Final patient visit done in trial testing Celeste light therapy for Parkinson’s
Top-line results from large, pivotal study to be shared at May 26 conference
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- A large pivotal trial testing Celeste light therapy as an added Parkinson's treatment is now complete.
- The device aims to ease motor and nonmotor symptoms by regulating the body's circadian rhythms.
- Top-line results will be presented at a conference on May 26; a regulatory submission may follow.
A pivotal clinical trial testing the light therapy device Celeste for Parkinson’s disease has wrapped up, with the last enrolled participant completing the study’s final visit.
That’s according to a company press release from device developer Photopharmics, which called the completion of the large study a “key milestone.” Led by researchers at the University of Rochester in New York, the trial evaluated whether Celeste, a noninvasive, at-home photo-neuromodulation device, could ease symptoms of Parkinson’s — both motor and nonmotor — when used alongside standard treatments.
The Phase 3 trial, called LIGHT for PD (NCT04453033), had enrolled 351 adults with Parkinson’s across the U.S. Eligible participants, ages 45 and older, were required to have “relatively good eyesight” to use the therapy.
“With completion of the trial, we now have a comprehensive dataset to further evaluate photo-neuromodulation as a novel, non-invasive approach under investigation in Parkinson’s,” said Dan Adams, chief science officer and cofounder of Photopharmics.
Top-line results will be presented on May 26 at the upcoming World Parkinson Congress in Phoenix, according to the company.
Kent Savage, Photopharmics’ CEO and cofounder, said the company is “grateful to the care partners, investigators, and coordinators who made this program possible and look forward to sharing the trial findings with the clinical community.”
“This milestone belongs first to the patients — people living with Parkinson’s disease who contributed their time to a trial aimed at advancing new approaches to care,” Savage said.
Developer intends to pursue regulatory approval if results are positive
Celeste was granted breakthrough device designation by the U.S. Food and Drug Administration (FDA), a status intended to speed development and review of promising medical devices for serious conditions.
Following the release of the trial’s results, Photopharmics said it plans to pursue regulatory steps toward potential approval of the Celeste device for use alongside standard Parkinson’s treatments.
The progressive disease is marked by the loss of nerve cells that produce dopamine, a signaling molecule essential for controlling movement. While motor symptoms are a hallmark of Parkinson’s, many people also experience nonmotor symptoms, including sleep problems and fatigue. Mood changes and cognitive difficulties can also occur.
Growing evidence suggests that disruptions in the body’s circadian rhythm, the internal biological clock that regulates essential functions such as sleep and metabolism, may contribute to the development of both motor and nonmotor Parkinson’s symptoms and reduced quality of life.
Celeste is a compact, tablet-sized device that emits specific wavelengths of light to stimulate photoreceptors — light-sensitive cells in the back of the eye that help regulate circadian rhythms. The light emitted by the device is based on Photopharmics’ Spectramax technology.
Designed for one hour of at-home use each evening, Celeste can be placed on a table or desk and positioned toward the user’s face. This enables patients to receive light therapy passively while carrying out everyday activities, such as watching television, eating dinner, or reading.
Participants used Celeste light therapy device at home for 6 months
The device was previously tested in an earlier clinical trial (NCT02175472) involving 92 people with Parkinson’s who were receiving stable dopamine replacement therapy. After six months, Celeste reduced disease severity, eased nonmotor symptoms, and improved quality of life compared with a similar device emitting light not expected to provide therapeutic benefits.
“The Light for PD trial was designed to rigorously evaluate a hypothesis that has been building in the scientific literature for years — that circadian biology and Parkinson’s disease are meaningfully connected, and that a precisely controlled light intervention could have an impact across both motor and non-motor domains,” said Ray Dorsey, MD, professor of neurology at the University of Rochester Medicine and trial’s lead investigator.
The conclusion of participant follow-up represents the culmination of years of scientific work and a major step to completion. … We built this trial to be rigorous. … We now have the opportunity to analyze a dataset that this trial was designed to generate.
Participants in Light for PD were randomly assigned to use either the Celeste device or a sham device emitting a different range of light wavelengths not expected to have therapeutic effects. The study period spanned about six months.
The trial used a fully remote, home-based design, with assessments conducted via virtual visits at the start of the study and again at three and six months to evaluate changes in quality of life and motor and nonmotor symptoms.
Initial findings highlighted some challenges with remote consent and software navigation, but ultimately showed that all participants were able to successfully set up and use the device at home.
“The conclusion of participant follow-up represents the culmination of years of scientific work and a major step to completion of an innovative and patient-oriented trial design,” said Karl Kieburtz, MD, chief medical officer of Photopharmics. “We built this trial to be rigorous — remote assessments, double-blinded, and designed to evaluate outcomes across both motor and non-motor measures. We now have the opportunity to analyze a dataset that this trial was designed to generate.”
Chris Collier
I would like to volunteer for future trials.
Judy Clobridge
Are there any test subject concerns that have had cataracts removed or any concerns with the Celeste trials causing any potential issues with the eyes or lenses?