Retina Today - Retina News (October 2016)

摘要

Combination Therapy Shows No Benefit Over Aflibercept Alone in Phase 2 AMD Trial The phase 2 CAPELLA study evaluating aflibercept (Eylea, Regeneron) coformulated with rinucumab (Regeneron), an anti–platelet-derived growth factor (anti-PDGF) receptor beta antibody, in patients with neovascular age-related macular degeneration (AMD) failed to reach its primary endpoint, according to a company press release. At 12 weeks, the combination therapy did not demonstrate an improvement in BCVA compared with aflibercept monotherapy. The press release reported that patients in the combination therapy arms showed a 5.8-letter improvement in BCVA, compared with a 7.5-letter improvement in the monotherapy arm. The CAPELLA trial is an ongoing phase 2 double-masked, randomized, controlled, multiple-dose, regimen-ranging study that has enrolled approximately 500 patients with wet AMD. Researchers randomly assigned patients to one of three groups: Patients received fixed doses every 4 weeks of 2 mg aflibercept monotherapy, 2 mg aflibercept/1 mg rinucumab combination therapy, or 2 mg aflibercept/3 mg rinucumab combination therapy. At week 12, two of the three treatment groups were rerandomized, resulting in five total dosing groups in the second phase of the study. Researchers will again evaluate data at weeks 28 and 52. The company reported that combination therapy showed no benefit over monotherapy on anatomic endpoints including reduction in retinal thickness or resolution of subretinal hyperreflective material. Ocular adverse events at week 12 were more common in the combination therapy groups (23.5% and 20%) than in the monotherapy group (16%), according to the company. VISUAL 1 Study: Adalimumab Associated with Uveitis Improvements In patients with uveitis, adalimumab (Humira, AbbVie) was associated with lower risk of uveitic flare or visual impairment compared with placebo, according to a study published in the New England Journal of Medicine.1 VISUAL 1 was a multinational phase 3 trial in which patients with active noninfectious intermediate uveitis, posterior uveitis, or panuveitis despite having received prednisone treatment for 2 or more weeks were randomly assigned in a 1:1 ratio to receive adalimumab or placebo. All patients received a mandatory prednisone burst followed by tapering of prednisone over the course of 15 weeks. The median time to treatment failure was 24 weeks in the adalimumab group, compared with 13 weeks in the placebo group. Patients who received adalimumab were significantly less likely than those in the placebo group to experience treatment failure. The treatment group also showed significantly better changes in anterior chamber cell grade, vitreous haze grade, and BCVA compared with the placebo group. There were more adverse events and serious adverse events reported in the treatment group than in the placebo group. 1. Jaffe GJ, Dick AD, Brezin AP, et al. Adalimumab in patients with active noninfectious uveitis [published online ahead of print September 8, 2016]. N Engl J Med. Study: Link Between Cataract Surgery and AMD Uncertain in Asian Eye Study Researchers found no link between cataract surgery and development or progression of AMD in a population study in Asian eyes, except for an increased risk for AMD development in left eyes that may have been a chance finding, according to a study published in JAMA Ophthalmology.1 The researchers in this cross-sectional study used a multistage, probability-cluster survey sample to produce nationally representative estimates from 20,419 participants in the Korea National Health and Nutrition Examination Survey. Data from 2008 to 2012 on cataract status and AMD grade were analyzed. Data from 34,869 eyes were analyzed; right eyes and left eyes had cataract surgery at equal rates. Of the 1,056 right eyes and the 949 left eyes with any AMD, 167 right eyes (15.2%) and 147 left eyes (13.7%) had cataract surgery. The a