Description:

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.

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  1. 12/9/13
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December 9, 2013

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License:
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00133952 # Diabetes Mellitus

Details

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
No Healthy Volunteers
Type 1 or 2 diabetes
18 Years and older
HbA1c less than or equal to 11%
Mild to very severe non-proliferative diabetic retinopathy in the study eye
Clinically significant macular edema in the study eye not within 100 microns of center of macula
Exclusion criteria
Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
Glaucoma in the study eye
Unstable cardiovascular disease
Major surgery within past 3 months
Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
Medical Concepts
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