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Active, not recruitingNCT06229665Updated Jul 3, 2024

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

A Phase 2/3 interventional study of Valeda Light Delivery System in Dry Age-related Macular Degeneration, sponsored by LumiThera, Inc.. Active, not recruiting at 7 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by LumiThera, Inc. · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2025, 1 year 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Phase 2/3
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This study is an open-label, prospective, multi-center study on the use of PBM as a treatment for visual impairment in subjects with dry AMD. Subjects diagnosed with dry AMD who meet all inclusion criteria and have none of the exclusion criteria will be eligible to participate in this clinical study. All subjects will be treated with the Valeda Light Delivery System and will receive PBM treatment for a total of 9 treatments over a three to five-week period (3 times per week for 3 weeks is preferable). There will be a re-treatment period starting at the 4-month time point to include 9 additional treatment visits, to be repeated again at 8 months and 12 months. LumiThera will use settings for the 3 wavelengths that were used in the CSP005 study. The subject population for this study will consist of all subjects that completed the CSP005 study, meet the inclusion/exclusion criteria for the CSP010 study, are interested in study participation and have signed the Informed Consent Form.

02

Conditions studied

  • Dry Age-related Macular Degeneration

Keywords

  • dry age-related macular degeneration
  • photobiomodulation
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's planned enrollment of 75 is above the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

LumiThera, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Entry Criteria: Inclusion Criteria (each eye qualifies for the study independently):

  1. Participation in and completion of LIGHTSITE III study.
  2. Eye was randomized in LIGTHTSITE III study or diagnosis of dry AMD as defined by the presence of the following: Drusen that are intermediate in size or larger (63 μm or larger in diameter) with at least a few (3) being regular drusen and not pseudodrusen and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or FAF. The reading center will confirm criteria for NEW EYES only (i.e., those not randomized in LIGHTSITE III) with one of the following: 1) LIGHTSITE IIIB Screening Visit images (Screening visit only performed if there are >90 days between LIGHTSITE III Mo 24 visit and the start of the LIGHTSITE IIIB study) or 2) LIGHTSITE III Mo 24 images (if \<90 days passes between LIGHTSITE III Mo 24 and the start of the LIGHTSITE IIIB study).
  3. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
  4. Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines

Exclusion Criteria (each eye qualifies for the study independently):

  1. Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center):

    1. Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
    2. Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE)
    3. Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)
    4. Subretinal and sub-RPE fibrovascular proliferation
    5. Disciform scar (subretinal fibrosis)
  2. Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 12 months.
  3. Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require surgery in the study eye in the next 12 months.
  4. Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three months prior to Baseline
  5. Ocular disorder or disease that partially or completely obstructs the pupil (e.g. posterior synechia in uveitis)
  6. Visually significant disease in any ocular structure apart from dry AMD (e.g. diabetic macular edema, glaucoma (using >2 eye drop medications, uncontrolled IOP and/or central/paracentral visual field loss), glaucoma surgery, active uveitis, active vitreous disease, intraocular tumor, retinal vascular diseases)
  7. Ocular disorder or disease other than dry AMD that could cause drusen (glomerulonephritis Type 2, Autosomal dominant drusen), GA (North Carolina dystrophy) or mitochondrial diseases (parafoveal petaloid GA, Stargardt disease)
  8. Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus)
  9. Serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study
  10. Presence of or history of malignancy within the past 3 years other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ
  11. Is non-ambulatory
  12. Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if they have a history of light activated CNS disorders (e.g. epilepsy, migraine)
  13. Use of any photosensitizing agent (e.g. topicals, injectables, oral) activated by the Valeda Light Delivery System wavelengths within 30 days of treatment without consulting subject's physician
  14. History of drug, alcohol or substance abuse within 3 months prior to Baseline
  15. Participation in any other clinical study at time of Baseline, or has received an investigational drug or treatment with an investigational device within 3 months prior to Baseline
  16. If on any anti-oxidant or vitamin Age-Related Eye Disease Study (AREDS) supplement for dry AMD, has not been stabilized for a minimum of 1 month prior to Baseline. Subjects are considered to be stable if they are taking the AREDS supplements consistently as prescribed by their treating doctor.
  17. Has received Low Vision Rehab/Therapy within 30 days prior to Baseline or intends to receive during the study
  18. Has an open sore(s) that may come in contact with the Valeda System, has periorbital skin erythema or is prone to such conditions with exposure to light.
  19. In the opinion of the Investigator, is unlikely to comply with the study protocol
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Photobiomodulation (PBM)

    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.

    Device: Valeda Light Delivery System

Interventions

  • DeviceValeda Light Delivery System

    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.

06

What researchers measure

Primary outcomes

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

    Mean change from baseline in BCVA.

    Time frame: 12 months

Secondary outcomes

  1. Low Luminance BCVA

    Mean change from baseline in the LLBVCA.

    Time frame: 12 months

  2. Contrast Seensitivity

    Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.

    Time frame: 12 months

  3. Geographic Atrophy (GA)

    Number of new onset GA

    Time frame: 12 months

07

Study locations

7 sites
  • Retina Vitreous Associates Medical Group
    Beverly Hills, California 90211, United States
  • Stanford University
    Palo Alto, California 94303, United States
  • Florida Eye Clinic
    Altamonte Springs, Florida 32701, United States
  • Cumberland Valley Retina Consultants
    Hagerstown, Maryland 21749, United States
  • New York Ear and Eye Infirmary
    New York, New York 10003-4284, United States
  • Gulf Coast Eye Institute
    McAllen, Texas 78503, United States
  • Retina Center Northwest
    Silverdale, Washington 98383, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06229665
Lead sponsor
LumiThera, Inc.
Collaborators
National Eye Institute (NEI)
Responsible party
Sponsor
First posted
Jan 29, 2024
Start date
Oct 25, 2023
Primary completion
May 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Jul 3, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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