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

NCT06229665 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: CSP010
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Dry Age-related Macular Degeneration

Keywords

dry age-related macular degeneration; photobiomodulation

Outcome Measures

Primary Outcomes (1)

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

  Mean change from baseline in BCVA.

  12 months

Secondary Outcomes (3)

• Low Luminance BCVA

  12 months

• Contrast Seensitivity

  12 months

• Geographic Atrophy (GA)

  12 months

Study Arms (1)

Photobiomodulation (PBM)

EXPERIMENTAL

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

Valeda Light Delivery System DEVICE

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.

Photobiomodulation (PBM)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in and completion of LIGHTSITE III study.
• 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).
• Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
• Informed of the nature of this study and has provided written, informed consent in accordance with institutional, local and national regulatory guidelines

You may not qualify if:

• Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center):
• Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
• Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE)
• Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)
• Subretinal and sub-RPE fibrovascular proliferation
• Disciform scar (subretinal fibrosis)
• 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.
• 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.
• Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three months prior to Baseline
• Ocular disorder or disease that partially or completely obstructs the pupil (e.g. posterior synechia in uveitis)
• 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)
• 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)
• Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus)
• 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
• 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

Sponsors & Collaborators

• LumiThera, Inc.: lead
• National Eye Institute (NEI): collaborator

Study Sites (7)

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Stanford University

Palo Alto, California, 94303, United States

Location

Florida Eye Clinic

Altamonte Springs, Florida, 32701, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21749, United States

Location

New York Ear and Eye Infirmary

New York, New York, 10003-4284, United States

Location

Gulf Coast Eye Institute

McAllen, Texas, 78503, United States

Location

Retina Center Northwest

Silverdale, Washington, 98383, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Valeda Light Delivery System

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 29, 2024
• Study Start: October 25, 2023
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)