Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
|ClinicalTrials.gov Identifier: NCT00090519|
Recruitment Status : Completed
First Posted : August 31, 2004
Results First Posted : May 16, 2016
Last Update Posted : October 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Drug: ruboxistaurin Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||731 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Reduction in the Occurrence of Center-Involved Diabetic Macular Edema|
|Study Start Date :||February 2004|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
32 milligrams (mg) once daily (QD) oral for up to 36 months
32 mg once daily (QD) oral for up to 36 months
Placebo Comparator: Placebo
QD oral for up to 36 months
QD oral for up to 36 months
- 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.
- 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 ]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 ]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 ]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 ]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 ]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 ]
- 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 ]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 ]Summaries of serious adverse events (SAEs) and all other non-serious adverse events (AEs) are located in the Reported Adverse Event Module.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00090519
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|Study Director:||Karl Beutner||Chromaderm, Inc.|