Effect of Ruboxistaurin on Clinically Significant Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00133952
First received: August 22, 2005
Last updated: September 20, 2011
Last verified: July 2011
  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 3

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:


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:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 17, 2014