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Effect of Ruboxistaurin on Clinically Significant Macular Edema

NCT ID: NCT00133952

Last Updated: 2016-10-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

309 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ruboxistaurin

32 mg taken orally daily for up to 48 months

Group Type EXPERIMENTAL

Ruboxistaurin

Intervention Type DRUG

Administered orally

Placebo

Taken orally daily for up to 48 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Ruboxistaurin

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY333531

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chromaderm, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karl Beutner

Role: STUDY_DIRECTOR

Chromaderm, Inc.

Locations

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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.

Phoenix, Arizona, United States

Site Status

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Artesia, California, United States

Site Status

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Newark, Delaware, United States

Site Status

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Jacksonville, Florida, United States

Site Status

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Augusta, Georgia, United States

Site Status

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Indianapolis, Indiana, United States

Site Status

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Baltimore, Maryland, United States

Site Status

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Boston, Massachusetts, United States

Site Status

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Grand Rapids, Michigan, United States

Site Status

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Portsmouth, New Hampshire, United States

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Slingerlands, New York, United States

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Asheville, North Carolina, United States

Site Status

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Lakewood, Ohio, United States

Site Status

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Kingston, Pennsylvania, United States

Site Status

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Pittsburgh, Pennsylvania, United States

Site Status

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West Mifflin, Pennsylvania, United States

Site Status

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Dallas, Texas, United States

Site Status

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Houston, Texas, United States

Site Status

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San Antonio, Texas, United States

Site Status

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Halifax, Nova Scotia, Canada

Site Status

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London, Ontario, Canada

Site Status

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Mississauga, Ontario, Canada

Site Status

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Aarhus, , Denmark

Site Status

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Glostrup Municipality, , Denmark

Site Status

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Bonn, , Germany

Site Status

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Leipzig, , Germany

Site Status

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Münster, , Germany

Site Status

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Ulm, , Germany

Site Status

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Kaunas, , Lithuania

Site Status

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Mexico City, , Mexico

Site Status

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Monterrey, , Mexico

Site Status

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San Luis Potosí City, , Mexico

Site Status

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Coimbra, , Portugal

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Lisbon, , Portugal

Site Status

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Porto, , Portugal

Site Status

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Bucharest, , Romania

Site Status

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Alicante, , Spain

Site Status

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Barcelona, , Spain

Site Status

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Valladolid, , Spain

Site Status

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London, Greater London, United Kingdom

Site Status

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London, , United Kingdom

Site Status

Countries

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United States Canada Denmark Germany Lithuania Mexico Portugal Romania Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 23404115 (View on PubMed)

Other Identifiers

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B7A-MC-MBCU

Identifier Type: OTHER

Identifier Source: secondary_id

5882

Identifier Type: -

Identifier Source: org_study_id

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