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)
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)