ID

43397

Description

ODM derived from http://clinicaltrials.gov/show/NCT00637377

Link

http://clinicaltrials.gov/show/NCT00637377

Keywords

Versions (4)
  1. 12/9/13 12/9/13 - Martin Dugas
  2. 4/3/14 4/3/14 - Martin Dugas
  3. 4/15/14 4/15/14 - Julian Varghese
  4. 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 NCT00637377 Macular Degeneration

German English

Eligibility

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

Inclusion Criteria

Alias
UMLS CUI 2011AA
CL425202
age at least 50 Years
Description

age at least 50 Years

Data type

boolean

Alias
UMLS CUI 2011AA
C0001779
SNOMED CT 2011_0131
397669002
Signed informed consent.
Description

Signed informed consent.

Data type

boolean

Alias
UMLS CUI 2011AA
C0021430
Men and women >/=50 years of age.
Description

Men and women >/=50 years of age.

Data type

boolean

Alias
SNOMED CT 2011_0131
339947000
SNOMED CT 2011_0131
224526002
UMLS CUI-1
C0001779
Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
Description

Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205177
SNOMED CT 2011_0131
55561003
UMLS CUI 2011AA
CL414904
UMLS CUI 2011AA
CL429630
UMLS CUI 2011AA
C0442185
SNOMED CT 2011_0131
264209008
UMLS CUI 2011AA
C0600518
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
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
C0011900
SNOMED CT 2011_0131
439401001
LOINC Version 232
MTHU008876
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C1706276
UMLS CUI 2011AA
C0450290
SNOMED CT 2011_0131
264479005
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0392760
SNOMED CT 2011_0131
247591002
UMLS CUI 2011AA
C0450290
SNOMED CT 2011_0131
264479005
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
UMLS CUI 2011AA
C0016313
SNOMED CT 2011_0131
172581008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
Description

ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.

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
C2350015
UMLS CUI 2011AA
C0449820
SNOMED CT 2011_0131
246262008
LOINC Version 232
MTHU024701
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
C0475209
SNOMED CT 2011_0131
258669008
HL7 V3 2006_05
m
Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
Description

Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.

Data type

boolean

Alias
UMLS CUI 2011AA
C0600109
SNOMED CT 2011_0131
225466006
UMLS CUI 2011AA
C0558095
SNOMED CT 2011_0131
225486005
UMLS CUI 2011AA
C0085732
SNOMED CT 2011_0131
371150009
UMLS CUI 2011AA
C0444868
SNOMED CT 2011_0131
261675009
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C1554962
HL7 V3 2006_05
C
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0445223
SNOMED CT 2011_0131
262094002
UMLS CUI 2011AA
C2700391
informed consent
Description

Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

Data type

boolean

Alias
UMLS CUI-1
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
Description

Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.

Data type

boolean

Alias
UMLS CUI 2011AA
C1299003
UMLS CUI 2011AA
C0205373
SNOMED CT 2011_0131
31099001
UMLS CUI 2011AA
C1514463
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
C0455610
SNOMED CT 2011_0131
161615003
UMLS CUI 2011AA
C0271084
SNOMED CT 2011_0131
414173003
MedDRA 14.1
10071129
ICD-10-CM Version 2010
H35.32
ICD-9-CM Version 2011
362.52
UMLS CUI 2011AA
C1554961
UMLS CUI 2011AA
C0242295
SNOMED CT 2011_0131
108961000
LOINC Version 232
MTHU035664
UMLS CUI 2011AA
C0042890
SNOMED CT 2011_0131
87708000
Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
Description

Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1707479
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C0013230
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0271084
SNOMED CT 2011_0131
414173003
MedDRA 14.1
10071129
ICD-10-CM Version 2010
H35.32
ICD-9-CM Version 2011
362.52
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Any prior treatment with anti-VEGF agents in the study eye.
Description

Any prior treatment with anti-VEGF agents in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C1514463
UMLS CUI 2011AA
CL318109
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Total lesion size >12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
Description

Total lesion size >12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C0439810
SNOMED CT 2011_0131
255619001
UMLS CUI 2011AA
C0449453
SNOMED CT 2011_0131
246116008
UMLS CUI 2011AA
C1556138
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0332257
SNOMED CT 2011_0131
55919000
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C2004491
SNOMED CT 2011_0131
12402003
ICD-10-CM Version 2010
L90.5
UMLS CUI 2011AA
C0027686
SNOMED CT 2011_0131
13018008
MedDRA 14.1
10029113
UMLS CUI 2011AA
C1516048
UMLS CUI 2011AA
C0016313
SNOMED CT 2011_0131
172581008
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
Description

Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).

Data type

boolean

Alias
UMLS CUI 2011AA
C0271049
SNOMED CT 2011_0131
13937002
MedDRA 14.1
10062981
UMLS CUI 2011AA
C0439810
SNOMED CT 2011_0131
255619001
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0005768
UMLS CUI 2011AA
C0450290
SNOMED CT 2011_0131
264479005
UMLS CUI 2011AA
C1556138
UMLS CUI 2011AA
C0205146
SNOMED CT 2011_0131
42798000
LOINC Version 232
MTHU009059
UMLS CUI 2011AA
C0456389
SNOMED CT 2011_0131
246115007
LOINC Version 232
MTHU010347
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
C0449286
SNOMED CT 2011_0131
246173007
UMLS CUI 2011AA
C0205379
SNOMED CT 2011_0131
24054004
UMLS CUI 2011AA
C0600518
Scar or fibrosis making up >50% of the total lesion in the study eye.
Description

Scar or fibrosis making up >50% of the total lesion in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C2004491
SNOMED CT 2011_0131
12402003
ICD-10-CM Version 2010
L90.5
UMLS CUI 2011AA
C0016059
SNOMED CT 2011_0131
112674009
MedDRA 14.1
10016642
UMLS CUI 2011AA
C2825407
UMLS CUI 2011AA
C0439810
SNOMED CT 2011_0131
255619001
UMLS CUI 2011AA
C0221198
SNOMED CT 2011_0131
49755003
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
Description

Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C2004491
SNOMED CT 2011_0131
12402003
ICD-10-CM Version 2010
L90.5
UMLS CUI 2011AA
C0016059
SNOMED CT 2011_0131
112674009
MedDRA 14.1
10016642
UMLS CUI 2011AA
C0333641
SNOMED CT 2011_0131
13331008
MedDRA 14.1
10003694
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0016622
SNOMED CT 2011_0131
67046006
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
Description

Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C0035322
SNOMED CT 2011_0131
41275009
UMLS CUI 2011AA
C0039409
SNOMED CT 2011_0131
40431001
LOINC Version 232
MTHU007377
UMLS CUI 2011AA
C1314939
SNOMED CT 2011_0131
248448006
UMLS CUI 2011AA
C0450295
SNOMED CT 2011_0131
82859000
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
Description

History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
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
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C1512346
HL7 V3 2006_05
ENC
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Presence of other causes of CNV in the study eye.
Description

Presence of other causes of CNV in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C0205394
SNOMED CT 2011_0131
74964007
UMLS CUI 2011AA
C1314792
SNOMED CT 2011_0131
134198009
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
Prior vitrectomy in the study eye.
Description

Prior vitrectomy in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C0332152
SNOMED CT 2011_0131
288556008
UMLS CUI 2011AA
C0042903
SNOMED CT 2011_0131
75732000
MedDRA 14.1
10047644
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
Description

History of retinal detachment or treatment or surgery for retinal detachment in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0035305
SNOMED CT 2011_0131
42059000
MedDRA 14.1
10038848
ICD-10-CM Version 2010
H33.2
ICD-9-CM Version 2011
361.9
CTCAE 1105E
E10420
UMLS CUI 2011AA
C0039798
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0035305
SNOMED CT 2011_0131
42059000
MedDRA 14.1
10038848
ICD-10-CM Version 2010
H33.2
ICD-9-CM Version 2011
361.9
CTCAE 1105E
E10420
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Any history of macular hole of stage 2 and above in the study eye.
Description

Any history of macular hole of stage 2 and above in the study eye.

Data type

boolean

Alias
UMLS CUI 2011AA
C0024441
SNOMED CT 2011_0131
232006002
MedDRA 14.1
10051058
UMLS CUI 2011AA
C0730054
SNOMED CT 2011_0131
312702001
UMLS CUI 2011AA
C0730055
SNOMED CT 2011_0131
312703006
UMLS CUI 2011AA
C0730056
SNOMED CT 2011_0131
312704000
UMLS CUI 2011AA
C0008976
SNOMED CT 2011_0131
110465008
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
Description

Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.

Data type

boolean

Alias
UMLS CUI 2011AA
CL429484
UMLS CUI 2011AA
C0230064
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C2825406
UMLS CUI 2011AA
C0439234
SNOMED CT 2011_0131
258707000
HL7 V3 2006_05
Y
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
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
C1554961
HL7 V3 2006_05
E
UMLS CUI 2011AA
C0015426
SNOMED CT 2011_0131
80243003
UMLS CUI 2011AA
C0038895
UMLS CUI 2011AA
C0439231
SNOMED CT 2011_0131
258706009
HL7 V3 2006_05
MO
UMLS CUI 2011AA
C0439228
SNOMED CT 2011_0131
258703001
HL7 V3 2006_05
D
UMLS CUI 2011AA
C0750558
UMLS CUI 2011AA
C0521102
SNOMED CT 2011_0131
78235001
UMLS CUI 2011AA
C1533685
SNOMED CT 2011_0131
59108006
MedDRA 14.1
10052995
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
Description

History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.

Data type

boolean

Alias
UMLS CUI 2011AA
CL421546
SNOMED CT 2011_0131
392521001
UMLS CUI 2011AA
C0205210
SNOMED CT 2011_0131
58147004
UMLS CUI 2011AA
C0332120
SNOMED CT 2011_0131
18669006
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
C0241863
MedDRA 14.1
10012641
UMLS CUI 2011AA
C0271051
SNOMED CT 2011_0131
37231002
MedDRA 14.1
10025415
UMLS CUI 2011AA
C0154833
SNOMED CT 2011_0131
57534004
MedDRA 14.1
10038901
CTCAE 1105E
E10429
UMLS CUI 2011AA
CL411789
UMLS CUI 2011AA
C0242383
SNOMED CT 2011_0131
267718000
MedDRA 14.1
10064930
ICD-9-CM Version 2011
362.50
UMLS CUI 2011AA
C0015392
SNOMED CT 2011_0131
81745001
LOINC Version 232
MTHU000064
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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 50 Years
Item
age at least 50 Years
boolean
C0001779 (UMLS CUI 2011AA)
397669002 (SNOMED CT 2011_0131)
Signed informed consent.
Item
Signed informed consent.
boolean
C0021430 (UMLS CUI 2011AA)
Men and women >/=50 years of age
Item
Men and women >/=50 years of age.
boolean
339947000 (SNOMED CT 2011_0131)
224526002 (SNOMED CT 2011_0131)
C0001779 (UMLS CUI-1)
Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
Item
Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
boolean
C0205177 (UMLS CUI 2011AA)
55561003 (SNOMED CT 2011_0131)
CL414904 (UMLS CUI 2011AA)
CL429630 (UMLS CUI 2011AA)
C0442185 (UMLS CUI 2011AA)
264209008 (SNOMED CT 2011_0131)
C0600518 (UMLS CUI 2011AA)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
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)
C0011900 (UMLS CUI 2011AA)
439401001 (SNOMED CT 2011_0131)
MTHU008876 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C1706276 (UMLS CUI 2011AA)
C0450290 (UMLS CUI 2011AA)
264479005 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0392760 (UMLS CUI 2011AA)
247591002 (SNOMED CT 2011_0131)
C0450290 (UMLS CUI 2011AA)
264479005 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0016313 (UMLS CUI 2011AA)
172581008 (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)
ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
Item
ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
boolean
C1275992 (UMLS CUI 2011AA)
400914004 (SNOMED CT 2011_0131)
C1690532 (UMLS CUI 2011AA)
419775003 (SNOMED CT 2011_0131)
C2350015 (UMLS CUI 2011AA)
C0449820 (UMLS CUI 2011AA)
246262008 (SNOMED CT 2011_0131)
MTHU024701 (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)
C0475209 (UMLS CUI 2011AA)
258669008 (SNOMED CT 2011_0131)
m (HL7 V3 2006_05)
Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
Item
Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
boolean
C0600109 (UMLS CUI 2011AA)
225466006 (SNOMED CT 2011_0131)
C0558095 (UMLS CUI 2011AA)
225486005 (SNOMED CT 2011_0131)
C0085732 (UMLS CUI 2011AA)
371150009 (SNOMED CT 2011_0131)
C0444868 (UMLS CUI 2011AA)
261675009 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (HL7 V3 2006_05)
C1554962 (UMLS CUI 2011AA)
C (HL7 V3 2006_05)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0445223 (UMLS CUI 2011AA)
262094002 (SNOMED CT 2011_0131)
C2700391 (UMLS CUI 2011AA)
informed consent
Item
informed consent
boolean
C0021430 (UMLS CUI-1)
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
Item
Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
boolean
C1299003 (UMLS CUI 2011AA)
C0205373 (UMLS CUI 2011AA)
31099001 (SNOMED CT 2011_0131)
C1514463 (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)
C0455610 (UMLS CUI 2011AA)
161615003 (SNOMED CT 2011_0131)
C0271084 (UMLS CUI 2011AA)
414173003 (SNOMED CT 2011_0131)
10071129 (MedDRA 14.1)
H35.32 (ICD-10-CM Version 2010)
362.52 (ICD-9-CM Version 2011)
C1554961 (UMLS CUI 2011AA)
C0242295 (UMLS CUI 2011AA)
108961000 (SNOMED CT 2011_0131)
MTHU035664 (LOINC Version 232)
C0042890 (UMLS CUI 2011AA)
87708000 (SNOMED CT 2011_0131)
Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
Item
Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1707479 (UMLS CUI 2011AA)
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C0013230 (UMLS CUI 2011AA)
C0039798 (UMLS CUI 2011AA)
C0271084 (UMLS CUI 2011AA)
414173003 (SNOMED CT 2011_0131)
10071129 (MedDRA 14.1)
H35.32 (ICD-10-CM Version 2010)
362.52 (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)
Any prior treatment with anti-VEGF agents in the study eye.
Item
Any prior treatment with anti-VEGF agents in the study eye.
boolean
C1514463 (UMLS CUI 2011AA)
CL318109 (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)
Total lesion size >12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
Item
Total lesion size >12 disc areas (30.5 mm, including blood, scars and neovascularization) as assessed by FA in the study eye.
boolean
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
C0449453 (UMLS CUI 2011AA)
246116008 (SNOMED CT 2011_0131)
C1556138 (UMLS CUI 2011AA)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0332257 (UMLS CUI 2011AA)
55919000 (SNOMED CT 2011_0131)
C0005768 (UMLS CUI 2011AA)
C2004491 (UMLS CUI 2011AA)
12402003 (SNOMED CT 2011_0131)
L90.5 (ICD-10-CM Version 2010)
C0027686 (UMLS CUI 2011AA)
13018008 (SNOMED CT 2011_0131)
10029113 (MedDRA 14.1)
C1516048 (UMLS CUI 2011AA)
C0016313 (UMLS CUI 2011AA)
172581008 (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)
Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
Item
Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV).
boolean
C0271049 (UMLS CUI 2011AA)
13937002 (SNOMED CT 2011_0131)
10062981 (MedDRA 14.1)
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (SNOMED CT 2011_0131)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0005768 (UMLS CUI 2011AA)
C0450290 (UMLS CUI 2011AA)
264479005 (SNOMED CT 2011_0131)
C1556138 (UMLS CUI 2011AA)
C0205146 (UMLS CUI 2011AA)
42798000 (SNOMED CT 2011_0131)
MTHU009059 (LOINC Version 232)
C0456389 (UMLS CUI 2011AA)
246115007 (SNOMED CT 2011_0131)
MTHU010347 (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)
C0449286 (UMLS CUI 2011AA)
246173007 (SNOMED CT 2011_0131)
C0205379 (UMLS CUI 2011AA)
24054004 (SNOMED CT 2011_0131)
C0600518 (UMLS CUI 2011AA)
Scar or fibrosis making up >50% of the total lesion in the study eye.
Item
Scar or fibrosis making up >50% of the total lesion in the study eye.
boolean
C2004491 (UMLS CUI 2011AA)
12402003 (SNOMED CT 2011_0131)
L90.5 (ICD-10-CM Version 2010)
C0016059 (UMLS CUI 2011AA)
112674009 (SNOMED CT 2011_0131)
10016642 (MedDRA 14.1)
C2825407 (UMLS CUI 2011AA)
C0439810 (UMLS CUI 2011AA)
255619001 (SNOMED CT 2011_0131)
C0221198 (UMLS CUI 2011AA)
49755003 (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)
Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
Item
Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
boolean
C2004491 (UMLS CUI 2011AA)
12402003 (SNOMED CT 2011_0131)
L90.5 (ICD-10-CM Version 2010)
C0016059 (UMLS CUI 2011AA)
112674009 (SNOMED CT 2011_0131)
10016642 (MedDRA 14.1)
C0333641 (UMLS CUI 2011AA)
13331008 (SNOMED CT 2011_0131)
10003694 (MedDRA 14.1)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0016622 (UMLS CUI 2011AA)
67046006 (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)
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
Item
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye.
boolean
C0035322 (UMLS CUI 2011AA)
41275009 (SNOMED CT 2011_0131)
C0039409 (UMLS CUI 2011AA)
40431001 (SNOMED CT 2011_0131)
MTHU007377 (LOINC Version 232)
C1314939 (UMLS CUI 2011AA)
248448006 (SNOMED CT 2011_0131)
C0450295 (UMLS CUI 2011AA)
82859000 (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 any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
Item
History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
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)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C1512346 (UMLS CUI 2011AA)
ENC (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)
Presence of other causes of CNV in the study eye.
Item
Presence of other causes of CNV in the study eye.
boolean
C0205394 (UMLS CUI 2011AA)
74964007 (SNOMED CT 2011_0131)
C1314792 (UMLS CUI 2011AA)
134198009 (SNOMED CT 2011_0131)
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)
Prior vitrectomy in the study eye.
Item
Prior vitrectomy in the study eye.
boolean
C0332152 (UMLS CUI 2011AA)
288556008 (SNOMED CT 2011_0131)
C0042903 (UMLS CUI 2011AA)
75732000 (SNOMED CT 2011_0131)
10047644 (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)
History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
Item
History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0035305 (UMLS CUI 2011AA)
42059000 (SNOMED CT 2011_0131)
10038848 (MedDRA 14.1)
H33.2 (ICD-10-CM Version 2010)
361.9 (ICD-9-CM Version 2011)
E10420 (CTCAE 1105E)
C0039798 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C0035305 (UMLS CUI 2011AA)
42059000 (SNOMED CT 2011_0131)
10038848 (MedDRA 14.1)
H33.2 (ICD-10-CM Version 2010)
361.9 (ICD-9-CM Version 2011)
E10420 (CTCAE 1105E)
C0008976 (UMLS CUI 2011AA)
110465008 (SNOMED CT 2011_0131)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
Any history of macular hole of stage 2 and above in the study eye.
Item
Any history of macular hole of stage 2 and above in the study eye.
boolean
C0024441 (UMLS CUI 2011AA)
232006002 (SNOMED CT 2011_0131)
10051058 (MedDRA 14.1)
C0730054 (UMLS CUI 2011AA)
312702001 (SNOMED CT 2011_0131)
C0730055 (UMLS CUI 2011AA)
312703006 (SNOMED CT 2011_0131)
C0730056 (UMLS CUI 2011AA)
312704000 (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 intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
Item
Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection.
boolean
CL429484 (UMLS CUI 2011AA)
C0230064 (UMLS CUI 2011AA)
C0038895 (UMLS CUI 2011AA)
C2825406 (UMLS CUI 2011AA)
C0439234 (UMLS CUI 2011AA)
258707000 (SNOMED CT 2011_0131)
Y (HL7 V3 2006_05)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (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)
C1554961 (UMLS CUI 2011AA)
E (HL7 V3 2006_05)
C0015426 (UMLS CUI 2011AA)
80243003 (SNOMED CT 2011_0131)
C0038895 (UMLS CUI 2011AA)
C0439231 (UMLS CUI 2011AA)
258706009 (SNOMED CT 2011_0131)
MO (HL7 V3 2006_05)
C0439228 (UMLS CUI 2011AA)
258703001 (SNOMED CT 2011_0131)
D (HL7 V3 2006_05)
C0750558 (UMLS CUI 2011AA)
C0521102 (UMLS CUI 2011AA)
78235001 (SNOMED CT 2011_0131)
C1533685 (UMLS CUI 2011AA)
59108006 (SNOMED CT 2011_0131)
10052995 (MedDRA 14.1)
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
Item
History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye.
boolean
CL421546 (UMLS CUI 2011AA)
392521001 (SNOMED CT 2011_0131)
C0205210 (UMLS CUI 2011AA)
58147004 (SNOMED CT 2011_0131)
C0332120 (UMLS CUI 2011AA)
18669006 (SNOMED CT 2011_0131)
C0011884 (UMLS CUI 2011AA)
4855003 (SNOMED CT 2011_0131)
10012689 (MedDRA 14.1)
MTHU020818 (LOINC Version 232)
362.0 (ICD-9-CM Version 2011)
C0241863 (UMLS CUI 2011AA)
10012641 (MedDRA 14.1)
C0271051 (UMLS CUI 2011AA)
37231002 (SNOMED CT 2011_0131)
10025415 (MedDRA 14.1)
C0154833 (UMLS CUI 2011AA)
57534004 (SNOMED CT 2011_0131)
10038901 (MedDRA 14.1)
E10429 (CTCAE 1105E)
CL411789 (UMLS CUI 2011AA)
C0242383 (UMLS CUI 2011AA)
267718000 (SNOMED CT 2011_0131)
10064930 (MedDRA 14.1)
362.50 (ICD-9-CM Version 2011)
C0015392 (UMLS CUI 2011AA)
81745001 (SNOMED CT 2011_0131)
MTHU000064 (LOINC Version 232)
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