Eligibility

  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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