Brief Summary

To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

203

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Jan 2006

Typical duration for phase_3

Geographic Reach

1 country

29 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

December 15, 2005

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 19, 2005

Completed

13 days until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed

2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed

7.5 years until next milestone

Results Posted

Study results publicly available

January 28, 2016

Completed

Last Updated

October 6, 2016

Status Verified

August 1, 2016

Enrollment Period

2.6 years

First QC Date

December 15, 2005

Results QC Date

December 22, 2015

Last Update Submit

August 25, 2016

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

Sustained Moderate Visual Loss (SMVL)
The number of participants who experienced SMVL in at least 1 diabetic retinopathy (DR) study eye. SMVL was a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of the study. Best-corrected ETDRS VA was measured at 4 meters (m) using an eye chart with 5 letters per row of decreasing letter size in each successive row. Participants read the chart from the top down until reaching a row where ≥3 letters in the row could not be read correctly. If \<20 letters were read correctly at 4 m, the chart was re-read at 1 m. The best-corrected ETDRS VA score was the total number of letters read correctly per eye at 4 m, plus a correction factor of 30 if ≥20 letters were read correctly at 4 m, plus the total number of letters read correctly at 1 m, if assessed. Best-corrected ETDRS VA scores ranged from 0 (no letters read correctly) to 100 (all letters read correctly).
Baseline, 18 months up to 24 months

Secondary Outcomes (6)

Vision Loss
End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months
Sustained Moderate Vision Loss (SMVL), Long Term
Baseline in Study MBCM, 18 months up to 24 months in Study MBDV (for a total of 75 up to 87 months of SMVL, long term)
Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval
Baseline up to 6 months, 6 months up to 12 months, 12 months up to 18 months, 18 months up to 24 months, and 24 months up to 30 months
Visual Acuity
Month 24
Number of Participants Receiving Treatment With Focal/Grid Photocoagulation
Baseline up to Month 24
+1 more secondary outcomes

Study Arms (1)

Ruboxistaurin

EXPERIMENTAL

Drug: Ruboxistaurin

Interventions

RuboxistaurinDRUG

32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.

Also known as: LY 333531, Arxxant

Ruboxistaurin

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients that completed Month 36 (Visit 15) of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment.

You may not qualify if:

Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Chromaderm, Inc.lead

Study Sites (29)

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. test

Mesa, Arizona, 85210, United States

Location

Phoenix, Arizona, 85014, United States

Location

Huntington Beach, California, 92647, United States

Location

Orange, California, 92868, United States

Location

Sacramento, California, 95817, United States

Location

Hamden, Connecticut, 06518, United States

Location

Newark, Delaware, 19713, United States

Location

Tampa, Florida, 33609, United States

Location

Honolulu, Hawaii, 96813, United States

Location

Wheaton, Illinois, 60187, United States

Location

Indianapolis, Indiana, 46280, United States

Location

Shawnee Mission, Kansas, 66204, United States

Location

Baltimore, Maryland, 21287, United States

Location

Towson, Maryland, 21204, United States

Location

Boston, Massachusetts, 02215, United States

Location

Grand Rapids, Michigan, 49525, United States

Location

Royal Oak, Michigan, 48073, United States

Location

Columbia, Missouri, 65212, United States

Location

Staten Island, New York, 10305, United States

Location

Charlotte, North Carolina, 28210, United States

Location

Beachwood, Ohio, 44122, United States

Location

Cincinnati, Ohio, 45242, United States

Location

Hershey, Pennsylvania, 17033, United States

Location

Pittsburgh, Pennsylvania, 15213, United States

Location

Columbia, South Carolina, 29203, United States

Location

Rapid City, South Dakota, 57701, United States

Location

Dallas, Texas, 75231, United States

Location

Salt Lake City, Utah, 84107, United States

Location

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

ruboxistaurin

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Limitations and Caveats

A participant could have one or both eyes meet the criteria for a diabetic retinopathy (DR) study eye as defined in study B7A-MC-MBCM.

Results Point of Contact

Title: info@chroma-derm.com
Organization: Chromaderm

Study Officials

Karl Beutner
Chromaderm, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

December 15, 2005

First Posted

December 19, 2005

Study Start

January 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 6, 2016

Results First Posted

January 28, 2016

Record last verified: 2016-08

Locations

US(29)

Treatment for Completers of the Study B7A-MC-MBCM

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Ruboxistaurin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Ruboxistaurin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (29)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations