At a glance
ClinicalIndex Comparison Record- ✓Type 1 or Type 2 diabetes mellitus
- ✓Age 18 years or older
- ✓Hemoglobin A1c ≤11%
- ✓Mild to very severe non-proliferative diabetic retinopathy in study eye
- ✕Prior intraocular surgery or laser treatment in study eye, or anticipated need for laser within 3 months
- ✕Glaucoma in study eye
- ✕Unstable cardiovascular disease
- ✕Major surgery within past 3 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema
In Brief
A Phase 3 clinical trial evaluating Ruboxistaurin and Placebo for Diabetic Macular Edema. Completed, enrolled 309 participants across 41 sites in 10 countries.
Detailed Summary
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (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.
Study Details
Timeline
Interventions
Administered orally
Administered orally