Effect of Ruboxistaurin on Clinically Significant Macular Edema - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by (Responsible Party):	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00133952

Purpose

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.

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: Ruboxistaurin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Ruboxistaurin

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Proportion of participants with sustained moderate visual Loss (SMVL) [ Time Frame: Up to 48 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in mean retinal thickness within 500 microns of the center of the macula [ Time Frame: Baseline, up to 24 months ] [ Designated as safety issue: No ]
Number of participants with significant center-involved macular edema [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Time to focal photocoagulation [ Time Frame: Up to 48 months ] [ Designated as safety issue: No ]
Change from baseline in contrast sensitivity [ Time Frame: Baseline, up to 24 months ] [ Designated as safety issue: No ]
Change from baseline in retinal thickness at the center of the macula [ Time Frame: Baseline, up to 24 months ] [ Designated as safety issue: No ]
Number of participants requiring focal photocoagulation [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Number of participants not requiring focal photocoagulation [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
Number of participants requiring repeat focal photocoagulation [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]

Enrollment:	308
Study Start Date:	August 2005
Study Completion Date:	July 2011
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Ruboxistaurin 32 mg taken orally daily for up to 48 months	Drug: Ruboxistaurin Administered orally Other Name: LY333531
Placebo Comparator: Placebo taken orally daily for up to 48 months	Drug: Placebo Administered orally

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 or 2 diabetes
18 years or 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133952

Show 41 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00133952 History of Changes
Other Study ID Numbers:	5882, B7A-MC-MBCU
Study First Received:	August 22, 2005
Last Updated:	September 20, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases

Eye Diseases
Ruboxistaurin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012