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Effect of Ruboxistaurin on Clinically Significant Macular Edema

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ruboxistaurin

Placebo

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ruboxistaurin

Placebo

Arm Description

32 mg taken orally daily for up to 48 months

Taken orally daily for up to 48 months

Outcomes

Primary Outcome Measures

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

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

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

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

Change From Baseline to Month 24 in Contrast Sensitivity

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

Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24

Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24

Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24

Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.

Full Information

NCT ID

NCT00133952

First Posted

August 22, 2005

Last Updated

August 25, 2016

Sponsor

Chromaderm, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00133952

Brief Title

Effect of Ruboxistaurin on Clinically Significant Macular Edema

Official Title

The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chromaderm, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

309 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ruboxistaurin

Arm Type

Experimental

Arm Description

32 mg taken orally daily for up to 48 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Taken orally daily for up to 48 months

Intervention Type

Drug

Intervention Name(s)

Ruboxistaurin

Other Intervention Name(s)

LY333531

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline through 48 months

Secondary Outcome Measure Information:

Title

Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula

Description

Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.

Time Frame

Baseline, 24 months

Title

Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24

Description

Time Frame

Baseline through 24 months

Title

Time to Focal Photocoagulation

Time Frame

Baseline through 48 months

Title

Change From Baseline to Month 24 in Contrast Sensitivity

Description

Time Frame

Baseline, 24 months

Title

Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula

Time Frame

Baseline, up to 24 months

Title

Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24

Time Frame

Baseline through 24 months

Title

Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24

Time Frame

Baseline through 24 months

Title

Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24

Description

Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.

Time Frame

Baseline through 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Karl Beutner

Organizational Affiliation

Chromaderm, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

City

Artesia

State/Province

California

ZIP/Postal Code

90701

Country

United States

Facility Name

City

Newark

State/Province

Delaware

ZIP/Postal Code

19713

Country

United States

Facility Name

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46280

Country

United States

Facility Name

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49525

Country

United States

Facility Name

City

Portsmouth

State/Province

New Hampshire

ZIP/Postal Code

03801

Country

United States

Facility Name

City

Slingerlands

State/Province

New York

ZIP/Postal Code

12159

Country

United States

Facility Name

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

City

Lakewood

State/Province

Ohio

ZIP/Postal Code

44107

Country

United States

Facility Name

City

Kingston

State/Province

Pennsylvania

ZIP/Postal Code

18704

Country

United States

Facility Name

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

City

West Mifflin

State/Province

Pennsylvania

ZIP/Postal Code

15122

Country

United States

Facility Name

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4G5

Country

Canada

Facility Name

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L4W 1W0

Country

Canada

Facility Name

City

Aarhus

ZIP/Postal Code

8000

Country

Denmark

Facility Name

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

City

Bonn

ZIP/Postal Code

53127

Country

Germany

Facility Name

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

City

Ulm

ZIP/Postal Code

89075

Country

Germany

Facility Name

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

City

Mexico City

ZIP/Postal Code

6700

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78395

Country

Mexico

Facility Name

City

Coimbra

ZIP/Postal Code

3000-548

Country

Portugal

Facility Name

City

Lisbon

ZIP/Postal Code

1150-199

Country

Portugal

Facility Name

City

Porto

ZIP/Postal Code

4202-451

Country

Portugal

Facility Name

City

Bucharest

ZIP/Postal Code

050098

Country

Romania

Facility Name

City

Alicante

ZIP/Postal Code

03016

Country

Spain

Facility Name

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

City

Valladolid

ZIP/Postal Code

47071

Country

Spain

Facility Name

City

London

State/Province

Greater London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

EC1V 2PD

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

23404115

Citation

Sheetz MJ, Aiello LP, Davis MD, Danis R, Bek T, Cunha-Vaz J, Shahri N, Berg PH; MBDL and MBCU Study Groups. The effect of the oral PKC beta inhibitor ruboxistaurin on vision loss in two phase 3 studies. Invest Ophthalmol Vis Sci. 2013 Mar 11;54(3):1750-7. doi: 10.1167/iovs.12-11055.

Results Reference

derived

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Effect of Ruboxistaurin on Clinically Significant Macular Edema

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