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

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00133952

Purpose

The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin for approximately 24 months will reduce the baseline to endpoint changes in macular thickness, as measured by optical coherence tomography (OCT), in patients with clinically significant macular edema.

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Effect of Ruboxistaurin on Clinically Significant Macular Edema in Patients With Diabetes Mellitus, as Assessed by Optical Coherence Tomography

Resource links provided by NLM:

Genetics Home Reference related topics: 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:

Central macular thickness by OCT. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of sustained moderate visual loss (SMVL) as assessed by best correctred ETDRS visual acuity. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Mean retinal thickness by OCT [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Occurrence of significant center-involved macular edema, as assessed by OCT [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Photocoagulation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Contrast sensitivity using the Pelli-Robson chart [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Macular edema volume measures [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	August 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: ruboxistaurin 32 mg tablet daily for up to 48 months
2: Placebo Comparator	Drug: Placebo One tablet daily for up to 48 months.

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 ( Chief Medical Officer )
Study ID Numbers:	5882, B7A-MC-MBCU
Study First Received:	August 22, 2005
Last Updated:	July 30, 2009
ClinicalTrials.gov Identifier:	NCT00133952 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Signs and Symptoms
Macular Edema
Molecular Mechanisms of Pharmacological Action
Ruboxistaurin
Eye Diseases
Retinal Degeneration

Macular Degeneration
Edema
Enzyme Inhibitors
Pharmacologic Actions
Retinal Diseases

ClinicalTrials.gov processed this record on November 27, 2009