Effect of Ruboxistaurin on Clinically Significant Macular Edema

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Placebo; Drug: Ruboxistaurin

• Registration Number: NCT00133952
• Lead Sponsor: Chromaderm, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-24
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Disposition First Submitted: 2011-09-20
• Disposition First Submitted QC: 2011-09-20
• Disposition First Posted: 2011-09-26
• Results First Submitted: 2015-12-22
• Results First Submitted QC: 2015-12-22
• Results First Posted: 2016-01-28
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-25
• Last Update Posted: 2016-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Taken orally daily for up to 48 months
Ruboxistaurin	Ruboxistaurin	32 mg taken orally daily for up to 48 months

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48	Baseline through 48 months	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

Name	Time	Method
Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24	Baseline through 24 months	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).
Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula	Baseline, 24 months	Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.
Time to Focal Photocoagulation	Baseline through 48 months
Change From Baseline to Month 24 in Contrast Sensitivity	Baseline, 24 months	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	Baseline, up to 24 months
Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24	Baseline through 24 months
Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24	Baseline through 24 months	Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.
Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24	Baseline through 24 months

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇬🇧 London, United Kingdom