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Treatment for Completers of the Study B7A-MC-MBCM

Sponsor
Chromaderm, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00266695
Collaborator
(none)
203
Enrollment
29
Locations
1
Arm
31
Duration (Months)
7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
203 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open-Label Treatment for Patients Completing Study B7A-MC-MBCM
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
Aug 1, 2008
Actual Study Completion Date :
Aug 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ruboxistaurin

Drug: Ruboxistaurin
32-milligram (mg) tablet, orally, once daily (QD) for up to 2 years.
Other Names:
  • LY 333531
  • Arxxant

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Sustained Moderate Visual Loss (SMVL) [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).

    Secondary Outcome Measures

    1. Vision Loss [End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months]

      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).

    2. 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)]

      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).

    3. 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]

      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.

    4. Visual Acuity [Month 24]

      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.

    5. Number of Participants Receiving Treatment With Focal/Grid Photocoagulation [Baseline up to Month 24]

    6. Number of Participants Receiving Treatment With Panretinal Photocoagulation [Baseline up to Month 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients that completed Month 36 (Visit 15) of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment.
    Exclusion Criteria:
    • Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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 United States 85210
    2 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 Phoenix Arizona United States 85014
    3 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 Huntington Beach California United States 92647
    4 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 Orange California United States 92868
    5 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 Sacramento California United States 95817
    6 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 Hamden Connecticut United States 06518
    7 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 Newark Delaware United States 19713
    8 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 Tampa Florida United States 33609
    9 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 Honolulu Hawaii United States 96813
    10 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 Wheaton Illinois United States 60187
    11 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 Indianapolis Indiana United States 46280
    12 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 Shawnee Mission Kansas United States 66204
    13 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 United States 21287
    14 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 Towson Maryland United States 21204
    15 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 Boston Massachusetts United States 02215
    16 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 Grand Rapids Michigan United States 49525
    17 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 Royal Oak Michigan United States 48073
    18 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 Columbia Missouri United States 65212
    19 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 Staten Island New York United States 10305
    20 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 Charlotte North Carolina United States 28210
    21 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 Beachwood Ohio United States 44122
    22 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 Cincinnati Ohio United States 45242
    23 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 Hershey Pennsylvania United States 17033
    24 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 Pittsburgh Pennsylvania United States 15213
    25 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 Columbia South Carolina United States 29203
    26 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 Rapid City South Dakota United States 57701
    27 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 Dallas Texas United States 75231
    28 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 Salt Lake City Utah United States 84107
    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 Madison Wisconsin United States 53705

    Sponsors and Collaborators

    • Chromaderm, Inc.

    Investigators

    • Study Director: Karl Beutner, Chromaderm, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Chromaderm, Inc.
    ClinicalTrials.gov Identifier:
    NCT00266695
    Other Study ID Numbers:
    • 10699
    • B7A-MC-MBDV
    First Posted:
    Dec 19, 2005
    Last Update Posted:
    Oct 6, 2016
    Last Verified:
    Aug 1, 2016
    Additional relevant MeSH terms:
    Diabetic Retinopathy
    Ruboxistaurin

    Study Results

    Participant Flow

    Recruitment Details This study, B7A-MC-MBDV (MBDV), was an open-label extension of Study B7A-MC-MBCM (MBCM; NCT00604383), and was only open to participants who completed Study MBCM. Unless otherwise stated, the time frames refer to this study, MBDV.
    Pre-assignment Detail
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 milligrams (mg) given once daily as an oral tablet for 2 years.
    Period Title: Overall Study
    STARTED 203
    COMPLETED 174
    NOT COMPLETED 29

    Baseline Characteristics

    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    Overall Participants 203
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    58.50
    (9.70)
    Sex: Female, Male (Count of Participants)
    Female
    70
    34.5%
    Male
    133
    65.5%
    Race/Ethnicity, Customized (participants) [Number]
    Caucasian
    180
    88.7%
    Non-Caucasian
    23
    11.3%
    Region of Enrollment (participants) [Number]
    United States
    203
    100%
    Diabetes Type (participants) [Number]
    Type 1
    24
    11.8%
    Type 2
    179
    88.2%
    Duration of Diabetes (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    16.08
    (8.40)
    Body Mass Index (kilograms per square meter (kg/m^2)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilograms per square meter (kg/m^2)]
    33.47
    (7.34)
    Number of Diabetic Retinopathy (DR) Study Eyes Per Participant (participant) [Number]
    One
    72
    Two
    131
    Visual Acuity (VA) Score (letters read correctly) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [letters read correctly]
    76.84
    (13.11)
    Blood Pressure (millimeters of mercury (mm Hg)) [Mean (Standard Deviation) ]
    Systolic Blood Pressure
    131.48
    (17.03)
    Diastolic Blood Pressure
    73.29
    (10.07)

    Outcome Measures

    1. Primary Outcome
    Title Sustained Moderate Visual Loss (SMVL)
    Description 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).
    Time Frame Baseline, 18 months up to 24 months

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants.
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    Measure Participants 203
    Number [participants]
    10
    4.9%
    2. Secondary Outcome
    Title Vision Loss
    Description 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).
    Time Frame End of Study MBCM to the beginning of Study MBDV, approximately 6 to 18 months

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants.
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    Measure Participants 203
    Number [participants]
    22
    10.8%
    3. Secondary Outcome
    Title Sustained Moderate Vision Loss (SMVL), Long Term
    Description 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).
    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)

    Outcome Measure Data

    Analysis Population Description
    Participants who were treated with 32 milligram (mg) ruboxistaurin once daily in Study MBCM and had at least 1 DR study eye, who were also enrolled in Study MBDV.
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    Measure Participants 103
    Number [participants]
    8
    3.9%
    4. Secondary Outcome
    Title Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants (pts) at risk during the specified intervals. Pts who did not experience an event during the interval were censored to the last time point in the interval. Number of pts censored: 0 to 6 months = 2 pts, 6 to 12 months = 4 pts, 12 to 18 months = 9 pts, 18 to 24 months = 82 pts, and 24 to 30 months = 90 pts.
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    Measure Participants 198
    0 up to 6 months, n=198
    0
    0%
    6 up to 12 months, n=196
    4
    2%
    12 up to 18 months, n=188
    5
    2.5%
    18 up to 24 months, n=174
    2
    1%
    24 up to 30 months, n=90
    0
    0%
    5. Secondary Outcome
    Title Visual Acuity
    Description 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.
    Time Frame Month 24

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants. Last observation carried forward (LOCF).
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    Measure Participants 203
    Mean (Standard Deviation) [letters read correctly]
    75.14
    (14.92)
    6. Secondary Outcome
    Title Number of Participants Receiving Treatment With Focal/Grid Photocoagulation
    Description
    Time Frame Baseline up to Month 24

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants.
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    Measure Participants 203
    Number [participants]
    19
    9.4%
    7. Secondary Outcome
    Title Number of Participants Receiving Treatment With Panretinal Photocoagulation
    Description
    Time Frame Baseline up to Month 24

    Outcome Measure Data

    Analysis Population Description
    All enrolled participants.
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    Measure Participants 203
    Number [participants]
    53
    26.1%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Ruboxistaurin
    Arm/Group Description 32 mg given once daily as oral tablet for 2 years.
    All Cause Mortality
    Ruboxistaurin
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Ruboxistaurin
    Affected / at Risk (%) # Events
    Total 57/203 (28.1%)
    Blood and lymphatic system disorders
    Anaemia 1/203 (0.5%) 1
    Cardiac disorders
    Acute myocardial infarction 1/203 (0.5%) 1
    Atrial fibrillation 1/203 (0.5%) 1
    Bradycardia 1/203 (0.5%) 1
    Cardiac arrest 1/203 (0.5%) 2
    Cardiac failure congestive 8/203 (3.9%) 15
    Cardio-respiratory arrest 1/203 (0.5%) 1
    Cardiopulmonary failure 1/203 (0.5%) 1
    Coronary artery disease 6/203 (3%) 6
    Hypertensive heart disease 1/203 (0.5%) 1
    Ischaemic cardiomyopathy 1/203 (0.5%) 1
    Myocardial infarction 2/203 (1%) 2
    Sick sinus syndrome 1/203 (0.5%) 1
    Ventricular dysfunction 1/203 (0.5%) 1
    Ventricular tachycardia 1/203 (0.5%) 1
    Gastrointestinal disorders
    Acute abdomen 1/203 (0.5%) 1
    Erosive oesophagitis 1/203 (0.5%) 1
    Gastric ulcer 1/203 (0.5%) 1
    Gastritis 1/203 (0.5%) 1
    Gastritis erosive 1/203 (0.5%) 1
    Impaired gastric emptying 1/203 (0.5%) 1
    Intestinal obstruction 2/203 (1%) 2
    Nausea 1/203 (0.5%) 1
    Oesophagitis 1/203 (0.5%) 1
    Upper gastrointestinal haemorrhage 1/203 (0.5%) 1
    Vomiting 1/203 (0.5%) 1
    General disorders
    Chest pain 4/203 (2%) 4
    Death 1/203 (0.5%) 1
    Generalised oedema 1/203 (0.5%) 1
    Oedema peripheral 1/203 (0.5%) 1
    Infections and infestations
    Appendicitis 1/203 (0.5%) 1
    Arthritis infective 1/203 (0.5%) 1
    Bronchitis 1/203 (0.5%) 1
    Cellulitis 7/203 (3.4%) 8
    Endocarditis 1/203 (0.5%) 1
    Gangrene 1/203 (0.5%) 1
    Gastroenteritis 1/203 (0.5%) 1
    Gastroenteritis viral 1/203 (0.5%) 1
    Infection 1/203 (0.5%) 1
    Kidney infection 1/203 (0.5%) 1
    Localised infection 1/203 (0.5%) 1
    Osteomyelitis 4/203 (2%) 4
    Pneumonia 4/203 (2%) 4
    Pyelonephritis acute 1/203 (0.5%) 1
    Septic shock 1/203 (0.5%) 1
    Sinusitis 1/203 (0.5%) 1
    Staphylococcal abscess 1/203 (0.5%) 1
    Staphylococcal bacteraemia 1/203 (0.5%) 1
    Urinary tract infection 3/203 (1.5%) 3
    Urosepsis 1/203 (0.5%) 1
    Viral infection 1/203 (0.5%) 1
    Wound infection staphylococcal 1/203 (0.5%) 1
    Injury, poisoning and procedural complications
    Acetabulum fracture 1/203 (0.5%) 1
    Foot fracture 1/203 (0.5%) 1
    Hip fracture 1/203 (0.5%) 1
    Lower limb fracture 1/203 (0.5%) 1
    Pocket erosion 1/203 (0.5%) 1
    Rib fracture 1/203 (0.5%) 1
    Subdural haematoma 1/203 (0.5%) 1
    Investigations
    Heart rate irregular 2/203 (1%) 2
    Metabolism and nutrition disorders
    Dehydration 3/203 (1.5%) 3
    Diabetes mellitus inadequate control 1/203 (0.5%) 1
    Hyperglycaemia 1/203 (0.5%) 1
    Hypoglycaemia 1/203 (0.5%) 1
    Hypokalaemia 1/203 (0.5%) 1
    Type 2 diabetes mellitus 1/203 (0.5%) 1
    Musculoskeletal and connective tissue disorders
    Fistula 1/203 (0.5%) 1
    Pain in extremity 1/203 (0.5%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphoma 1/203 (0.5%) 1
    Thyroid cancer 1/203 (0.5%) 1
    Nervous system disorders
    Brain stem infarction 1/203 (0.5%) 1
    Carotid artery occlusion 1/203 (0.5%) 1
    Cerebrovascular accident 1/203 (0.5%) 1
    Cervicobrachial syndrome 1/203 (0.5%) 1
    Coma 1/203 (0.5%) 1
    Dizziness 1/203 (0.5%) 1
    Syncope 3/203 (1.5%) 3
    Transient ischaemic attack 2/203 (1%) 2
    Renal and urinary disorders
    Diabetic nephropathy 1/203 (0.5%) 1
    Renal failure acute 6/203 (3%) 6
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/203 (0.5%) 1
    Chronic obstructive pulmonary disease 1/203 (0.5%) 2
    Dyspnoea 3/203 (1.5%) 3
    Epistaxis 1/203 (0.5%) 1
    Interstitial lung disease 1/203 (0.5%) 1
    Pleural effusion 1/203 (0.5%) 1
    Pneumonia aspiration 1/203 (0.5%) 1
    Pulmonary oedema 1/203 (0.5%) 1
    Respiratory failure 3/203 (1.5%) 4
    Skin and subcutaneous tissue disorders
    Hyperhidrosis 1/203 (0.5%) 1
    Surgical and medical procedures
    Toe amputation 1/203 (0.5%) 1
    Vascular disorders
    Arteriosclerosis 1/203 (0.5%) 1
    Hypertensive emergency 1/203 (0.5%) 1
    Hypotension 2/203 (1%) 2
    Malignant hypertension 1/203 (0.5%) 1
    Orthostatic hypotension 1/203 (0.5%) 1
    Peripheral vascular disorder 1/203 (0.5%) 1
    Other (Not Including Serious) Adverse Events
    Ruboxistaurin
    Affected / at Risk (%) # Events
    Total 166/203 (81.8%)
    Eye disorders
    Vitreous haemorrhage 20/203 (9.9%) 25
    Gastrointestinal disorders
    Diarrhoea 16/203 (7.9%) 19
    Infections and infestations
    Bronchitis 12/203 (5.9%) 14
    Nasopharyngitis 22/203 (10.8%) 32
    Upper respiratory tract infection 11/203 (5.4%) 11
    Urinary tract infection 13/203 (6.4%) 21
    Musculoskeletal and connective tissue disorders
    Back pain 18/203 (8.9%) 20
    Respiratory, thoracic and mediastinal disorders
    Cough 15/203 (7.4%) 19
    Surgical and medical procedures
    Cataract operation 15/203 (7.4%) 20
    Retinal laser coagulation 49/203 (24.1%) 111
    Vitrectomy 12/203 (5.9%) 16

    Limitations/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.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title info@chroma-derm.com
    Organization Chromaderm
    Phone info@chroma-derm.com
    Email
    Responsible Party:
    Chromaderm, Inc.
    ClinicalTrials.gov Identifier:
    NCT00266695
    Other Study ID Numbers:
    • 10699
    • B7A-MC-MBDV
    First Posted:
    Dec 19, 2005
    Last Update Posted:
    Oct 6, 2016
    Last Verified:
    Aug 1, 2016