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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04065490
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : July 10, 2020
Sponsor:
Information provided by (Responsible Party):
LumiThera, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Dry Age-related Macular Degeneration Device: Valeda PBM treatment Device: Valeda Sham treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Valeda Light Delivery System
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : June 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: 21 months ]
    Mean change from baseline in BCVA.


Secondary Outcome Measures :
  1. Contrast Sensitivity [ Time Frame: 21 months ]
    Mean change from baseline (pre-treatment) in contrast sensitivity at 40 cm.

  2. Central Drusen Volume [ Time Frame: 21 Months ]
    Mean change from baseline (pre-treatment) in central Drusen volume.

  3. Central Drusen Thickness [ Time Frame: 21 Months ]
    Mean change from baseline (pre-treatment) in central Drusen thickness.


Other Outcome Measures:
  1. Contrast Sensitivity [ Time Frame: 21 Months ]
    Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.

  2. Visual Function Questionnaire [ Time Frame: 21 Months ]
    Mean change from baseline (pre-treatment) in Visual Function Questionnaire (VFQ-25) composite score.

  3. Reading Speed [ Time Frame: 21 Months ]
    Mean change from baseline (pre-treatment) to Month 21 in monocular reading speed assessed by the Radner Reading Chart.

  4. Geographic Atrophy [ Time Frame: 21 Months ]
    Mean change from baseline in the GA lesion area of the PBM treatment group versus the sham treatment group, as measured by FAF.

  5. Low Luminance- Best Corrected Visual Acuity [ Time Frame: 21 Months ]
    Mean change from baseline in the LLBVCA.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04065490


Contacts
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Contact: Clark Tedford 3605365119 ctedford@lumithera.com
Contact: Cindy Croissant 8583971021 ccroissant@lumithera.com

Locations
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United States, California
Retina Vitreous Associates Medical Group Recruiting
Beverly Hills, California, United States, 90211
Contact: Janet Kurokouchi    310-289-2478 ext 3    JKurokouchi@laretina.com   
Contact: Raquel Matsumoto       RMatsumoto@laretina.com   
Principal Investigator: David Boyer, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94303
Contact: Lisa Greer    650-725-9184    lgreer7@stanford.edu   
Contact: Jennifer Yarp    1-650-497-5942    jyarp@stanford.edu   
Principal Investigator: Diana Do, MD         
United States, Florida
Florida Eye Clinic Recruiting
Altamonte Springs, Florida, United States, 32701
Contact: Jan Noemer    407-775-7495    jan.noemer@floridaeyeclinic.com   
Principal Investigator: Samantha Xavier, MD         
United States, Maryland
Cumberland Valley Retina Consultants Recruiting
Hagerstown, Maryland, United States, 21749
Contact: Brittany Carson       BrittanyC@retinacare.net   
Contact    (301) 665-1712 ext 1025      
Principal Investigator: Allen Hu, MD         
United States, New York
New York Ear and Eye Infirmary Recruiting
New York, New York, United States, 10003-4284
Contact: Katy Tai    212-979-4671    KTai@NYEE.EDU   
Contact: Melissa Tunik       MTunik@nyee.edu   
Principal Investigator: Richard Rosen, MD         
United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Alice Ventura    919-681-6585    alice.ventura@duke.edu   
Contact: Lori Foraker    919-668-1859    loretta.foraker@duke.edu   
Principal Investigator: Nora Lad, MD         
United States, Pennsylvania
Cumberland Valley Retina Consultants Recruiting
Chambersburg, Pennsylvania, United States, 17201
Contact: Renee McGown    301-665-1712 ext. 1033    ReneeM@retinacare.net   
Contact: Carson    301-665-1712 ext. 1025    BrittanyC@retinacare.net   
Principal Investigator: David Warrow, MD         
Mid Atlantic Retina Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Michele Formoso       Research@midatlanticretina.com   
Principal Investigator: Allen C. Ho, MD         
United States, Texas
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77384
Contact: Kameron Boren    936-273-6620    kameron.boren@houstonretina.com   
Contact: Melisa Bocanegra    936-273-6620    melisa.bocanegra@houstonretina.com   
Principal Investigator: David Brown, MD         
Gulf Coast Eye Institute Recruiting
McAllen, Texas, United States, 78503
Contact: Yesenia Salinas, AA    956-631-8875 ext 157    ysalinas@vritx.com   
Contact: Angelina Garza, BS    956-631-8875 ext 118    a_garza@vritx.com   
Principal Investigator: Victor Gonzalez, MD         
United States, Washington
Retina Center Northwest Recruiting
Silverdale, Washington, United States, 98383
Contact: Jillayne Newquist    360-307-0300    jillayne@retinacenternw.com   
Principal Investigator: Todd Schneiderman, MD         
Sponsors and Collaborators
LumiThera, Inc.
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Responsible Party: LumiThera, Inc.
ClinicalTrials.gov Identifier: NCT04065490    
Other Study ID Numbers: CSP005
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by LumiThera, Inc.:
Dry age-related macular degeneration
Photobiomodulation
Visual Acuity
Contrast Sensitivity
Drusen
Optical coherence tomography
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases