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Dry Age-related Macular DegenerationPhase 2/3NCT06229665

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

A Phase 2/3 study testing Valeda Light Delivery System in people with Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 7 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Dry Age-related Macular Degeneration
What is being tested?
Valeda Light Delivery System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
7 sitesUnited States
Study dates
25 Oct 2023to 1 Jun 2025
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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):
  2. Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
  3. Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE)
  4. Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)
  5. Subretinal and sub-RPE fibrovascular proliferation
  6. Disciform scar (subretinal fibrosis)
  7. 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.
  8. 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.
  9. Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three months prior to Baseline
  10. Ocular disorder or disease that partially or completely obstructs the pupil (e.g. posterior synechia in uveitis)
  11. 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)
  12. 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)
  13. Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus)
  14. 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
  15. 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
  16. Is non-ambulatory
  17. 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)
  18. 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
  19. History of drug, alcohol or substance abuse within 3 months prior to Baseline
  20. 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
  21. 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.
  22. Has received Low Vision Rehab/Therapy within 30 days prior to Baseline or intends to receive during the study
  23. 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.
  24. In the opinion of the Investigator, is unlikely to comply with the study protocol

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites
  • Florida Eye Clinic

    Altamonte Springs, Florida, 32701

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21749

  • Gulf Coast Eye Institute

    McAllen, Texas, 78503

  • New York Ear and Eye Infirmary

    New York, New York, 10003-4284

  • Stanford University

    Palo Alto, California, 94303

  • Retina Center Northwest

    Silverdale, Washington, 98383

Other trials in United States

About this study

Official title: An Open-Label, Prospective, Multi-Center Extension Study to Assess the Long-Term Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE IIIB)

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.

Being tested
Valeda Light Delivery System
Keywords
dry age-related macular degeneration, photobiomodulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Valeda Light Delivery SystemDevice

    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.

Study groups in NCT06229665
Study groupRoleWhat they receive
Photobiomodulation (PBM)ExperimentalThe 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.
Receives: Device: Valeda Light Delivery System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Mean change from baseline in BCVA.

    Measured: 12 months

Secondary outcomes (3)
  1. Low Luminance BCVA

    Mean change from baseline in the LLBVCA.

    Measured: 12 months

  2. Contrast Seensitivity

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

    Measured: 12 months

  3. Geographic Atrophy (GA)

    Number of new onset GA

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start25 Oct 2023
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Valeda Light Delivery System
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06229665
Sponsor's protocol ID
CSP010
Status last verified
Apr 2024
First submitted
19 Jan 2024
Last updated
3 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Valeda Light Delivery System in people with Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.

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