Friday, September 29, 2023

The rise of labyrinth assessments in clinical trials of inherited retinal diseases

The use of mobility tests, also known as mazes, is becoming increasingly common in clinical trials of inherited retinal diseases (ERH). The aim of these tests is to evaluate the functional effects of possible therapies. With the recent development of virtual reality (VR) headsets, there is potential for VR mobility assessments to become the standard for evaluating the effectiveness of these studies.

In physical mazes, patients navigate through a series of tasks, such as: B. by following arrows, avoiding obstacles and reaching a certain end point. Alternatively, in VR mazes, patients wear glasses, foot and hand trackers as they follow virtual arrows towards a virtual door. VR mazes offer the advantage of controlling conditions and testing different patterns, ensuring reliability, participant safety and repeatability.

Although mobility tests have been used to evaluate ERH, they have not been widely used in clinical trials. The recent FDA approval of pegcetacoplan based on a structural endpoint suggests the possibility of using structural endpoints such as photoreceptor loss on OCT in ERH studies. However, functional tests that can be translated to real-world activities have additional benefits, such as assessing the patient’s ability to navigate the road or drive a vehicle.

Researchers have conducted studies using physical and VR mazes to evaluate the effectiveness of treatments for ERH. These studies showed that treated patients performed better than controls, and the tests were able to differentiate between different disease groups. VR mazes have also demonstrated their ability to correspond with the real world. However, a comprehensive comparison of physical and VR mobility assessments is required to determine the validity of VR mazes in HRE assessments.

As industry adopts standardized mobility assessments in clinical trials, several milestones must be achieved. A comprehensive comparison between physical and VR mobility testing is essential. Additionally, ophthalmology may need to adopt a standardized test, and professional associations may need to revise their practice patterns to include ERHs and specify the use of mobility assessments.

Sources: Luxturna Clinical Trial, RUSH2A Trial, Russell et al., Chung et al., Roman et al., Kumaran et al., Aleman et al., Bennett et al., Chebat et al.

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