Diabetic RetinopathyPhase 3NCT00090519
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
A Phase 3 study testing ruboxistaurin in people with Diabetic Retinopathy, run by Chromaderm, Inc. at 84 sites in 17 countries.
Trial summary
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes. 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?
- Yes, some participants may receive a placebo
- How many people
- 731 participants
- Where
- 84 sitesin 17 countries
- Study dates
- Feb 2004to Apr 2010
- 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 Type 2 diabetes
- 18 years or older
- Non-clinically significant diabetic macular edema
- Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye
- Relatively good vision (20/30 or better)
Who cannot join
- Surgery or laser treatment in the study eye
- Glaucoma in the study eye
- Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
- Liver disease, dialysis or renal transplant
Trial locations and contacts
84 sites in 17 countries.
84 sites in 17 countries
United States36 sites
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Albuquerque, New Mexico, 87102
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Arlington, Texas, 76012
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Artesia, California, 90701
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Augusta, Georgia, 30909
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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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Cleveland, Ohio, 44195
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Columbia, Missouri, 65212
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Dallas, Texas, 75231
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Denver, Colorado, 80262
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Fargo, North Dakota, 58104
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Grand Rapids, Michigan, 49525
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Hershey, Pennsylvania, 17033
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Houston, Texas, 77030
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Idaho Falls, Idaho, 83404
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Independence, Missouri, 64055
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32204
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New Brunswick, New Jersey, 08901
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New London, Connecticut, 06320
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Ogden, Utah, 84403
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Oklahoma City, Oklahoma, 73104
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Palm Springs, California, 92262
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Peabody, Massachusetts, 01960
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Pittsburgh, Pennsylvania, 15213
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Poway, California, 92064
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Rapid City, South Dakota, 57701
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Rockville Centre, New York, 11570
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Salt Lake City, Utah, 84107
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Sunrise, Florida, 33351
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Teaneck, New Jersey, 07666
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Walnut Creek, California, 94598
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Wheaton, Illinois, 60187
Canada6 sites
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Halifax, Nova Scotia, B3H 2Y9
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London, Ontario, N6A 4G5
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Montreal, Quebec, H2L 4M1
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Ottawa, Ontario, K1H 1A2
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Toronto, Ontario, M4N 3M5
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Vancouver, British Columbia, V5Z 4E1
Australia5 sites
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Nedlands, Western Australia, 6009
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Parramatta, New South Wales, 2150
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Sydney, New South Wales, 2000
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Westmead, New South Wales, 2145
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Woodville, South Australia, 5011
United Kingdom5 sites
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Aberdeen, Scotland, AB25 2ZN
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Birmingham, West Midlands, B9 5SS
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Bristol, BS1 2LX
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Liverpool, Merseyside, L7 8XP
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London, EC1V 2PD
Germany4 sites
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Leipzig, 04103
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Münster, 48145
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Sulzbach, 66280
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Ulm, D-89075
Poland4 sites
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Bydgoszcz, 85-822
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Katowice, 40-044
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Lublin, 20-081
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Poznan, 61-696
Spain4 sites
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Alicante, 03015
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Barcelona, 08022
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Madrid, 28002
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Valladolid, 47005
Brazil3 sites
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Curitiba, 80420-170
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Goiânia, 74210-010
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São Paulo, 05403-010
France3 sites
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Bordeaux, 33076
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Nantes, 44093
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Paris, 75010
India3 sites
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Chennai, 600006
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Hyderabaad, 500034
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New Delhi, 110029
Denmark2 sites
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Aarhus, 8000
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Glostrup Municipality, 2600
Italy2 sites
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Milan, 20132
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Udine, 33100
Netherlands2 sites
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Amsterdam, 1081 HV
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Rotterdam, 3011 BH
Russia2 sites
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Moscow, 117036
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Saint Petersburg, 195176
Mexico1 site
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Mexico City, 04030
Portugal1 site
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Coimbra, 3000-548
Taiwan1 site
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Taoyuan, 333
About this study
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
- Conditions
- Diabetic Retinopathy
- Being tested
- ruboxistaurin, placebo
- 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 LY333531, Arxxant
32 mg once daily (QD) oral for up to 36 months
placeboDrug
QD oral for up to 36 months
| Study group | Role | What they receive |
|---|---|---|
| Ruboxistaurin | Experimental | 32 milligrams (mg) once daily (QD) oral for up to 36 months Receives: Drug: ruboxistaurin |
| Placebo | Placebo comparator | QD oral for up to 36 months Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.
Measured: 6 Months through 36 Months
Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.
Measured: Baseline, 36 Months
Secondary outcomes (8)
Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months
ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity. Results are reported based on the number of diabetic retinopathy (DR) eyes.
Measured: Baseline, 36 Months
First Occurrence of Focal/Grid Photocoagulation
The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.
Measured: Baseline through 36 Months
Change From Baseline in Contrast Sensitivity by Pelli-Robson
Pelli-Robson chart read from left to right + from top to bottom. Each line has 2 groups, each of 3 letters. Letters in each group have same contrast. Contrast in each successive group is less than the preceding group. Participant reads letters starting with highest contrast, continues until 2 or 3 letters in 1 group are incorrectly named. Scored on key showing all letters at full contrast, gives the log contrast sensitivity corresponding to each group. Score is determined by previous group (last group in which 2 or 3 letters were correctly named). Results reported based on number of DR eyes.
Measured: Baseline, 36 Months
Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography
Participants were classified as having experienced progression or no progression of DR by 36-month visit. Progression of DR=3 steps on ETDRS retinopathy severity person scale for participants with both eyes less than proliferative diabetic retinopathy (PDR) at baseline OR 2 steps on ETDRS retinopathy severity eye scale for participants with 1 eye less than PDR at baseline OR application of panretinal laser therapy. Participants were assigned at baseline to ETDRS retinopathy severity scale for persons or individual eyes; determination of no progression/progression was dependent on the scale.
Measured: Baseline through 36 Months
Change From Baseline in Estimated Glomerular Filtration Rate
The Modification of Diet in Renal Disease (MDRD) study formula used for the estimated glomerular filtration rate (eGFR) determination is: eGFR = 170 X (Serum creatinine concentration [mg/deciliter (dL)])-0.999 X (Age [years]) -0.176 X (0.762 if participant is female) X (1.180 if participant is black) X (Serum urea nitrogen concentration [mg/dL])-0.170 X (Serum albumin concentration [grams (g)/dL])+0.318.
Measured: Baseline, 36 Months
Change From Baseline at Endpoint in Albumin/Creatinine Ratio
Measured: 36 Months
Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months
25 vision-targeted questions representing 11 vision-related constructs and a 1-item general health rating question. Measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning and task-oriented domains related to daily visual functioning. Each item is converted to a 0 to 100 scale such that a higher score represents better functioning.
Measured: 36 Months
Number of Participants With Adverse Events
Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Measured: Baseline through 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2004 (estimated)
- Study startFeb 2004
- Primary completionApr 2010
- Study completionApr 2010
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chromaderm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karl Beutner, Study director, Chromaderm, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090519
- Sponsor's protocol ID
- 8211
- Other IDs
- B7A-MC-MBDL
- Status last verified
- Aug 2016
- First submitted
- 26 Aug 2004
- Last updated
- 6 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
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
- Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00090519
- Acronym / sponsor ID
- 8211
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Chromaderm, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 31 Aug 2004 (estimated)
- Results
- Posted 16 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruboxistaurin | Experimental | Drug: ruboxistaurin32 milligrams (mg) once daily (QD) oral for up to 36 months |
| Placebo | Placebo comparator | Drug: placeboQD oral for up to 36 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 Type 2 diabetes
- 18 years or older
- Non-clinically significant diabetic macular edema
- Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye
- Relatively good vision (20/30 or better)
Key exclusion criteria (4 listed)
- Surgery or laser treatment in the study eye
- Glaucoma in the study eye
- Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
- Liver disease, dialysis or renal transplant
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: LY333531, Arxxant32 mg once daily (QD) oral for up to 36 months | Drug | Ruboxistaurin |
| placeboQD oral for up to 36 months | Drug | Placebo |
Primary outcome
Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME)
Time frame: 6 Months through 36 Months
Duration of center of macula involvement when primary study outcome (DME involvement in center of macula determined by central grading of stereoscopic fundus photographs) was identified at a visit, participant was considered to have had definite center involvement for a specified length of time between the adjacent visits. Total duration of center involvement was calculated. Mean duration was total duration of center involvement divided by total number of participants. Participant durations were summarized, total number of months of center involvement in both treatment groups were displayed.
Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye
Time frame: Baseline, 36 Months
The occurrence of SMVL was defined as ≥15 letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) in any DR study eye relative to baseline that is sustained for the last 6 months of participation. ETDRS VA: participant starts at the top of the chart containing 5 letters per row and reads down the chart until reaching a row where a minimum of 3 letters on a line cannot be read. Participant is scored by how many letters could be correctly identified. A higher number of letters correctly identified represents better visual acuity.
8 secondary outcomes
Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months
Time frame: Baseline, 36 Months
First Occurrence of Focal/Grid Photocoagulation
Time frame: Baseline through 36 Months
Change From Baseline in Contrast Sensitivity by Pelli-Robson
Time frame: Baseline, 36 Months
Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography
Time frame: Baseline through 36 Months
Change From Baseline in Estimated Glomerular Filtration Rate
Time frame: Baseline, 36 Months
Change From Baseline at Endpoint in Albumin/Creatinine Ratio
Time frame: 36 Months
Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months
Time frame: 36 Months
Number of Participants With Adverse Events
Time frame: Baseline through 36 Months
Results and safety
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.
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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.
84 sites in 17 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 Retinopathy, run by Chromaderm, Inc. at 84 sites in 17 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 4 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 84 sites in United States, Canada, Australia, United Kingdom, Germany and 12 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 16 May 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?
Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) (time frame: 6 Months through 36 Months). The study lists 2 primary outcomes in all. 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 NCT00090519, 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.