Eligibility NCT00133952 # Diabetes Mellitus

The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
Healthy Volunteers
Item
No Healthy Volunteers
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
Type 1 or 2 diabetes
boolean
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
IclusionCriterion_2
Item
18 Years and older
boolean
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
InclusionCriterion_3
Item
HbA1c less than or equal to 11%
boolean
C0366781 (UMLS CUI)
4548-4 (LNC)
InclusionCriterion_4
Item
Mild to very severe non-proliferative diabetic retinopathy in the study eye
boolean
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
InclusionCriterion_5
Item
Clinically significant macular edema in the study eye not within 100 microns of center of macula
boolean
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Item Group
Exclusion criteria
ExclusionCriterion_1
Item
Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
boolean
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
C0743733 (UMLS CUI)
10057105 (MDR)
ExclusionCriterion_2
Item
Glaucoma in the study eye
boolean
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
Unstable cardiovascular disease
boolean
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
ExclusionCriterion_4
Item
Major surgery within past 3 months
boolean
C0679637 (UMLS CUI)
ExclusionCriterion_5
Item
Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
boolean
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
C0392920 (UMLS CUI)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)
Item Group
Medical Concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Healthy Subject
Item
Healthy Subject
string
C1708335 (UMLS CUI)
Diabetes Mellitus
Item
Diabetes Mellitus
string
C0011849 (UMLS CUI)
E08-E13 (ICD10CM)
250 (ICD9CM)
MTHU020781 (LNC)
10012602 (MDR)
73211009 (SNOMED CT 2010_0731)
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Item
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
string
C0366781 (UMLS CUI)
4548-4 (LNC)
Diabetic Retinopathy
Item
Diabetic Retinopathy
string
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
Macular retinal edema
Item
Macular retinal edema
string
C0271051 (UMLS CUI)
10025415 (MDR)
37231002 (SNOMED CT 2010_0731)
Ophthalmologic Surgical Procedures
Item
Ophthalmologic Surgical Procedures
string
C0038901 (UMLS CUI)
373353005 (SNOMED CT 2010_0731)
Eye laser surgery
Item
Eye laser surgery
string
C0743733 (UMLS CUI)
10057105 (MDR)
Glaucoma
Item
Glaucoma
string
C0017601 (UMLS CUI)
E10392 (CTCAE)
H40-H42 (ICD10CM)
365 (ICD9CM)
MTHU020819 (LNC)
10018304 (MDR)
23986001 (SNOMED CT 2010_0731)
Cardiovascular Diseases
Item
Cardiovascular Diseases
string
C0007222 (UMLS CUI)
429.2 (ICD9CM)
10007649 (MDR)
49601007 (SNOMED CT 2010_0731)
major surgery
Item
major surgery
string
C0679637 (UMLS CUI)
Abnormal renal function
Item
Abnormal renal function
string
C0151746 (UMLS CUI)
10038451 (MDR)
39539005 (SNOMED CT 2010_0731)
Liver Dysfunction
Item
Liver Dysfunction
string
C0086565 (UMLS CUI)
10019670 (MDR)
75183008 (SNOMED CT 2010_0731)
Malignant Neoplasms
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
Chemotherapy Regimen
Item
Chemotherapy Regimen
string
C0392920 (UMLS CUI)
10061758 (MDR)
367336001 (SNOMED CT 2010_0731)
Therapeutic radiology procedure
Item
Therapeutic radiology procedure
string
C1522449 (UMLS CUI)
10037794 (MDR)
108290001 (SNOMED CT 2010_0731)

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