ECGs were also performed 1 month postrandomization. Physical examinations and electrocardiograms (ECGs) were performed at screening and every 6 months thereafter. Laboratory evaluations were performed at each visit. The Medical Dictionary for Regulatory Activities (MedDRA) was used to categorize reported adverse events. Adverse events that resulted in death, hospitalization, cancer, permanent disability, or threat to life were classified as serious. The development and progression of DR is related to blood glucose concentration and is slowed by intensive glycemic control ( 6, 7).Īll serious and nonserious adverse events were analyzed regardless of the investigators’ assessments of causality. DME is a leading cause of moderate visual loss (MVL) in diabetes ( 5) and is often also treated with laser. In addition, retinal vessels can become permeable and cause swelling of the retina, called diabetic macular edema (DME). PDR accounts for the majority of severe visual loss and is generally treated with laser panretinal photocoagulation (PRP). DR can progress to a stage called proliferative diabetic retinopathy (PDR), where new vessels proliferate on the retina. Visual loss from diabetes results primarily from two ocular complications. Despite the availability of laser photocoagulation and improved control of hyperglycemia and other risk factors, diabetes remains a leading cause of visual loss in working-age adults ( 4). Diabetic retinopathy (DR) is the most prevalent diabetic microvascular complication, being present in nearly 50% of the diabetic population at any time and eventually occurring in nearly all patients with diabetes ( 2, 3). In this clinical trial, RBX was well tolerated and reduced the risk of visual loss but did not prevent DR progression.ĭiabetes is estimated to affect over 18 million Americans and is increasing rapidly in the U.S. In multivariable Cox proportional hazard analysis, 32 mg/day RBX significantly reduced the risk of MVL compared with placebo (hazard ratio 0.37, P = 0.012). RBX reduction of SMVL was evident only in eyes with definite diabetic macular edema at baseline (10% 32 mg/day RBX vs. Compared with placebo, 32 mg/day RBX was associated with a delayed occurrence of MVL (log rank, P = 0.038) and of SMVL ( P = 0.226). RBX was well tolerated without significant adverse effects but had no significant effect on the progression of DR. Efficacy measures included progression of DR, moderate visual loss (MVL) (doubling of the visual angle), and sustained MVL (SMVL). Patients had an Early Treatment Diabetic Retinopathy Study (ETDRS) retinopathy severity level between 47B and 53E inclusive, an ETDRS visual acuity of 20/125 or better, and no history of scatter (panretinal) photocoagulation. In this multicenter, double-masked, randomized, placebo-controlled study, 252 subjects received placebo or RBX (8, 16, or 32 mg/day) for 36–46 months. In so doing, an ophthalmologist prescribes vision services, including glasses and contact lenses.The purpose of this study was to evaluate the Safety and efficacy of the orally administered protein kinase C (PKC) β isoform-selective inhibitor ruboxistaurin (RBX) in subjects with moderately severe to very severe nonproliferative diabetic retinopathy (NPDR). This includes problems affecting the eye and its component structures, the eyelids, the orbit and the visual pathways. Ophthalmologists are medically trained to diagnose, monitor and medically or surgically treat all ocular and visual disorders. Practices include eye exams, blepharoplasty, intraoccular lens, laser eye surgery, and photodynamic therapy.Īn ophthalmologist has the knowledge and professional skills needed to provide comprehensive eye and vision care. Medical tests, procedures and therapies provided by Ophthalmology Ophthalmology practices include amblyopia (lazy eye), astigmatism, cataracts, conjunctivitis, diabetic retinopathy, dry eye, eye cancer, glaucoma, hyperopia, macular degeneration, myopia, presbyopia, retinal detachment, strabismus, and uveitis. Significant diseases and conditions treated at The diagnosis and treatment of all eye and visual ailments including vision services (glasses and contacts) and surgery, as well as the prevention of medical eye disorders. Ophthalmologists at Intermountain Eye And Laser Centers, PLLC performĮye exams, vision care, eye disease diagnosis and treatment, and eye surgery. With healthcare providers who have special training and skill in performing eye exams, diagnosing and treating eye disease, prescribing medications and performing eye surgery. Intermountain Eye And Laser Centers, PLLC is an Ophthalmology practice in Boise, ID
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