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Active, not recruitingNCT04065490Updated Feb 5, 2021

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

An interventional study of Valeda PBM treatment and Valeda Sham treatment in Dry Age-related Macular Degeneration, sponsored by LumiThera, Inc.. Active, not recruiting at 11 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-02-05.

Sponsored by LumiThera, Inc. · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2022, 4 years 4 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.

Read the detailed description

This study is a double-masked, sham-controlled, parallel design prospective, multi-site study on the use of photobiomodulation (PBM) as a treatment for visual impairment in subjects with dry AMD. Subjects will receive repeated sham or PBM treatments at several time-points throughout the 2-year study.

02

Conditions studied

  • Dry Age-related Macular Degeneration

Keywords

  • Dry age-related macular degeneration
  • Photobiomodulation
  • Visual Acuity
  • Contrast Sensitivity
  • Drusen
  • Optical coherence tomography
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 96 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

Inclusion criteria

  1. Male or female at least 50 years of age at Screening visit
  2. ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32). *If the subject meets this criterion at the Screening Visit, but the Baseline BCVA letter score is between 48 and 77, the subject may be entered in the study.
  3. 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, to be confirmed by the reading center

  4. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
  5. Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines

Exclusion criteria

Exclusion Criteria:

  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. Presence of center involving GA within the central ETDRS 1 mm diameter at Screening, to be confirmed by the reading center
  3. 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 24 months.
  4. 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 24 months.
  5. Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
  6. Ocular disorder or disease that partially or completely obstructs the pupil (e.g. posterior synechia in uveitis)
  7. 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)
  8. 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)
  9. Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus)
  10. 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
  11. Presence of or history of malignancy within the past 5 years other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ
  12. Is non-ambulatory
  13. 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)
  14. Use of any photosensitizing agent (e.g. topicals, injectables, oral) within 30 days of treatment without consulting subject's physician
  15. History of drug, alcohol or substance abuse within 3 months prior to Screening
  16. Has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
  17. 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 Screening. Subjects are considered to be stable if they are taking the AREDS supplements consistently as prescribed by their treating doctor.
  18. Has received Low Vision Rehab/Therapy within 30 days prior to Screening or intends to receive during the study
  19. 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.
  20. In the opinion of the Investigator, is unlikely to comply with the study protocol
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    PBM Treatment

    The Valeda™ Light Delivery System

    Device: Valeda PBM treatment

  • Sham comparator
    Sham Treatment

    The Valeda™ Light Delivery System non-effective treatment

    Device: Valeda Sham treatment

Interventions

  • DeviceValeda PBM treatment

    The Valeda Light Delivery System

  • DeviceValeda Sham treatment

    The sham mode of the Valeda Light Delivery System.

06

What researchers measure

Primary outcomes

  1. Best Corrected Visual Acuity

    Mean change from baseline in BCVA.

    Time frame: 21 months

Secondary outcomes

  1. Contrast Sensitivity

    Mean change from baseline (pre-treatment) in contrast sensitivity at 40 cm.

    Time frame: 21 months

  2. Central Drusen Volume

    Mean change from baseline (pre-treatment) in central Drusen volume.

    Time frame: 21 Months

  3. Central Drusen Thickness

    Mean change from baseline (pre-treatment) in central Drusen thickness.

    Time frame: 21 Months

Other outcomes

  1. Contrast Sensitivity

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

    Time frame: 21 Months

  2. Visual Function Questionnaire

    Mean change from baseline (pre-treatment) in Visual Function Questionnaire (VFQ-25) composite score.

    Time frame: 21 Months

  3. Reading Speed

    Mean change from baseline (pre-treatment) to Month 21 in monocular reading speed assessed by the Radner Reading Chart.

    Time frame: 21 Months

  4. Geographic Atrophy

    Mean change from baseline in the GA lesion area of the PBM treatment group versus the sham treatment group, as measured by FAF.

    Time frame: 21 Months

  5. Low Luminance- Best Corrected Visual Acuity

    Mean change from baseline in the LLBVCA.

    Time frame: 21 Months

07

Study locations

11 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
  • Mid Atlantic Retina
    Cherry Hill, New Jersey 19107, United States
  • New York Ear and Eye Infirmary
    New York, New York 10003-4284, United States
  • Duke Eye Center
    Durham, North Carolina 27705, United States
  • Cumberland Valley Retina Consultants
    Chambersburg, Pennsylvania 17201, United States
  • Gulf Coast Eye Institute
    McAllen, Texas 78503, United States
  • Retina Consultants of Houston
    The Woodlands, Texas 77384, 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 Feb 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04065490
Lead sponsor
LumiThera, Inc.
Responsible party
Sponsor
First posted
Aug 22, 2019
Start date
Sep 1, 2019
Primary completion
Jun 1, 2022 (estimated)
Completion
Jun 1, 2022 (estimated)
Last update
Feb 5, 2021

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 Feb 2021. You cannot join it, but the record below documents what was studied.

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