Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chromaderm, Inc.
ClinicalTrials.gov Identifier:
NCT00090519
First received: August 26, 2004
Last updated: July 25, 2016
Last verified: July 2016

August 26, 2004
July 25, 2016
February 2004
April 2010   (final data collection date for primary outcome measure)
  • Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) [ Time Frame: 6 Months through 36 Months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Complete list of historical versions of study NCT00090519 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
    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.
  • First Occurrence of Focal/Grid Photocoagulation [ Time Frame: Baseline through 36 Months ] [ Designated as safety issue: No ]
    The first occurrence of focal/grid photocoagulation regardless of diabetic macular edema (DME) distance from the center of the macula.
  • Change From Baseline in Contrast Sensitivity by Pelli-Robson [ Time Frame: Baseline, 36 Months ] [ Designated as safety issue: No ]
    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.
  • Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography [ Time Frame: Baseline through 36 Months ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Estimated Glomerular Filtration Rate [ Time Frame: Baseline, 36 Months ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline at Endpoint in Albumin/Creatinine Ratio [ Time Frame: 36 Months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Number of Participants With Adverse Events [ Time Frame: Baseline through 36 Months ] [ Designated as safety issue: Yes ]
    Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
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Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Diabetic Retinopathy
  • Drug: ruboxistaurin
    32 mg once daily (QD) oral for up to 36 months
    Other Names:
    • LY333531
    • Arxxant
  • Drug: placebo
    QD oral for up to 36 months
  • Experimental: Ruboxistaurin
    32 milligrams (mg) once daily (QD) oral for up to 36 months
    Intervention: Drug: ruboxistaurin
  • Placebo Comparator: Placebo
    QD oral for up to 36 months
    Intervention: Drug: placebo
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 β 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
731
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Brazil,   Canada,   Denmark,   France,   Germany,   India,   Italy,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Taiwan,   United Kingdom
 
NCT00090519
8211, B7A-MC-MBDL
No
Not Provided
Not Provided
Chromaderm, Inc.
Chromaderm, Inc.
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Chromaderm, Inc.
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP