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

A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE III)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dry Age-related Macular Degeneration
• Intervention / Treatment: Device: Valeda PBM treatment; Device: Valeda Sham treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Retina Vitreous Associates Medical Group
    • Palo Alto, California, United States, 94303
      • Stanford University
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • Florida Eye Clinic
  • Maryland
    • Hagerstown, Maryland, United States, 21749
      • Cumberland Valley Retina Consultants
  • New Jersey
    • Cherry Hill, New Jersey, United States, 19107
      • Mid Atlantic Retina
  • New York
    • New York, New York, United States, 10003-4284
      • New York Ear and Eye Infirmary
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Eye Center
  • Pennsylvania
    • Chambersburg, Pennsylvania, United States, 17201
      • Cumberland Valley Retina Consultants
  • Texas
    • McAllen, Texas, United States, 78503
      • Gulf Coast Eye Institute
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Houston
  • Washington
    • Silverdale, Washington, United States, 98383
      • Retina Center Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PBM Treatment; The Valeda™ Light Delivery System	Device: Valeda PBM treatment; The Valeda Light Delivery System
Sham Comparator: Sham Treatment; The Valeda™ Light Delivery System non-effective treatment	Device: Valeda Sham treatment; The sham mode of the Valeda Light Delivery System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best Corrected Visual Acuity	Mean change from baseline in BCVA.	21 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Sensitivity	Mean change from baseline (pre-treatment) in contrast sensitivity at 40 cm.	21 months
Central Drusen Volume	Mean change from baseline (pre-treatment) in central Drusen volume.	21 Months
Central Drusen Thickness	Mean change from baseline (pre-treatment) in central Drusen thickness.	21 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast Sensitivity	Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.	21 Months
Visual Function Questionnaire	Mean change from baseline (pre-treatment) in Visual Function Questionnaire (VFQ-25) composite score.	21 Months
Reading Speed	Mean change from baseline (pre-treatment) to Month 21 in monocular reading speed assessed by the Radner Reading Chart.	21 Months
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.	21 Months
Low Luminance- Best Corrected Visual Acuity	Mean change from baseline in the LLBVCA.	21 Months

Collaborators and Investigators

• Sponsor: LumiThera, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Contrast Sensitivity; Photobiomodulation; Visual Acuity; Drusen; Dry age-related macular degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: CSP005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes