PhotoPharmics, in partnership with the Center for Health + Technology (CHeT) at the University of Rochester Medical Center (URMC), has initiated a groundbreaking pivotal trial named the “Celeste Light for PD Trial.” This significant research effort aims to evaluate the efficacy of the Celeste® phototherapy device in improving both non-motor and motor functions and the quality of life in patients with Parkinson’s Disease (PD). Leveraging the company’s innovative Spectramax™ technology, the Celeste device offers a passive and non-invasive treatment option that has previously shown promising results in enhancing the lives of PD patients.
The trial, marked by the FDA’s Breakthrough Device Designation for Celeste® received in April 2020, underscores its potential as a transformative treatment modality for PD. Following challenges such as funding issues and delays attributable to the global pandemic, the launch of this 300-patient phototherapy trial, the largest of its kind to explore such technology, has been met with enthusiasm. PhotoPharmics CEO Kent Savage and Chief Science Officer Dan Adams highlighted the device’s remarkable impacts observed in earlier trials on improving patients’ quality of life and addressing non-motor symptoms, paving a new path in PD care.
Celeste® aims to mitigate PD symptoms by targeting photoreceptors in the eye connected to circadian signaling, affecting various aspects from tremors and sleep to cognition and depression. This novel approach underlines the device’s uniqueness in the current treatment landscape for PD.
The trial will be conducted remotely over six months, allowing participants to use the Celeste device daily from the comfort of their homes during their evening routines without altering their existing medical treatments. This telemedicine-based format, led by Dr. Ray Dorsey, Professor of Neurology at URMC and the trial’s lead investigator, ensures greater accessibility and participation across diverse demographics, including remote areas.
Notably, the trial will also focus on addressing severe PD symptoms like sleep disturbances, fatigue, depression, anxiety, and cognitive issues—areas currently lacking FDA-approved treatments. These symptoms often profoundly impact patients’ lives, making the Celeste trial all the more critical in exploring effective interventions for improving the overall quality of life for individuals living with PD.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.