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Procedure

Photobiomodulation for Age-Related Macular Degeneration

Phase 2 & 3

Waitlist Available

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

No Placebo-Only Group

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.

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.

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

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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:

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

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I have an eye condition that blocks my pupil partially or fully.

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I do not have eye conditions other than dry AMD that could cause similar symptoms.

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I have vision problems without clear physical eye damage.

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I haven't used any photosensitizing agents in the last 30 days or have consulted my doctor if I did.

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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.

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I have open sores or skin redness around my eyes that worsen with light exposure.

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My vision isn't blocked by cataracts or similar issues in the study eye.

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I have a serious eye condition that is not dry AMD.

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I have not had cancer, except for certain skin or cervical cancers, in the last 5 years.

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I cannot walk by myself.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Contrast Seensitivity

Geographic Atrophy (GA)

Low Luminance BCVA

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met