Diabetic RetinopathyPhase 3NCT00266695

Treatment for Completers of the Study B7A-MC-MBCM

A Phase 3 study testing Ruboxistaurin in people with Diabetic Retinopathy, run by Chromaderm, Inc. at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Retinopathy
What is being tested?: Ruboxistaurin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 203 participants
Where: 29 sitesUnited States
Study dates: Jan 2006to Aug 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

29 sites in 1 country.

City, postcode or hospital

29 sites in 1 country

United States29 sites

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
Baltimore, Maryland, 21287
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Beachwood, Ohio, 44122
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Boston, Massachusetts, 02215
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Charlotte, North Carolina, 28210
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Cincinnati, Ohio, 45242
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Columbia, Missouri, 65212
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Columbia, South Carolina, 29203
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Dallas, Texas, 75231
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Grand Rapids, Michigan, 49525
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Hamden, Connecticut, 06518
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Hershey, Pennsylvania, 17033
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Honolulu, Hawaii, 96813
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Huntington Beach, California, 92647
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Indianapolis, Indiana, 46280
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Madison, Wisconsin, 53705
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Mesa, Arizona, 85210
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Newark, Delaware, 19713
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Orange, California, 92868
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Phoenix, Arizona, 85014
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Pittsburgh, Pennsylvania, 15213
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Rapid City, South Dakota, 57701
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Royal Oak, Michigan, 48073
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Sacramento, California, 95817
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Salt Lake City, Utah, 84107
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Shawnee Mission, Kansas, 66204
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Staten Island, New York, 10305
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Tampa, Florida, 33609
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Towson, Maryland, 21204
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Wheaton, Illinois, 60187

Other trials in United States

About this study

Official title: Open-Label Treatment for Patients Completing Study B7A-MC-MBCM

Conditions: Diabetic Retinopathy
Being tested: Ruboxistaurin
Medical subject headings: Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RuboxistaurinDrug
Also called LY 333531, Arxxant
32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.

Study groups in NCT00266695
Study group	Role	What they receive
Ruboxistaurin	Experimental	Not described Receives: Drug: Ruboxistaurin

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Baseline, 18 months up to 24 months

Secondary outcomes (6)

Vision Loss
The number of participants whose best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in at least 1 diabetic retinopathy (DR) study eye decreased by 15-letters or less from the conclusion of Study MBCM to the start of Study MBDV, 6 to 18 months later. 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).
Measured: End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months
Sustained Moderate Vision Loss (SMVL), Long Term
The number of participants who experienced SMVL, long term, in at least 1 diabetic retinopathy (DR) study eye. Long term SMVL was a ≥15-letter decrease from Study MBCM baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that was sustained for the last 6 months of Study MBDV. 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).
Measured: 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
An mSMVL event was defined as a ≥15-letter decrease from Study MBDV baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) during any 6-month period, not just the last 6 months of the study. An mSMVL event was the first occurrence of an mSMVL in a participant, and the time at which the mSMVL began was used as the time of the event for the analysis. VA was measured at 4 meters (m) using an eye chart with 5 letters per 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.
Measured: 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
Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (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). A higher score represented better VA.
Measured: Month 24
Number of Participants Receiving Treatment With Focal/Grid Photocoagulation
Measured: Baseline up to Month 24
Number of Participants Receiving Treatment With Panretinal Photocoagulation
Measured: Baseline up to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2006Aug 2008

First posted19 Dec 2005 (estimated)
Study startJan 2006
Primary completionAug 2008
Study completionAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 203 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00266695
Sponsor's protocol ID: 10699
Other IDs: B7A-MC-MBDV
Status last verified: Aug 2016
First submitted: 15 Dec 2005
Last updated: 6 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetic Retinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label Treatment for Patients Completing Study B7A-MC-MBCM
ClinicalTrials.gov ID: NCT00266695
Acronym / sponsor ID: 10699
Conditions: Diabetic Retinopathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 203 participants (actual)
Lead sponsor: Chromaderm, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 19 Dec 2005 (estimated)
Results: Posted 28 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ruboxistaurin	Experimental	Drug: Ruboxistaurin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RuboxistaurinAlso: LY 333531, Arxxant32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.	Drug	Ruboxistaurin

Primary outcome

Sustained Moderate Visual Loss (SMVL)
Time frame: Baseline, 18 months up to 24 months
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).

6 secondary outcomes

Vision Loss
Time frame: End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months
Sustained Moderate Vision Loss (SMVL), Long Term
Time frame: 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
Time frame: 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
Time frame: Month 24
Number of Participants Receiving Treatment With Focal/Grid Photocoagulation
Time frame: Baseline up to Month 24
Number of Participants Receiving Treatment With Panretinal Photocoagulation
Time frame: Baseline up to Month 24

Results and safety

Results posted to the registry on 28 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ruboxistaurin	203	174

Primary outcome: Sustained Moderate Visual Loss (SMVL)

Time frame: Baseline, 18 months up to 24 months. Number. Unit: participants

Measure	Ruboxistaurin n = 203
Value	10 (2 to 9)

Population analysed: All enrolled participants.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ruboxistaurin	57 of 203 (28.1%)	166 of 203 (81.8%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karl Beutner study director

Chromaderm, Inc.

29 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ruboxistaurin in people with Diabetic Retinopathy, run by Chromaderm, Inc. at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sustained Moderate Visual Loss (SMVL) (time frame: Baseline, 18 months up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00266695.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2016.