A potential primary endpoint for clinical trials in glaucoma ...

A potential primary endpoint for clinical trials in glaucoma ... - Nature

In this retrospective, longitudinal study assessing real-world data of glaucomatous patients, we found that eyes experiencing rapid 24-2 visual ...

A potential primary endpoint for clinical trials in glaucoma ... - PubMed

0.36 (0.00 to 1.00) dB/year and -1.16 (-1.98 to -0.40) vs. 0.41 (0.02 to 1.03) dB/year, respectively (P < 0.001). It was found that eyes ...

Endpoints for clinical trials in ophthalmology - ScienceDirect.com

Intraocular pressure (IOP) is historically used as a surrogate endpoint for glaucoma. This endpoint is used for decades in drug approval and the challenges of ...

Validating Trend-Based End Points for Neuroprotection Trials in ...

When managing glaucoma, visual field (VF) damage is quantified and monitored with Standard Automated Perimetry (SAP). Moreover, SAP is a key ...

(PDF) A potential primary endpoint for clinical trials in glaucoma ...

Conclusion: Given the importance of not missing conversion to glaucoma, the frequency of testing employed in OHTS (6 mo) was optimal for detection of ...

Visual Field Mean Deviation Slopes: A Potential Primary Endpoint ...

Most clinical studies to date assessing glaucoma progression endpoints have included large populations followed for 4 or more years;1–5 the cost ...

(PDF) Visual Field Mean Deviation Slopes: A Potential Primary ...

If this correlation is strong and highly predictive, clinical trials employing MD slopes as primary endpoints could be employed in neuroprotection clinical ...

A potential primary endpoint for clinical trials in glaucoma ...

A potential primary endpoint for clinical trials in glaucoma neuroprotection ; Scientific reports 2023-05, Vol.13 (1), p.7098-7098, Article 7098 · De Moraes, ...

Sample Size Requirements of Glaucoma Clinical Trials When Using ...

Glaucoma clinical trials using visual field (VF) endpoints currently require large sample sizes because of the slowly-progressive nature of ...

Clinical Trials in Glaucoma - EyeWiki

A succint review of landmark clinical trials in the treatment of glaucoma and ocular hypertension.

A potential primary endpoint for clinical trials in glaucoma ...

Visual field tests of patients with or suspected glaucoma were selected from an academic institution and evaluated based on two functional progression endpoints ...

A Report from the NEI/FDA CDER Glaucoma Clinical Trial Design ...

Currently, clinical drug trials are focused on intraocular pressure (IOP) measurements and/or visual field tests (a functional outcome measure) for the ...

Glaucoma Clinical Trials - Mayo Clinic Research

Its primary objective is to conduct a prospective observational study on the efficacy of using MP-TSCPC to treat glaucoma patients. A Study to Evaluate ...

Glaucoma Clinical Research: Trends in Treatment Strategies and ...

Most studies evaluated the IOP-lowering effect as primary efficacy outcome (Table 2). Overall, 92% of the trials registered in the two databases evaluated IOP, ...

NEI/FDA Glaucoma Clinical Trial Design and Endpoints Symposium ...

Chambers agrees that structural measurements could replace visual function, although no structural endpoints are currently used for glaucoma. Structural ...

Assessment of the Impact of an Endpoint Committee in the Ocular ...

To assess the impact of a masked Endpoint Committee on estimates of the incidence of primary open-angle glaucoma (POAG) treatment efficacy and statistical ...

Evaluating Primary Treatment for People with Advanced Glaucoma

Participants were randomized on a 1:1 basis to have either mitomycin C-augmented trabeculectomy or escalating medical management with intraocular pressure (IOP)- ...

Designing a Clinical Trial for Glaucoma Treatments

Currently, the FDA generally accepts IOP and visual field (VF) endpoints for evaluating new treatments for glaucoma. STRUCTURAL AND FUNCTIONAL ENDPOINTS.

Nicotinamide and Pyruvate for Neuroenhancement in Open-Angle ...

This phase 2 randomized clinical trial tests the hypothesis that a combination of nicotinamide and pyruvate can improve retinal ganglion ...

Landmark Glaucoma Studies: Key Findings and Treatment Lessons

Although visual fields were the primary outcome measure, the CIGTS was the first clinical glaucoma trial to include quality of life as an ...