Photobiomodulation for Age-Related Macular Degeneration

Not currently recruiting at 8 trial locations

Overseen By Richard Rosen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: LumiThera, Inc.

Must not be taking: Photosensitizing agents

Disqualifiers: Neovascular maculopathy, Cataracts, Glaucoma, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 36

Duration: 3-5 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to study the continued use of a light therapy treatment called the Valeda Light Delivery System for individuals with dry age-related macular degeneration (AMD), a condition that can lead to vision loss. The treatment uses specific light wavelengths to potentially improve eye health. Individuals who completed the previous LIGHTSITE III study or have dry AMD with specific eye characteristics, such as certain types of eye spots or damage, are suitable candidates. As a Phase 2, Phase 3 trial, this research evaluates the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to advancing AMD treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using any photosensitizing agents (medications that make your skin sensitive to light), you should consult your doctor before starting the treatment. Also, if you are taking anti-oxidant or vitamin supplements for dry AMD, you need to have been stable on them for at least one month before starting the trial.

What prior data suggests that the Valeda Light Delivery System is safe for treating age-related macular degeneration?

Research has shown that the Valeda Light Delivery System, a type of light therapy, has undergone safety testing for treating dry age-related macular degeneration (AMD). One study demonstrated its benefits for patients with intermediate dry AMD, indicating it is generally well-tolerated.

The FDA has now approved the treatment for early stages of this condition, confirming it has passed safety checks for this use. The FDA reviewed data from studies involving about 100 participants. While all treatments carry risks, this approval suggests those risks are manageable when used correctly.

In summary, current evidence indicates that the Valeda Light Delivery System is safe for people, but discussing any concerns with a doctor is always important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for AMD?

Researchers are excited about the Valeda Light Delivery System for age-related macular degeneration (AMD) because it offers a unique, non-invasive approach through photobiomodulation. Unlike traditional treatments like anti-VEGF injections, which target blood vessel growth, Valeda uses specific light wavelengths to stimulate cellular repair and reduce inflammation in the retina. This innovative mechanism could potentially improve vision without the need for frequent injections, making it a promising alternative for those seeking less invasive options.

What evidence suggests that the Valeda Light Delivery System is effective for age-related macular degeneration?

Research has shown that the Valeda Light Delivery System, a type of light therapy, may help treat dry age-related macular degeneration (AMD). In a previous study, participants who received this light therapy experienced noticeable improvements in vision over 13 months. The therapy uses specific light wavelengths to enhance visual clarity. Some studies have also found temporary improvements in vision and a decrease in drusen, the tiny yellow deposits in the eye. The FDA approved this therapy based on positive results, suggesting it could be a helpful option for those with dry AMD. Participants in this trial will receive the Valeda Light Delivery System as part of the Photobiomodulation (PBM) treatment arm. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who completed the CSP005 study, have dry age-related macular degeneration (AMD) with certain vision scores, and can follow the study requirements. They must not have other eye diseases that affect vision or a history of light sensitivity, recent invasive eye surgery, serious illnesses, cancer in the past 5 years (with exceptions), or substance abuse.

Inclusion Criteria

ETDRS BCVA letter score of between 50 and 75 (Snellen equivalent of 20/100 to 20/32) at Baseline

Participation in and completion of CSP005 study

Able to communicate well with the Investigator and able to understand and comply with the requirements of the study

Exclusion Criteria

Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation

In the opinion of the Investigator, is unlikely to comply with the study protocol

I have or had a type of eye disease affecting my vision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive photobiomodulation (PBM) treatment using the Valeda Light Delivery System for 9 treatments over a three to five-week period

3-5 weeks

9 visits (in-person)

Re-treatment

Participants undergo re-treatment with PBM at 4, 8, and 12 months, each consisting of 9 additional treatment visits

12 months

27 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Valeda Light Delivery System

Trial Overview The LIGHTSITEIIIB trial tests ongoing use of photobiomodulation (PBM) using the Valeda Light Delivery System on people with dry AMD who participated in a previous related study. It's an open-label extension meaning participants and researchers know what treatment is being used.

How Is the Trial Designed?

Group I: Photobiomodulation (PBM) Experimental Treatment 1 Intervention

The Valeda Light Delivery System will deliver two alternating and sequential treatments of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds; and 660 nm for 90 seconds, or a total of 180 seconds.

Who Is Running the Clinical Trial?

LumiThera, Inc.

Lead Sponsor

Trials

6

Recruited

760+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Published Research Related to This Trial

The IRay low voltage treatment system demonstrated an average targeting accuracy of 0.6 mm from the fovea in human cadaver eyes, indicating precise delivery of treatment for age-related macular degeneration (AMD).

The system was able to safely avoid the optic nerve during treatment, with the dose delivered to the fovea matching the prescribed levels, suggesting both safety and efficacy in targeting AMD lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic targeting and dose verification for age-related macular degeneration. Gertner, M., Chell, E., Pan, KH., et al.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37972955/

LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of ... LIGHTSITE III provides a prospective, randomized, controlled trial showing improved clinical and anatomical outcomes in intermediate dry AMD following PBM ...

2. macularsociety.org macularsociety.org/about/media/news/2024/march/encouraging-results-from-light-therapy-study-for-dry-amd/

Encouraging results from light therapy study for dry AMD After 13 months of treatment, eyes treated with photobiomodulation using the Valeda system showed significant improvement in vision compared to ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/reviews/DEN230083.pdf

DEN230083, Valeda Light Delivery System, LumiThera, Inc. The device treats or improves visual acuity in patients with dry age-related macular degeneration. NEW REGULATION NUMBER: 21 CFR 886.5520. CLASSIFICATION: II.

4. aao.org aao.org/eye-health/news/light-therapy-photobiomodulation-dry-amd-ga

FDA Authorizes Light Therapy for Dry AMD The FDA authorized light therapy for dry AMD based on results from a small study of 100 people in the early stages of the disease, treating some ...

5. nature.com nature.com/articles/s41433-024-03326-4

Short-term efficacy of photobiomodulation in early and ... PBM resulted in temporary improvements in visual function and a reduction in drusen volume, but these effects were not sustained at six months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12271020/

Multiwavelength Photobiomodulation Improves Multiple ... Multiwavelength photobiomodulation (PBM) treatment with the Valeda® Light Delivery System is a recently FDA-authorized treatment for earlier ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03878420

NCT03878420 | Study of Photobiomodulation to Treat Dry ... The Valeda Light Delivery System will treat through the open eyelid with the 590 nm and 850 nm wavelengths together. The 660 nm wavelength will be treated ...