No abstract

The aim of this study was to determine the specificity and sensitivity of transcranial sonography (TCS) and the Pocket Smell Test (PST) in differing Parkinson's disease from essential tremor. The results were compared with the dopamin transporter scan (DaTSCAN) findings. Based on the DaTSCAN finding we formed a group of patients with essential tremor (51 patients) and a group with the Parkinson's disease (59 patients). The control group consisted of 26 healthy one. To evaluate the olfactory dysfunction the PST was used, whereas by TCS the substantia nigra hyperechogenicity was marked. The sensitivity and specificity of each diagnostic method was statistically calculated. In confirming Parkinson's disease the specificity of TCS was 88.2 % and the sensitivity 94.9 %. The specificity of PST was 80.4 % whereas the sensitivity was 74.6 %. TCS and PST should be performed to evaluate which patients need to be examined by DaTSCAN.

The aim of this study was to determine the specificity and sensitivity of the Pelli-Robson and Ishihara diagnostic methods in differing Parkinson's disease from essential tremor compared to DaTSCAN (dopamine transporter scan) findings. The intention was to investigate whether visual dysfunction appears in the early state of Parkinson's disease. Therefore, we included patients with the symptomatology of parkinsonism lasting between 6 and 12 months. The study included 164 patients of which 59 (36.0%) suffered from Parkinson's disease, 51 (31.1%) from essential tremor, and 54 (32.9%) healthy patients which presented the control group. The specificity of Pelli-Robson test in confirming Parkinson's disease was 53% and the sensitivity 81.4%. The specificity of Ishihara test in confirming Parkinson's disease was 88.2%, and sensitivity 55.9%. We found that the colour and contrast dysfunction are present as the earliest symptoms of Parkinson's disease. In this study the Pelli-Robson test is highly sensitive and the Ishihara tables are highly specific in the differential diagnosis between Parkinson's disease and essential tremor, but neither of these methods fulfils the criteria for the validity of a test. We suggest performing both of these methods to evaluate which patients are indicated for DaTSCAN.

ImportanceAflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy.ObjectiveTo establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD).Design, Setting, and ParticipantsThis was a randomized double-masked parallel group phase 3 trial conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up.InterventionParticipants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56.Main Outcomes and MeasuresThe primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of −3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity.ResultsThe mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, −1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, −110.4 μm vs AFL, −115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable.Conclusions and RelevanceIn this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD.Trial RegistrationClinicalTrials.gov Identifier: NCT04450329

No abstract