The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin for approximately 18 months will reduce the baseline to endpoint changes in macular thickness, as measured by Optical Coherence Tomography, in patients with clinically significant macular edema.

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: ruboxistaurin	Phase II

Further Study Details: 

Primary Outcomes: - Change from baseline to endpoint in absolute retinal thickness at the center of the macula, as determined by OCT.
Secondary Outcomes: - Change from baseline to endpoint in visual acuity.; - Change from baseline to endpoint in mean retinal thickness, as assessed by OCT.; - Occurrence of significant center-involved macular edema, as assessed by OCT.; - Occurrence of other measures or treatments of diabetic macular edema or visual function.
Expected Total Enrollment:  220

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Type 1 or 2 diabetes
• 18 years or older
• HbA1c <= 11%
• Mild to very severe non-proliferative diabetic retinopathy in the study eye
• Clinically significant macular edema in the study eye

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 have malignancy requiring chemotherapy or radiation therapy.

Please refer to this study by ClinicalTrials.gov identifier  NCT00133952

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or      1-317-615-4559 

California
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Artesia,  California,  90701,  United States; Not yet recruiting
Delaware
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Newark,  Delaware,  19713,  United States; Not yet recruiting
Florida
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Jacksonville,  Florida,  32204,  United States; Not yet recruiting
Maryland
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Baltimore,  Maryland,  21287,  United States; Not yet recruiting
Massachusetts
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Boston,  Massachusetts,  02215,  United States; Not yet recruiting
Ohio
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Cleveland,  Ohio,  44195,  United States; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Lakewood,  Ohio,  44107,  United States; Recruiting
Oklahoma
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Oklahoma City,  Oklahoma,  73104,  United States; Not yet recruiting
Pennsylvania
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Pittsburgh,  Pennsylvania,  15213,  United States; Not yet recruiting
Texas
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Dallas,  Texas,  75231,  United States; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Houston,  Texas,  77030,  United States; Not yet recruiting
Denmark
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Herlev,  2730,  Denmark; Recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Aarhus C,  DK-8000,  Denmark; Not yet recruiting
France
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Paris,  75010,  France; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Paris,  75012,  France; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT- 5 hours, EST), or speak with your personal physician., Nantes,  44093,  France; Not yet recruiting
Germany
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ulm,  89175,  Germany; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Munster,  48145,  Germany; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bonn,  53127,  Germany; Not yet recruiting
Portugal
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Coimbra,  3000-548,  Portugal; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lisboa,  1150-199,  Portugal; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Lisboa,  1169-019,  Portugal; Not yet recruiting
Spain
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Alicante,  03016,  Spain; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Valladolid,  47005,  Spain; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Barcelona,  08022,  Spain; Not yet recruiting
United Kingdom
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Birmingham,  B9 5SS,  United Kingdom; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, London,  EC1V 2PD,  United Kingdom; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Liverpool,  L7 8XP,  United Kingdom; Not yet recruiting
      For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT- 5 hours, EST), or speak with your personal physician, Southampton,  S0166YD,  United Kingdom; Not yet recruiting

Study chairs or principal investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT- 5 hours, EST),  Study Director,  Eli Lilly and Company   

Study ID Numbers:  5882
Last Updated:  August 23, 2005
Record first received:  August 22, 2005
ClinicalTrials.gov Identifier:  NCT00133952
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-30