Photobiomodulation for Age-Related Macular Degeneration

Recruiting at 8 trial locations

Overseen By Diana Do, 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

75 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is an open-label, prospective, multi-center extension study on the continued use of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) that participated in the CSP005 LIGHTSITE III study.

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 data supports the effectiveness of the treatment Valeda Light Delivery System for age-related macular degeneration?

Research suggests that photobiomodulation, which is the use of light therapy, can reduce drusen (yellow deposits under the retina) and improve vision in patients with dry age-related macular degeneration. Additionally, studies have shown that using 670 nm light can increase phagocytosis (the process by which cells remove waste) in retinal cells, which may help counteract damage caused by oxidative stress in AMD. ^{1 2 3 4 5}

Is photobiomodulation therapy safe for humans?

Photobiomodulation therapy, including the use of the Valeda Light Delivery System, has been evaluated for safety in treating age-related macular degeneration. Studies have shown it is generally safe for humans, with approval from the Food and Drug Administration and the European Medicines Agency for treating intermediate AMD. ^{6 7 8 9 10}

How does the Valeda Light Delivery System treatment differ from other treatments for age-related macular degeneration?

The Valeda Light Delivery System uses photobiomodulation, a treatment with light in the far-red to near-infrared spectrum, which is unique because it can reduce drusen volume and improve visual acuity and contrast sensitivity in dry age-related macular degeneration, unlike traditional treatments that mainly focus on symptom relief. ^{1 2 4 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Emerging biological therapies for age-related macula degeneration. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Photobiomodulation reduces drusen volume and improves visual acuity and contrast sensitivity in dry age-related macular degeneration. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Pilot Study Evaluating the Effects of 670 nm Photobiomodulation in Healthy Ageing and Age-Related Macular Degeneration. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation with 670 nm light increased phagocytosis in human retinal pigment epithelial cells. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

PROGRESSION OF MACULAR ATROPHY IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION UNDERGOING ANTIVASCULAR ENDOTHELIAL GROWTH FACTOR THERAPY. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

LIGHTSITE III: 13-Month Efficacy and Safety Evaluation of Multiwavelength Photobiomodulation in Nonexudative (Dry) Age-Related Macular Degeneration Using the LumiThera Valeda Light Delivery System. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Shedding Light on Photobiomodulation Therapy for Age-Related Macular Degeneration: A Narrative Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Safety of recent ophthalmic drugs and devices for wet macular degeneration. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A DOUBLE-MASKED, RANDOMIZED, SHAM-CONTROLLED, SINGLE-CENTER STUDY WITH PHOTOBIOMODULATION FOR THE TREATMENT OF DRY AGE-RELATED MACULAR DEGENERATION. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Stereotactic targeting and dose verification for age-related macular degeneration. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Biotechnology and Biomaterial-Based Therapeutic Strategies for Age-Related Macular Degeneration. Part I: Biomaterials-Based Drug Delivery Devices. [2020]