Virtual Phase 3 Trial of At-home Light Therapy May Open in Summer
PhotoPharmics plans to open, possibly this summer, a pivotal Phase 3 clinical trial of its light-based and noninvasive Celeste device in treating Parkinson’s symptoms, for use by patients at home and with trial goals evaluated using telemedicine.
A particular company goal for this device, PhotoPharmics also announced, is reaching underserved patients in more remote areas of the U.S., in keeping with potential changes in Medicare coverage for medical devices.
The trial (NCT04453033) — called “Celeste Light for PD Trial” — aims to recruit 200 patients, ages 45 and older, to test the devise in addition to current therapy. Set as a collaboration between PhotoPharmics and the Center for Health + Technology (CHeT) at the University of Rochester Medical Center, enrollment is not yet open. Contact information for this study is available here.
During the trial, participants will be randomized to use the Celeste phototherapy device or a sham device (producing the same bandwidths of light, but at different intensities) for one hour each day for six months. The phototherapy device is described as being similar to a tablet, with a stand that allows it be angled to the face, and “fits into a person’s daily home routine,” the company stated on a webpage.
Patients will be “recruited electronically and enrolled via Zoom,” the company announced in its release. Celeste “will be drop-shipped to patients’ homes across the U.S. Then, medical staff will assure proper set up, use of the device, and symptom assessment via telehealth.”
This trial’s main goal is to assess the effects of the phototherapy device on patients’ motor and non-motor symptoms, assessed in Part 1 and Part 2 of the Movement Disorders Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), a four-part doctor and patient evaluation of the disease and how it affects daily life.
Additional goals include assessing patient-reported quality of life, measured with the Parkinson’s Disease Questionnaire-39 (PDQ-39), and changes in daytime sleepiness — assessed through the Epworth Sleepiness Scale (ESS). ESS is a self-administered questionnaire with scores ranging from zero to 24; scores greater than 10 indicate higher-than-normal levels of daytime sleepiness.
PhotoPharmic’s Celeste uses a combination of light intensities and bandwidths to help regulate the circadian rhythm, our body’s “natural clock” that works to regulate essential functions such as sleep and metabolism. Problems with the circadian rhythm in Parkinson’s patients are thought to contribute to both disease motor and non-motor symptoms.
Data from a Phase 2 clinical trial (NCT02175472), which took place in the U.S. and the Netherlands, showed that the light therapy eased disease severity as measured through the MDS-UPDRS, and significantly lessened non-motor symptoms.
In the trial, 92 Parkinson’s patients — ages 45 or older, and all taking dopaminergic therapy — received either phototherapy or a placebo light for one hour each evening for six months.
PhotoPharmic aims to make the Celeste device available for use in the home as soon as possible, and to patients in more remote locations with limited access to care, regardless of income level.
The medical device company is awaiting potential final approval in May of what is known as the Medicare Coverage of Innovative Technology (MCIT) rule. Proposed by the Centers for Medicare & Medicaid Services (CMS), this rule is designed to expedite Medicare coverage for new and innovative technologies, “providing early access to new treatments,” PhotoPharmics said in its release.
Medicare coverage, which can be granted on the same day as FDA approval, may continue for up to four years.
Specifically, the MCIT rule aims to grant immediate Medicare coverage to products designated as breakthrough medical devices by the U.S. Food and Drug Administration (FDA). The designation is given to devices with the potential to effectively treat life-threatening or debilitating diseases, such as Parkinson’s.
The Celeste phototherapy device was named a breakthrough device by the FDA in July 2020.
A vote to put the rule into effect was postponed in March, and is now expected on May 15.
“With approximately 90 percent of people with Parkinson’s already covered by Medicare, this coordination between FDA and CMS will remove approval and payment barriers and allow expedited access to those who suffer most — regardless of their income,” said Kent Savage, the CEO of PhotoPharmics.
“Some estimate that as high as 35 percent of those covered by Medicare live in remote locations and have far less access to quality care,” Savage said.
“Reaching and serving these patients in their home has always been our priority. Our therapeutic device will fit naturally into this rapidly expanding system of care — from remote physician prescriptions to drop-shipping methods that make reaching patients anywhere more possible than ever before,” he added.