Charles C. Wykoff

2 months ago | ajmc.com | Rose McNulty |Charles C. Wykoff

With the recent FDA approval of revakinagene taroretcel-lwey (Encelto; Neurotech Pharmaceuticals), patients with macular telangiectasia type 2 (MacTel) now have an approved treatment option for the progressive retinal condition characterized by irreversible vision loss. In an interview with The American Journal of Managed Care®, clinical investigator Charles C.

2 months ago | ajmc.com | Rose McNulty |Charles C. Wykoff

Revakinagene taroretcel-lwey (Encelto; Neurotech Pharmaceuticals) recently became the first and only FDA-approved treatment for macular telangiectasia type 2 (MacTel), a progressive retinal condition that can cause irreversible vision loss. The newly approved therapy fills a significant unmet need for patients with MacTel and employs a novel method of administration with potential in a broader range of retinal conditions, clinical investigator Charles C.

2 months ago | ajmc.com | Rose McNulty |Charles C. Wykoff

Following its recent FDA approval, revakinagene taroretcel-lwey (Encelto; Neurotech Pharmaceuticals) is the first and only therapy indicated for the treatment of macular telangiectasia type 2 (MacTel), a neurodegenerative disease of the retina that causes progressive, irreversible vision loss.1 The allogeneic encapsulated cell-based gene therapy employs a novel strategy for administration that facilitates continual benefits for a patient population that previously had no options.

Aug 31, 2024 | nature.com | Charles C. Wykoff

Retinal neovascular diseases, such as neovascular age-related macular degeneration (nAMD), diabetic retinopathy (DR), diabetic macular oedema (DMO), and retinal vein occlusion (RVO), are major causes of visual impairment worldwide [1,2,3]. Vascular endothelial growth factor (VEGF) is considered critical in the pathophysiology of these conditions and randomized trials have established the efficacy and safety of agents with an anti-VEGF mechanism of action [4].

Jul 20, 2024 | nature.com | Keean Nanji |Amin Hatamnejad |Mark Phillips |Dena Zeraatkar |Tien Yin Wong |Robyn Guymer | +8 more

The fragility index (FI) of a meta-analysis evaluates the extent that the statistical significance can be changed by modifying the event status of individuals from included trials. Understanding the FI improves the interpretation of the results of meta-analyses and can help to inform changes to clinical practice. This review determined the fragility of ophthalmology-related meta-analyses. Meta-analyses of randomized controlled trials with binary outcomes published in a journal classified as ‘Ophthalmology’ according to the Journal Citation Report or an Ophthalmology-related Cochrane Review were included. An iterative process determined the FI of each meta-analysis. Multivariable linear regression modeling evaluated the relationship between the FI and potential predictive factors in statistically significant and non-significant meta-analyses. 175 meta-analyses were included. The median FI was 6 (Q1–Q3: 3–12). This meant that moving 6 outcomes from one group to another would reverse the study’s findings. The FI was 1 for 18 (10.2%) of the included meta-analyses and was ≤5 for 75 (42.4%) of the included meta-analyses. The number of events (p < 0.001) and the p-value (p < 0.001) were the best predictors of the FI in both significant and non-significant meta-analyses. The statistical significance of meta-analyses in ophthalmology often hinges on the outcome of a few patients. The number of events and the p-value are the most important factors in determining the fragility of the evidence. The FI is an easily interpretable measure that can supplement the reader’s understanding of the strength of the evidence being presented. CRD42022377589