SNOMED CT 2011_0131)
10065630 (MedDRA 14.1)
H21.1 (ICD-10-CM Version 2010)
364.42 (ICD-9-CM Version 2011)
C0600518 (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)
History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
Item
History of pars plana vitrectomy at any time, intraocular surgery in the study eye within 90 days prior to screening.
boolean
392521001 (SNOMED CT 2011_0131)
C0563537 (UMLS CUI 2011AA)
87021001 (SNOMED CT 2011_0131)
10069129 (MedDRA 14.1)
C0038895 (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)
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.
Item
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.
boolean
392521001 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
C1554888 (UMLS CUI 2011AA)
IVITINJ (HL7 V3 2006_05)
C0230064 (UMLS CUI 2011AA)
C0086129 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (SNOMED CT 2011_0131)
C0040866 (UMLS CUI 2011AA)
395913005 (SNOMED CT 2011_0131)
MTHU018765 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Patients who have previously received triamcinolone acetonide in the study eye:
Item
Patients who have previously received triamcinolone acetonide in the study eye:
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1514756 (UMLS CUI 2011AA)
C0040866 (UMLS CUI 2011AA)
395913005 (SNOMED CT 2011_0131)
MTHU018765 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
The intended dose for each triamcinolone acetonide injection was > 4 mg.
Item
The intended dose for each triamcinolone acetonide injection was > 4 mg.
boolean
C1283828 (UMLS CUI 2011AA)
363703001, 363703001, 367565008 (SNOMED CT 2011_0131)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0040866 (UMLS CUI 2011AA)
395913005 (SNOMED CT 2011_0131)
MTHU018765 (LOINC Version 232)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205450 (UMLS CUI 2011AA)
9362000 (SNOMED CT 2011_0131)
C0439210 (UMLS CUI 2011AA)
258684004 (SNOMED CT 2011_0131)
The most recent dose was < 3 months prior to the screening visit.
Item
The most recent dose was < 3 months prior to the screening visit.
boolean
C1513491 (UMLS CUI 2011AA)
RECENT (HL7 V3 2006_05)
C0178602 (UMLS CUI 2011AA)
260911001 (SNOMED CT 2011_0131)
C0040866 (UMLS CUI 2011AA)
395913005 (SNOMED CT 2011_0131)
MTHU018765 (LOINC Version 232)
C0439092 (UMLS CUI 2011AA)
276139006 (SNOMED CT 2011_0131)
LT (HL7 V3 2006_05)
C0205449 (UMLS CUI 2011AA)
421291004 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1409616 (UMLS CUI 2011AA)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
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.
Item
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.
boolean
C0039798 (UMLS CUI 2011AA)
C0699792 (UMLS CUI 2011AA)
263498003 (SNOMED CT 2011_0131)
C0877248 (UMLS CUI 2011AA)
10060933 (MedDRA 14.1)
MTHU014542 (LOINC Version 232)
C0237399 (UMLS CUI 2011AA)
C0332271 (UMLS CUI 2011AA)
230993007 (SNOMED CT 2011_0131)
C0205341 (UMLS CUI 2011AA)
27582007 (SNOMED CT 2011_0131)
C0243132 (UMLS CUI 2011AA)
Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
Item
Patients who have previously received anti-VEGF therapy within 3 months prior to the screening visit in the study eye.
boolean
C1514756 (UMLS CUI 2011AA)
C1514463 (UMLS CUI 2011AA)
C0521124 (UMLS CUI 2011AA)
65897001 (SNOMED CT 2011_0131)
C1171892 (UMLS CUI 2011AA)
417324009 (SNOMED CT 2011_0131)
MTHU016264 (LOINC Version 232)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
Item
Uncontrolled glaucoma or glaucoma treated by 2 or more medications.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0017601 (UMLS CUI 2011AA)
23986001 (SNOMED CT 2011_0131)
10018304 (MedDRA 14.1)
MTHU020819 (LOINC Version 232)
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)
Aphakia or intraocular lens placement in the anterior chamber of the study eye.
Item
Aphakia or intraocular lens placement in the anterior chamber of the study eye.
boolean
C0003534 (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)
Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
Item
Any active ocular infection; any history of recurrent or chronic infection or inflammation in the study eye.
boolean
C0015403 (UMLS CUI 2011AA)
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)
History of herpetic infection in either eye.
Item
History of herpetic infection in either eye.
boolean
392521001 (SNOMED CT 2011_0131)
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)
History of corneal pathology/surgery
Item
History of corneal pathology/surgery
boolean
392521001 (SNOMED CT 2011_0131)
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)
Contact lens use at any time during the study.
Item
Contact lens use at any time during the study.
boolean
C1524063 (UMLS CUI 2011AA)
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)
Uncontrolled systemic disease.
Item
Uncontrolled systemic disease.
boolean
C0205318 (UMLS CUI 2011AA)
19032002 (SNOMED CT 2011_0131)
C0442893 (UMLS CUI 2011AA)
56019007, 264578000 (SNOMED CT 2011_0131)
Poorly controlled diabetes mellitus.
Item
Diabetes mellitus poor control
boolean
C0860161 (UMLS CUI 2011AA)
10012619 (MedDRA 14.1)
Impaired renal function
Item
Impaired renal function
boolean
C1565489 (UMLS CUI 2011AA)
236423003 (SNOMED CT 2011_0131)
10062237 (MedDRA 14.1)
Poorly controlled arterial hypertension
Item
Poorly controlled arterial hypertension
boolean
C0205169 (UMLS CUI 2011AA)
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)
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