ID

4347

Description

ODM derived from http://clinicaltrials.gov/show/NCT01012973

Link

http://clinicaltrials.gov/show/NCT01012973

Keywords

Versions (2)
  1. 12/7/13 12/7/13 - Martin Dugas
  2. 9/17/21 9/17/21 -
Uploaded on

December 7, 2013

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT01012973 Retinal Vein Occlusion

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 18 Years
Description

age at least 18 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness >= 250 microm on optical coherence tomography (OCT)
Description

Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness >= 250 microm on optical coherence tomography (OCT)

Data type

boolean

Alias
UMLS CUI 2011AA
C0205099
SNOMED CT 2011_0131
26216008
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0271051
SNOMED CT 2011_0131
37231002
MedDRA 14.1
10025415
UMLS CUI 2011AA
C0175668
SNOMED CT 2011_0131
2603003
UMLS CUI 2011AA
C0154841
SNOMED CT 2011_0131
68478007
MedDRA 14.1
10007972
ICD-10-CM Version 2010
H34.81
ICD-9-CM Version 2011
362.35
UMLS CUI 2011AA
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0920367
SNOMED CT 2011_0131
392010000
MedDRA 14.1
10057208
Adult (person)
Description

Adults >= 18 years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001675
SNOMED CT 2011_0131
133936004
Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye
Description

Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C1275992
SNOMED CT 2011_0131
400914004
UMLS CUI 2011AA
C1690532
SNOMED CT 2011_0131
419775003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI 2011AA
CL425201
Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
Description

Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
C1254351
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
UMLS CUI 2011AA
C0967532
SNOMED CT 2011_0131
423490007
UMLS CUI 2011AA
C0963154
UMLS CUI 2011AA
C0796392
SNOMED CT 2011_0131
409406007
UMLS CUI 2011AA
C1566537
SNOMED CT 2011_0131
425256004
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C0596087
SNOMED CT 2011_0131
409407003
Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
Description

Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0730064
SNOMED CT 2011_0131
312713003
MedDRA 14.1
10051531
UMLS CUI 2011AA
C0450295
SNOMED CT 2011_0131
82859000
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
CRVO disease duration > 9 months from date of diagnosis
Description

CRVO disease duration > 9 months from date of diagnosis

Data type

boolean

Alias
UMLS CUI 2011AA
C0154841
SNOMED CT 2011_0131
68478007
MedDRA 14.1
10007972
ICD-10-CM Version 2010
H34.81
ICD-9-CM Version 2011
362.35
UMLS CUI 2011AA
C0872146
UMLS CUI 2011AA
C0439093
SNOMED CT 2011_0131
276140008
HL7 V3 2006_05
GT
UMLS CUI 2011AA
C0205455
SNOMED CT 2011_0131
422113007, 36987007
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C2316983
SNOMED CT 2011_0131
432213005
Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
Description

Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1

Data type

boolean

Alias
UMLS CUI 2011AA
C0205156
SNOMED CT 2011_0131
9130008
UMLS CUI 2011AA
C1524063
SNOMED CT 2011_0131
260676000
UMLS CUI 2011AA
CL429484
UMLS CUI 2011AA
C1882336
UMLS CUI 2011AA
C0001617
SNOMED CT 2011_0131
79440004
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
Description

Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Data type

boolean

Alias
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
C0042909
SNOMED CT 2011_0131
31341008
MedDRA 14.1
10047655
ICD-10-CM Version 2010
H43.1
ICD-9-CM Version 2011
379.23
CTCAE 1105E
E10447
UMLS CUI 2011AA
C0154828
SNOMED CT 2011_0131
34711008
MedDRA 14.1
10044331
ICD-10-CM Version 2010
H33.40
ICD-9-CM Version 2011
361.81
UMLS CUI 2011AA
C0154853
SNOMED CT 2011_0131
367649002
MedDRA 14.1
10063738
ICD-9-CM Version 2011
362.56
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0450295
SNOMED CT 2011_0131
82859000
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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
CL425202 (UMLS CUI 2011AA)
age at least 18 Years
Item
age at least 18 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness >= 250 microm on optical coherence tomography (OCT)
Item
Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness >= 250 microm on optical coherence tomography (OCT)
boolean
C0205099 (UMLS CUI 2011AA)
26216008 (SNOMED CT 2011_0131)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0271051 (UMLS CUI 2011AA)
37231002 (SNOMED CT 2011_0131)
10025415 (MedDRA 14.1)
C0175668 (UMLS CUI 2011AA)
2603003 (SNOMED CT 2011_0131)
C0154841 (UMLS CUI 2011AA)
68478007 (SNOMED CT 2011_0131)
10007972 (MedDRA 14.1)
H34.81 (ICD-10-CM Version 2010)
362.35 (ICD-9-CM Version 2011)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0920367 (UMLS CUI 2011AA)
392010000 (SNOMED CT 2011_0131)
10057208 (MedDRA 14.1)
Adults >= 18 years
Item
Adult (person)
boolean
C0001675 (UMLS CUI 2011AA)
133936004 (SNOMED CT 2011_0131)
Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye
Item
Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye
boolean
C1275992 (UMLS CUI 2011AA)
400914004 (SNOMED CT 2011_0131)
C1690532 (UMLS CUI 2011AA)
419775003 (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)
Item Group
Exclusion Criteria
CL425201 (UMLS CUI 2011AA)
Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
Item
Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
boolean
C1514463 (UMLS CUI 2011AA)
C1254351 (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)
C0967532 (UMLS CUI 2011AA)
423490007 (SNOMED CT 2011_0131)
C0963154 (UMLS CUI 2011AA)
C0796392 (UMLS CUI 2011AA)
409406007 (SNOMED CT 2011_0131)
C1566537 (UMLS CUI 2011AA)
425256004 (SNOMED CT 2011_0131)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C0596087 (UMLS CUI 2011AA)
409407003 (SNOMED CT 2011_0131)
Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
Item
Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0730064 (UMLS CUI 2011AA)
312713003 (SNOMED CT 2011_0131)
10051531 (MedDRA 14.1)
C0450295 (UMLS CUI 2011AA)
82859000 (SNOMED CT 2011_0131)
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)
CRVO disease duration > 9 months from date of diagnosis
Item
CRVO disease duration > 9 months from date of diagnosis
boolean
C0154841 (UMLS CUI 2011AA)
68478007 (SNOMED CT 2011_0131)
10007972 (MedDRA 14.1)
H34.81 (ICD-10-CM Version 2010)
362.35 (ICD-9-CM Version 2011)
C0872146 (UMLS CUI 2011AA)
C0439093 (UMLS CUI 2011AA)
276140008 (SNOMED CT 2011_0131)
GT (HL7 V3 2006_05)
C0205455 (UMLS CUI 2011AA)
422113007, 36987007 (SNOMED CT 2011_0131)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C2316983 (UMLS CUI 2011AA)
432213005 (SNOMED CT 2011_0131)
Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
Item
Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
boolean
C0205156 (UMLS CUI 2011AA)
9130008 (SNOMED CT 2011_0131)
C1524063 (UMLS CUI 2011AA)
260676000 (SNOMED CT 2011_0131)
CL429484 (UMLS CUI 2011AA)
C1882336 (UMLS CUI 2011AA)
C0001617 (UMLS CUI 2011AA)
79440004 (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)
Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
Item
Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye
boolean
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)
C0042909 (UMLS CUI 2011AA)
31341008 (SNOMED CT 2011_0131)
10047655 (MedDRA 14.1)
H43.1 (ICD-10-CM Version 2010)
379.23 (ICD-9-CM Version 2011)
E10447 (CTCAE 1105E)
C0154828 (UMLS CUI 2011AA)
34711008 (SNOMED CT 2011_0131)
10044331 (MedDRA 14.1)
H33.40 (ICD-10-CM Version 2010)
361.81 (ICD-9-CM Version 2011)
C0154853 (UMLS CUI 2011AA)
367649002 (SNOMED CT 2011_0131)
10063738 (MedDRA 14.1)
362.56 (ICD-9-CM Version 2011)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0450295 (UMLS CUI 2011AA)
82859000 (SNOMED CT 2011_0131)
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