Effect of Ruboxistaurin on Clinically Significant Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chromaderm, Inc.
ClinicalTrials.gov Identifier:
NCT00133952
First received: August 22, 2005
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence 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 Chromaderm, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48 [ Time Frame: Baseline through 48 months ] [ Designated as safety issue: No ]
    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 participant's last 6 months of study participation. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly).


Secondary Outcome Measures:
  • Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

  • Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24 [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
    Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula >2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).

  • Time to Focal Photocoagulation [ Time Frame: Baseline through 48 months ] [ Designated as safety issue: No ]
  • Change From Baseline to Month 24 in Contrast Sensitivity [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

  • Change From Baseline to Month 24 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 at Any Time From Baseline Through Month 24 [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
  • Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24 [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
  • Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24 [ Time Frame: Baseline through 24 months ] [ Designated as safety issue: No ]
    Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.


Enrollment: 309
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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or 2 diabetes
  • 18 years or older
  • Hemoglobin A1c (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 41 Study Locations
Sponsors and Collaborators
Chromaderm, Inc.
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chromaderm, Inc.
ClinicalTrials.gov Identifier: NCT00133952     History of Changes
Other Study ID Numbers: 5882  B7A-MC-MBCU 
Study First Received: August 22, 2005
Results First Received: December 22, 2015
Last Updated: July 25, 2016
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

ClinicalTrials.gov processed this record on August 24, 2016