Search / Trial NCT06229665

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

Launched by LUMITHERA, INC. · Jan 19, 2024

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Trial Information

Current as of December 22, 2024

Active, not recruiting

Keywords

Dry Age Related Macular Degeneration Photobiomodulation

ClinConnect Summary

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 additi...

Gender

ALL

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

About Lumithera, Inc.

Lumithera, Inc. is a pioneering medical technology company dedicated to advancing therapeutic solutions for retinal diseases. With a focus on innovative light-based treatments, Lumithera harnesses the power of photobiomodulation to enhance visual function and improve patient outcomes. The company is committed to conducting rigorous clinical trials to validate the safety and efficacy of its products, ultimately aiming to address unmet needs in the field of ophthalmology. Through collaboration with healthcare professionals and research institutions, Lumithera strives to transform the landscape of vision care and empower patients with effective treatment options.

Locations

Palo Alto, California, United States

Beverly Hills, California, United States

Altamonte Springs, Florida, United States

Silverdale, Washington, United States

Durham, North Carolina, United States

Hagerstown, Maryland, United States

Cherry Hill, New Jersey, United States

New York, New York, United States

Mcallen, Texas, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0