Diabetic Macular Edema (DME), is the most common cause of visual impairment in patients with diabetic retinopathy (DR). It is the accumulation of extracellular fluid in the retinal tissues of the macula and is a microvascular complication of diabetes. In this study patients will have macular edema that meets the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant macular edema (CSME), (but patients with imminently vision threatening macular edema are excluded).
Conditions
Interventions
Product Name: Ruboxistaurin
Product Code: LY333531
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Ruboxistaurin
CAS Number: 169
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Have type 1 or type 2 diabetes mellitus as defined by American Diabetes Association (ADA) and World Health Organization (WHO) criteria. - Have DME (based on 7-field stereoscopic fundus photogrpahs confirmed by the Fundus Photograph Reading Center) at Visit 1, showing in the study eye: [A] Any photographically detectable retinal thickening at or between 100 and 500 microns from the center of the macula. or [B] Retinal thickening >= 1 disc area in size, any part of which is within 100 microns from the center of the macula, or [C] Both [A] and [B]. BUT EXCLUDING Retinal thickening, or hard exudates associated with adjacent retinal thickening, leass than 100 microns from the center of the macula, as noted on stereo fundus photographs. - Have, in the study eye, a DR level corresponding to ETDRS retinopathy score >=35b and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Retinal thickening, or hard exudates associated with adjacent retinal thickening, less than 100 microns from the center of the macula, noted on stereo fundus photographs in the study eye at Visit 1. - Have had previous photocoagulation for DR and/or DME in the study eye prior to Visit 1. - Are likely to require focal/grid or pan-retinal (scatter) photocoagulation in the study eye within 3 months of study randomization, in the opinion of the investigator, at Visit 1. - Have tractional DME, thickened taut posterior hyaloid membrane, or cystoid changes in the study eye, in the opinion of the investigator, as determined by OCT. - Have had intra-ocular surgery, e.g. cataract extraction, within 6 months of visit 1, and/or anticipated intra-ocular surgery during the study, in the opinion of the investigator, in the study eye. - Have an occludable anterior chamber angle or open angle glaucoma in the study eye, in the opinion of the investigator, at Visit 1. Ocular hypertension in the absence of a glaucomatous visual field defect is not an exclusion criterion. - Have current vitreous or pre-retinal hemorrhage in the study eye at Visit 1. - Have eccentric or imperfect fixation in the study eye at Visit 1. - Have a history of conditions in the study eye at Visit 1 which, in the opinion of the investigator, might affect macular edema, alter visual acuity, or confound stereoscopic fundus photography or OCT readings, including but not limited to: intra-ocular surgery, significant chorioretinal scars, optic atrophy, retinal degeneration, retinal vein occlusion, retinal artery occlusion, rubeosis iridis, pathologic myopia, age-related macular degeneration, posterior uveitis, branch vein or artery occlusion. - Are unable to provide adequate OCT readings or fundus photography at Visit 1 ( as assessed by the reading center) for reasons including but not limited to: media opacity or compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy measure is the change from baseline to endpoint in absolute retinal thickness at the center of the macula, as determined by OCT. ;Main Objective: To test the hypothesis that oral administration of 32 mg per day of ruboxistaurin for approximately 24 months will reduce, relative to placebo, the baseline to endpoint changes in central macular thickness, as measured by OCT, in patients with CSME, not within 100 microns from the center of the macula at baseline.; Secondary Objective: Key secondary objective: - Occurrence of sustained moderate visual loss (SMVL, defined as a 15 letter or more decrease from baseline in best-corrected 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. Additional secondary objectives: - Change from baseline to endpoint in mean retinal thickness within 500 microns of the center of the macula, as assessed by OCT. - Incidence and time to occurrence of significant center-involved macular edema, as assessed by OCT. - Change from baseline or time to occurrence in any other appropriate measures or treatments of DME or visual function, including but not limited to: photocoagulation, contrast sensitivity, and macular edema volume measures. - Safety and Tolerability | — |
Countries
Denmark, Germany, Lithuania, Spain, United Kingdom
Outcome results
None listed