Endpoints for clinical trials in ophthalmology

Endpoints for clinical trials in ophthalmology - PubMed

With the identification of novel targets, the number of interventional clinical trials in ophthalmology has increased. Visual acuity has for ...

Endpoints for clinical trials in ophthalmology - ScienceDirect.com

In this article we summarize candidates for clinical endpoints in ophthalmology with a focus on retinal disease and glaucoma.

White Paper Ophthalmic Study Endpoints | Cromsource

Ophthalmic studies rely on complex tests and assessments to meet clinical study endpoints. Each test may be time-consuming to administer, assess, ...

The Evolution of Clinical Trial Endpoints for Wet AMD

A critical feature of clinical trial design is selecting endpoints, which, if appropriate, render the trial valid, relevant, and therefore ...

The Evolution of Clinical Trial Endpoints for Diabetic Retinopathy

With the person scale shown in Table 2, at baseline and at the final outcome time point, the status of the worse eye is weighted to determine ...

(PDF) Endpoints for clinical trials in ophthalmology - ResearchGate

Visual acuity has for a long time been considered the gold standard endpoint for clinical trials, but in the recent years it became evident that ...

Visual Function Endpoints to Enable Dry AMD Clinical Trials - PMC

The standard endpoint used for ophthalmic clinical trials, best-corrected visual acuity, is insensitive to the early stages and slow progression of dry AMD.

Update on Clinical Trial Endpoints in Gene Therapy Trials for ... - MDPI

Best-corrected visual acuity, as well as static or kinetic perimetry, have been the “gold standards” for measuring efficacy in ophthalmology, and they have ...

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 ...

Informing Endpoints for Clinical Trials of Geographic Atrophy

... Eye Disease Study 2 report 32. . Ophthalmology 130:(5):488–500 ... The clinical relevance of visualising the peripheral retina. . Prog ...

Clinical Endpoints for Retinal Disorders - Retina Today

The key word here is validated: for the FDA, this means that a structural endpoint shows a strong correlation to current vision or future vision ...

Report from the NEI/FDA Ophthalmic Clinical Trial Design and ...

An anatomic endpoint is an anatomic feature that is measured at the end of a study to assess whether a given treatment works. As part of his introductory ...

Biomarkers and surrogate endpoints in glaucoma clinical trials

This article reviews the general requirements for validating surrogate endpoints and provides a critical assessment of the use of intraocular pressure (IOP), ...

Clinical Endpoints in the era of ophthalmic precision medicine

Drug molecules and biologics are necessary for a new drug, and clinical endpoints are the outcome measures for assessing safety and ...

GA: Alternative Endpoints - The Ophthalmologist

Current primary endpoints for GA clinical trials focus on the structural endpoint of GA lesion growth. ... Quantification of the GA Lesion Area: ...

Use of Composite End Points in Early and Intermediate Age-Related ...

The use of composite end points is also met with interest in other areas of ophthalmology. Due to the absence of a gold standard of determining ...

Biomarkers and Surrogate Endpoints in Ophthalmic Clinical ... - IOVS

This special issue collects original research, reviews, scientific, and regulatory perspectives focusing on biomarkers and surrogate endpoints in ophthalmic ...

Choosing endpoints in clinical studies and trials | Eye - Nature

Currently, it is challenging to select endpoints for measuring disease progression in glaucoma clinical trials. The endpoints that are used ...

VIDEO: Experts consider endpoints for clinical trials in geographic ...

CHICAGO — In this video, Joan W. Miller, MD, chair of ophthalmology at Mass Eye and Ear, discusses highlights from the AAO meeting.

Visual Function Endpoints The Regulatory Perspective

Confirmatory Clinical Trials planned with an adaptive design. ▫ CPMP/EWP/1776/99 Rev. 1 Guideline on missing data in confirmatory clinical ...