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Procedure

Photobiomodulation (PBM) for Age-Related Macular Degeneration

Phase 2 & 3

Recruiting

Research Sponsored by LumiThera, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of dry AMD as defined by the presence of intermediate size or larger drusen with at least a few regular drusen and/or geographic atrophy visible on color fundus images, OCT and/or FAF, with no presence of center involving GA within the central ETDRS 1 mm diameter

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is a continuation of a previous study on the use of photobiomodulation in people with dry age-related macular degeneration. It is open to participants from multiple centers.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort due to light exposure from PBM therapy. Participants should not have known light sensitivity or skin conditions exacerbated by light.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have dry AMD with specific eye changes but no central vision loss.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA)

Secondary outcome measures

Contrast Seensitivity

Geographic Atrophy (GA)

Low Luminance BCVA

Trial Design

1Treatment groups

Experimental Treatment

Group I: Photobiomodulation (PBM)Experimental Treatment1 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

LumiThera, Inc.Lead Sponsor

5 Previous Clinical Trials

685 Total Patients Enrolled

National Eye Institute (NEI)NIH

547 Previous Clinical Trials

1,402,082 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being enrolled in this clinical trial?

"To complete this clinical trial, a total of 75 eligible patients are required to participate. Patients from different regions, including Cherry Hill in New jersey (specifically at Mid Atlantic Retina) and Altamonte Springs in Florida (particularly at the Florida Eye Clinic), can take part in this study."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"Indeed, the information available on clinicaltrials.gov affirms that this trial is actively seeking individuals to participate. The study was initially posted on October 25th, 2023, and has been recently updated on January 19th, 2024. There are a total of nine locations where they aim to enroll 75 patients in this study."

Answered by AI

In how many different medical centers can patients access this clinical trial?

"Among the nine operational sites for this clinical trial, notable locations include Mid Atlantic Retina in Cherry Hill, Florida Eye Clinic in Altamonte Springs, and Retina Vitreous Associates Medical Group in Beverly Hills. Additionally, there are another six locations participating in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITEIIIB)

2023. "Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITEIIIB)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06229665.