← Back to Search

Procedure

Photobiomodulation 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
Must not have
Current or history of neovascular maculopathy
Ocular disorder or disease that partially or completely obstructs the pupil
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have or had a type of eye disease affecting my vision.
Select...
I have an eye condition that blocks my pupil partially or fully.
Select...
I do not have eye conditions other than dry AMD that could cause similar symptoms.
Select...
I have vision problems without clear physical eye damage.
Select...
I haven't used any photosensitizing agents in the last 30 days or have consulted my doctor if I did.
Select...
I am not currently in a clinical study and haven't been in one or received experimental treatments or devices in the last 3 months.
Select...
I have open sores or skin redness around my eyes that worsen with light exposure.
Select...
My vision isn't blocked by cataracts or similar issues in the study eye.
Select...
I have a serious eye condition that is not dry AMD.
Select...
I have not had cancer, except for certain skin or cervical cancers, in the last 5 years.
Select...
I cannot walk by myself.

Timeline

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.

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
548 Previous Clinical Trials
1,401,800 Total Patients Enrolled
~37 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top