Diabetic Macular EdemaPhase 3NCT00133952

Effect of Ruboxistaurin on Clinically Significant Macular Edema

A Phase 3 study testing Ruboxistaurin in people with Diabetic Macular Edema, run by Chromaderm, Inc. at 41 sites in 10 countries.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Macular Edema
What is being tested?: Ruboxistaurin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 309 participants
Where: 41 sitesin 10 countries
Study dates: Aug 2005to Jul 2011
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

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

Who cannot join

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.

Trial locations and contacts

41 sites in 10 countries.

Country

City, postcode or hospital

41 sites in 10 countries

United States19 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.
Artesia, California, 90701
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Asheville, North Carolina, 28803
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Augusta, Georgia, 30909
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Baltimore, Maryland, 21287
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Boston, Massachusetts, 02215
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Dallas, Texas, 75231
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Grand Rapids, Michigan, 49525
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Houston, Texas, 77030
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Indianapolis, Indiana, 46280
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Jacksonville, Florida, 32204
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Kingston, Pennsylvania, 18704
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Lakewood, Ohio, 44107
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Newark, Delaware, 19713
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Phoenix, Arizona, 85020
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Pittsburgh, Pennsylvania, 15213
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Portsmouth, New Hampshire, 03801
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San Antonio, Texas, 78229
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Slingerlands, New York, 12159
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West Mifflin, Pennsylvania, 15122

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Germany4 sites

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Bonn, 53127
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Leipzig, 04103
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Münster, 48145
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Ulm, 89075

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Canada3 sites

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Halifax, Nova Scotia, B3H 2Y9
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London, Ontario, N6A 4G5
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Mississauga, Ontario, L4W 1W0

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Mexico3 sites

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Mexico City, 6700
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Monterrey, 64710
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San Luis Potosí City, 78395

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Portugal3 sites

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Coimbra, 3000-548
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Lisbon, 1150-199
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Porto, 4202-451

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Spain3 sites

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Alicante, 03016
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Barcelona, 08022
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Valladolid, 47071

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Denmark2 sites

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Aarhus, 8000
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Glostrup Municipality, 2600

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United Kingdom2 sites

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London, Greater London, SE5 9RS
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London, EC1V 2PD

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Lithuania1 site

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Kaunas, LT-50009

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Romania1 site

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Bucharest, 050098

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About this study

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

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.

Conditions: Diabetic Macular Edema
Being tested: Ruboxistaurin, Placebo

What participants receive

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

RuboxistaurinDrug
Also called LY333531
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT00133952
Study group	Role	What they receive
Ruboxistaurin	Experimental	32 mg taken orally daily for up to 48 months Receives: Drug: Ruboxistaurin
Placebo	Placebo comparator	Taken orally daily for up to 48 months Receives: Drug: Placebo

What is being measured

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

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).
Measured: Baseline through 48 months

Secondary outcomes (8)

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.
Measured: Baseline, 24 months
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).
Measured: Baseline through 24 months
Time to Focal Photocoagulation
Measured: Baseline through 48 months
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.
Measured: Baseline, 24 months
Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula
Measured: Baseline, up to 24 months
Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24
Measured: Baseline through 24 months
Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24
Measured: Baseline through 24 months
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.
Measured: Baseline through 24 months

Timeline

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

Aug 2005Jul 2011

First posted24 Aug 2005 (estimated)
Study startAug 2005
Primary completionJul 2011
Study completionJul 2011

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetic Macular EdemaStudies 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 309 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00133952
Sponsor's protocol ID: 5882
Other IDs: B7A-MC-MBCU
Status last verified: Aug 2016
First submitted: 22 Aug 2005
Last updated: 6 Oct 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 23404115

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

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema 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: The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema
ClinicalTrials.gov ID: NCT00133952
Acronym / sponsor ID: 5882
Conditions: Diabetic Macular Edema
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 309 participants (actual)
Lead sponsor: Chromaderm, Inc.Industry (pharma, biotech, devices)
Study start: Aug 2005
Primary completion: Jul 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 24 Aug 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: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Ruboxistaurin	Experimental	Drug: Ruboxistaurin32 mg taken orally daily for up to 48 months
Placebo	Placebo comparator	Drug: PlaceboTaken orally daily for up to 48 months

Who may qualify

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

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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.

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: LY333531Administered orally	Drug	Ruboxistaurin
PlaceboAdministered orally	Drug	Placebo

Primary outcome

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

8 secondary outcomes

Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula
Time frame: Baseline, 24 months
Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24
Time frame: Baseline through 24 months
Time to Focal Photocoagulation
Time frame: Baseline through 48 months
Change From Baseline to Month 24 in Contrast Sensitivity
Time frame: Baseline, 24 months
Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula
Time frame: Baseline, up to 24 months
Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24
Time frame: Baseline through 24 months
Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24
Time frame: Baseline through 24 months
Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24
Time frame: Baseline through 24 months

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
Placebo	157	115
Ruboxistaurin	152	124

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

Time frame: Baseline through 48 months. Number. Unit: percent of participants

Measure	Placebo n = 146	Ruboxistaurin n = 138
Value	3.4	2.2

Placebo vs Ruboxistaurin: Odds Ratio (OR): 0.63 (95% CI 0.15 to 2.67), p = 0.724, Fisher Exact

Population analysed: All randomized participants who took at least 1 dose of study drug and had post-baseline SMVL measurements.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	31 of 153 (20.3%)	112 of 153 (73.2%)	Not reported
Ruboxistaurin	36 of 149 (24.2%)	118 of 149 (79.2%)	Not reported

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.
Derived from this study: PubMed 23404115Sheetz 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.
Lilly Clinical Trial RegistryLink provided by the sponsor.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

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.

41 sites in 10 countries: 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 Macular Edema, run by Chromaderm, Inc. at 41 sites in 10 countries.

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 5 inclusion and 5 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 41 sites in United States, Germany, Canada, Mexico, Portugal and 5 more countries. 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. Some participants in this study may receive a placebo. 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?

Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48 (time frame: Baseline through 48 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 NCT00133952, which also lists 1 linked publication.

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.