Ocriplasmin for the Treatment of Symptomatic Vitreomacular Adhesion/Traction

2015 ◽  
Vol 8 (1) ◽  
pp. 55 ◽  
Author(s):  
Baruch D Kuppermann ◽  
Keyword(s):  
Clinical Trial ◽  
Treatment Option ◽  
Case Reports ◽  
Clinical Trial Data ◽  
Phase Iii ◽  
Vitreomacular Adhesion ◽  
Additional Tool ◽  
Phase Iii Clinical Trials ◽  
New Treatment ◽  
Clinical Trial Program

Ocriplasmin has recently been introduced as a new treatment option for patients with symptomatic vitreomacular adhesion/vitreomacular traction (VMA/VMT). Understanding its potential as well as its limitations is crucial as it becomes an additional tool in the management of these diseases. In this article the overall efficacy and safety of ocriplasmin are reviewed, focusing on the results from the phase III clinical trials as well as recently published case reports and postmarketing data analysis. Efficacy data from ocriplasmin use in a clinical setting support the subanalysis of the phase III clinical trial data. This analysis demonstrated that certain baseline ocular characteristics, namely focal VMA, and absence of epiretinal membrane, are predictive of VMA resolution. Safety findings show that the overall percentage of patients experiencing adverse events during the clinical trial program was low in ocriplasmin-treated patients. Postmarketing surveillance data corroborate findings from the phase III trials, and provide additional insights into the characterization of the safety profile of this new treatment option.

scholarly journals Ocriplasmin for the Treatment of Symptomatic Vitreomacular Adhesion/Traction

2015 ◽  
Vol 09 (01) ◽  
pp. 70
Author(s):  
Baruch D Kuppermann ◽  
Keyword(s):  
Clinical Trial ◽  
Treatment Option ◽  
Case Reports ◽  
Clinical Trial Data ◽  
Phase Iii ◽  
Vitreomacular Adhesion ◽  
Additional Tool ◽  
Phase Iii Clinical Trials ◽  
New Treatment ◽  
Clinical Trial Program

Ocriplasmin has recently been introduced as a new treatment option for patients with symptomatic vitreomacular adhesion/vitreomacular traction (VMA/VMT). Understanding its potential as well as its limitations is crucial as it becomes an additional tool in the management of these diseases. In this article the overall efficacy and safety of ocriplasmin are reviewed, focusing on the results from the phase III clinical trials as well as recently published case reports and postmarketing data analysis. Efficacy data from ocriplasmin use in a clinical setting support the subanalysis of the phase III clinical trial data. This analysis demonstrated that certain baseline ocular characteristics, namely focal VMA, and absence of epiretinal membrane, are predictive of VMA resolution. Safety findings show that the overall percentage of patients experiencing adverse events during the clinical trial program was low in ocriplasmin-treated patients. Postmarketing surveillance data corroborate findings from the phase III trials, and provide additional insights into the characterization of the safety profile of this new treatment option.

Solithromycin as A Potential Novel Antibiotic Against Neisseria Gonorrhoeae Resistance

2020 ◽  
Author(s):  
Muhammad Habiburrahman ◽  
Vivian  Soetikno ◽  
Wani Riselia Sirait ◽  
Missy Savira
Keyword(s):  
Clinical Trial ◽  
Neisseria Gonorrhoeae ◽  
Wide Distribution ◽  
Phase Iii ◽  
Financial Loss ◽  
Anatomic Site ◽  
Transmitted Infection ◽  
Sexually Transmitted ◽  
Phase Iii Clinical Trials ◽  
New Treatment

Gonorrhea is one of the most often sexually transmitted infection in the world. In 2016, WHO stated the Southeast Asia region as the fourth-highest incidence rate and prevalence of gonorrhea. One of the current problems with gonorrhea is related to its emerging resistance to first-line drugs such as cephalosporins, macrolides, and fluoroquinolones. This resistance has an impact on the difficulty of finding effective antibiotics to eradicate the infection, thus risking financial loss and infertility in sexually active age patients. This literature review will discuss solithromycin, the first fluoroketolide in phase III clinical trial, and show its potential as a new antibiotic against infection with resistant Neisseria gonorrhoeae. Literatures are searched using Pubmed and Google Scholar search engines with keywords: antibiotics, CEM-101, clinical trial, Neisseria gonorrhoeae, new treatment, pharmacology, pharmacokinetics, resistance, safety, and solithromycin. This semisynthetic antibiotic is supported by a different chemical structure from previous macrolides; improving solithromycin becomes more stable and able to bind easier with bacterial ribosomes. Pharmacologically, solithromycin provides an advantage in its high bioavailability, easy oral administration route, wide distribution, metabolism mainly in the liver, but not required dosage adjustments due to hepatic impairment, and a single dosage preparation that can increase patient compliance in healing gonorrhea infections. Also, its lower MIC50 than previous antibiotics makes it well-tolerated, therefore making this antibiotic as a potential recommendation for the management of multi-drug resistant gonorrhea in the future. Solithromycin is not inferior to the standard therapy (ceftriaxone and azithromycin), with 80% vs. 84% gonorrhea eradication rates. Per the anatomic site, the eradication rate is 92% in genital, 94% in the pharynx, and 83% in the rectum. However, special attention needs to be paid to the side effects of the gastrointestinal tract of solithromycin, as observed in phase III clinical trials at a dose of 1000 mg in the form of diarrhea (24%) and nausea (21%).

scholarly journals COVID-19 Vaccine Race: An Overview and Update

2021 ◽  
Vol 11 (2) ◽  
pp. 171-177
Author(s):  
Md. Rayhan Chowdhury ◽  
Shirmin Islam ◽  
Mohammad Nurul Matin
Keyword(s):  
Clinical Trial ◽  
Vaccine Development ◽  
Vaccine Candidate ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Phase Iii ◽  
Health Crisis ◽  
Phase Iii Clinical Trials ◽  
Successful Vaccine ◽  
The World

A sudden health crisis has shut down the entire world for almost a year due to a new virus called Covid-19 and thus the WHO has declared the COVID-19 as a pandemic disease. As vaccines stimulate the immune system to fight against future infections, thereby conferring immunity, so far, vaccine development in a race throughout the world. Therefore, disseminating the overview of the vaccine development at present with their critical situation for COVID-19 is the aim of this review. The world is looking eagerly for a potential vaccine candidate that can save every life. Here, we reported the overview of the possible types of vaccines against Covid-19 as well as a glimpse of vaccine race with different phases of clinical trial data, comparison of the rate of success of phase-III clinical trials and their safety, and drawbacks with the present status. We have studied literature from clinical trial data of respective vaccine candidates published in the journals and collected data from databases dedicated to corona vaccine and the vaccine company's website to enrich our review and aiming to focus on clinical trial data stages, how consequences it faces, and how to position it belongs towards a successful vaccine candidate. Keywords: COVID-19, SARS-CoV-2, COVID-19 vaccine, Clinical trial.

Tildrakizumab: A Review of Phase II and III Clinical Trials

2018 ◽  
Vol 53 (4) ◽  
pp. 413-418 ◽  
Author(s):  
Sree S. Kolli ◽  
Sarah D. Gabros ◽  
Adrian Pona ◽  
Abigail Cline ◽  
Steven R. Feldman
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Biological Therapy ◽  
Common Adverse Effect ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Severe Psoriasis ◽  
Phase Iii ◽  
Physician Global Assessment ◽  
Phase Ii And Iii

Objective: Tildrakizumab, an inhibitor of the p19 subunit of interleukin (IL)-23, was recently Food and Drug Administration (FDA) approved for patients with moderate to severe psoriasis. This article will review the phase II and III clinical trial data of tildrakizumab. Data Sources: A PubMed search from January 2000 to September 2018 was done with the search terms tildrakizumab, guselkumab, risankizumab, p19, interleukin-23, and psoriasis. Study Selection and Data Extraction: Articles discussing phase II and III clinical trial data for tildrakizumab were selected. Data Synthesis: In phase II and phase III trials, tildrakizumab was safe and efficacious compared with placebo and etanercept. More patients achieved Psoriasis Area and Severity Index 75 receiving tildrakizumab (200 mg, 62%-74%; 100 mg, 61%-66%; 25 mg, 64%; 5 mg, 33%) compared with placebo (4%-6%, P < 0.0001) and etanercept (48%, P = 0.01). More patients achieved Physician Global Assessment (PGA) response of “clear” or “minimal” receiving tildrakizumab (200 mg, 59%; 100 mg, 55%-58%) than the placebo group (4%-7%, P < 0.0001). 59% of patients who received tildrakizumab 200 mg achieved a PGA response of “clear” or “minimal” compared with etanercept (48%, P = 0.0031). The most common adverse effect was infection. Relevance to Patient Care and Clinical Practice: Tildrakizumab is a new, FDA-approved, physician-administered biological therapy for patients with moderate to severe psoriasis. It appears to be efficacious and safe so far. Conclusion: Tildrakizumab is efficacious and safe for the treatment of patients with moderate to severe psoriasis. IL-23/p19 inhibitors are a promising class of biological therapy.

scholarly journals The case for introducing pre-registered confirmatory pharmacological pre-clinical studies

2018 ◽  
Vol 38 (5) ◽  
pp. 749-754 ◽  
Author(s):  
Olivia Kiwanuka ◽  
Bo-Michael Bellander ◽  
Anders Hånell
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Clinical Trials ◽  
Brain Injury ◽  
Network Analysis ◽  
Clinical Studies ◽  
Phase Iii ◽  
Phase Iii Clinical Trial ◽  
Phase Iii Clinical Trials ◽  
Experimental Drugs

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

scholarly journals A Review of Phase III Clinical Trials of Prostate Cancer Chemoprevention

2007 ◽  
Vol 89 (3) ◽  
pp. 207-211 ◽  
Author(s):  
JF Thorpe ◽  
S Jain ◽  
TH Marczylo ◽  
AJ Gescher ◽  
WP Steward ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Cancer Prevention ◽  
Age Of Onset ◽  
Cancer Chemoprevention ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Prostate Cancer Prevention ◽  
Phase Iii Trials

INTRODUCTION Prostate cancer is an excellent target for chemoprevention strategies; given its late age of onset, any delay in carcinogenesis would lead to a reduction in its incidence. This article reviews all the completed and on-going phase III trials in prostate cancer chemoprevention. PATIENTS AND METHODS All phase III trials of prostate cancer chemoprevention were identified within a Medline search using the keywords ‘clinical trial, prostate cancer, chemoprevention’. RESULTS In 2003, the Prostate Cancer Prevention Trial (PCPT) became the first phase III clinical trial of prostate cancer prevention. This landmark study was terminated early due to the 24.8% reduction of prostate cancer prevalence over a 7-year period in those men taking the 5α-reductase inhibitor, finasteride. This article reviews the PCPT and the interpretation of the excess high-grade prostate cancer (HGPC) cases in the finasteride group. The lack of relationship between cumulative dose and the HGPC cases, and the possible sampling error of biopsies due to gland volume reduction in the finasteride group refutes the suggestion that this is a genuine increase in HGPC cases. The other on-going phase III clinical trials of prostate cancer chemoprevention – the REDUCE study using dutasteride, and the SELECT study using vitamin E and selenium – are also reviewed. CONCLUSIONS At present, finasteride remains the only intervention shown in long-term prospective phase III clinical trials to reduce the incidence of prostate cancer. Until we have the results of trials using alternative agents including the on-going REDUCE and SELECT trials, the advice given to men interested in prostate cancer prevention must include discussion of the results of the PCPT. The increased rate of HGPC in the finasteride group continues to generate debate; however, finasteride may still be suitable for prostate cancer prevention, particularly in men with lower urinary tract symptoms.

Paucity of economic analyses of phase III clinical trials conducted by the cooperative oncology groups: A review of the evidence

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 17052-17052
Author(s):  
K. Fitzner ◽  
J. McKoy ◽  
C. L. Bennett
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Cost Effectiveness ◽  
Cancer Care ◽  
Phase Iii ◽  
Economic Data ◽  
Direct Medical Costs ◽  
Phase Iii Clinical Trials ◽  
Need To Evaluate ◽  
Economic Analyses

17052 Background: Cancer care is expensive, accounting for $72 billion in direct medical costs. New oncology drugs are frequently costly, and can be > $100,000 per patient. Hence, assessments of the costs and cost-effectiveness of cancer pharmaceuticals alongside phase III clinical trials conducted by the NCI-sponsored cooperative oncology groups represents an important opportunity to generate relevant economic data. Methods: Review of published cost and cost-effectiveness analyses for cancer drugs conducted alongside phase III clinical trials conducted by the NCI-sponsored cooperative clinical trial groups. Results: See Table . Conclusions: Despite increasing concerns over the high costs of cancer pharmaceuticals and the need to evaluate the costs and cost-effectiveness of these agents, NCI sponsored phase III clinical trials rarely include economic assessments. Future phase III clinical trials with expensive new cancer agents conducted by cooperative clinical trials groups should include prospective economic assessments. [Table: see text] No significant financial relationships to disclose.

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