IMPORTANCEThe outcomes of vismodegib treatment in a relatively large cohort of study participants with periocular locally advanced basal cell carcinoma (POLA-BCC) may guide physicians when considering this treatment.OBJECTIVE To report the outcomes of vismodegib treatment in patients with POLA-BCC in the Safety Events in Vismodegib (STEVIE) study. DESIGN, SETTING, AND PARTICIPANTSThis post hoc subgroup analysis from the STEVIE single-arm, multicenter, open-label cohort study screened all 1215 participants for ocular or periocular involvement and identified 244 participants with POLA-BCC or metastatic BCC. Data for the first STEVIE trial were collected from 167 treatment locations in 36 countries from June 30, 2011, to June 14, 2017. This post hoc analysis was performed from April 1 to August 31, 2019. MAIN OUTCOMES AND MEASURESResponse to treatment and adverse events. RESULTS Ocular or periocular involvement was found in 244 of 1215 STEVIE participants (20.1%), who constituted the analytic sample. The median age of the study participants was 72.0 (interquartile range [IQR], 60.0-82.0]) years, and they included 143 men (58.6%). Locally advanced BCC was diagnosed in 238 of the 244 participants (97.5%) and metastatic BCC, in 6 (2.5%). The median duration of exposure to vismodegib was 40.0 (IQR, 20.0-78.0) weeks, specifically 39.7 (IQR, 19.9-76.0) weeks for POLA-BCC and 92.4 (IQR, 53.2-163.0) weeks for metastatic BCC. Sixty-nine participants (28.3%) sustained serious adverse events (alopecia, muscle spasms, dysgeusia, weight loss, decreased appetite, asthenia, ageusia, nausea, fatigue, and diarrhea). Two hundred thirty-two study participants (95.1%) sustained more than 1 adverse effect. The overall mean (SD) number of drug-related adverse effects per study participant by first adverse event, regardless of the severity, was 5.48 (3.84). Discontinuation of vismodegib treatment owing to an adverse event was recorded in 58 participants (23.8%). During the study, 22 participants (9.0%) died, 70 (28.7%) achieved complete response, and 94 (38.5%) achieved partial response. CONCLUSIONS AND RELEVANCEVismodegib was well tolerated by the study participants with POLA-BCC. The safety of vismodegib treatment according to the STEVIE trial findings is consistent with that reported in previous studies. These data may be helpful when considering vismodegib for patients with POLA-BCC.

Introduction. To compare the safety and efficacy of the Therapeutic Hyper-CL™ lens versus a standard bandage contact lens (PureVision B&L) for chronic corneal edema. Methods. Prospective, multicenter, randomized, crossover study. Chronic corneal edema patients were randomized to one of two arms. The first arm was fitted with the Therapeutic Hyper-CL™ lens while the second arm was fitted with a standard soft bandage contact lens. Both arms were treated with 5% sodium chloride 6 times a day. After a 7-day treatment period, there was a 7-day washout period, after which the arms were crossed over. Patients were evaluated at days 0 (baseline), 7 (following first treatment allocation), 14 (following washout), and 21 (following second treatment allocation). The primary outcomes were 3 lines of BCVA (best corrected visual acuity) improvement. Results. In total, 49 patients were enrolled. There was significantly greater BCVA improvement rate >3 lines (30.4% versus 17.4%, P=0.04) in the Therapeutic Hyper-CL™ lens group. The mean change in BCVA lines was significantly greater for the Therapeutic Hyper-CL™ lens (3.4 ± 6.7 versus 0.9 ± 2.3, P=0.02). Conclusions. The Therapeutic Hyper-CL™ lens was associated with a higher chance for significant visual acuity improvement when compared to a standard bandage contact lens combined with 5% sodium chloride. This trial is registered with NCT02660151.

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Purpose: To evaluate the effect of a single subconjunctival aflibercept injection on formed corneal neovascularization. Methods: A prospective clinical trial, conducted at a single tertiary medical center. Included were consecutive patients with corneal pathologies complicated by corneal neovascularization, who were candidates for anti–vascular endothelial growth factor treatment at the discretion of a cornea specialist. A single subconjunctival injection of 0.08 mL of Aflibercept (Eylea 25 mg/mL) was administered near the limbus in proximity to the areas of maximal pathological neovascularization. Follow-up visits were scheduled on days 7, 30, 60, and 90 following injection. Best-corrected visual acuity (BCVA), intraocular pressure, slitlamp examination, digital cornea photography, specular microscopy, and anterior-segment optical coherence tomography were documented at each visit. The images were graded by a masked observer for density, extent, and centricity of corneal vascularization. Results: Six eyes of six patients were analyzed. No clinically significant ocular or systemic adverse events were documented. No change was noted in extent, density, or centricity of corneal blood vessels at seven, 30, and 90 days after injection (P>0.1 for all time point comparisons, Friedman test). Best-corrected visual acuity fluctuated insignificantly in 5/6 patients during follow-up time, and objective but not subjective improvement of BCVA was noted in one patient with no concurrent change of neovascularization. The recruitment has therefore halted prematurely. Conclusions: A single subconjunctival aflibercept injection seems to be well tolerated. However, it is ineffective for regressing formed corneal neovascularization.