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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03878420
Recruitment Status : Completed
First Posted : March 18, 2019
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
LumiThera, Inc.

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 18, 2019
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE February 14, 2019
Actual Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
Best Corrected Visual Acuity [ Time Frame: Month 9 ]
The primary efficacy endpoint will be the change in BCVA from Baseline to Month 9 as assessed using the ETDRS BCVA chart.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Best Corrected Visual Acuity [ Time Frame: Month 9 ]
    The first of the secondary analyses will test the difference between the sham-treated and PBM-treated subjects in mean change from baseline (pre-treatment) to Month 9 in BCVA.
  • Contrast Sensitivity [ Time Frame: Month 9 ]
    The second of the secondary analyses will test the difference between the sham-treated and PBM-treated subjects in mean change from baseline (pre-treatment) to Month 9 in contrast sensitivity at 18 cycles/degree (CPD).
  • Impact on Central Drusen Volume by OCT [ Time Frame: Month 10 ]
    The analyses will first examine change from the screening visit in central Drusen volume
  • Impact on Central Drusen Thickness by OCT [ Time Frame: Month 10 ]
    The analyses will then examine change from the screening visit in central Drusen Thickness
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE II)
Official Title  ICMJE 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 II)
Brief Summary This LIGHTSITE II 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.
Detailed Description

This 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. The target enrollment is 96 subjects in up to 10 centers in Europe, randomized at a 1:2 ratio into 2 groups: Sham Treatment (S-1) and PBM Treatment (T-2). Once 96 subjects have been enrolled in the study, if there are less than 144 eyes that qualify for the study, additional subjects will be enrolled until 144 eyes have been included in the study.

S-1 will receive 3 sham treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. T-2 will receive 3 PBM treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. Each treatment series will total 9 treatments. Neither the subject nor the study staff will know which treatment the subject has been assigned.

Subjects will receive standard visual outcome measurements including Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA, CSV-1000E contrast sensitivity (CS) and the Radner Reading Test prior to and following each treatment series as well as eye exams, fundus photographs, Heidelberg OCT and FAF imaging and optional Optos Ultra Wide Field (UWF) imaging of the retina at selected time intervals. Subjects will also complete the Visual Function Questionnaire 25 (VFQ-25) at selected time intervals.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Valeda Light Delivery System
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Age-related Macular Degeneration
Intervention  ICMJE
  • Device: Valeda PBM treatment
    The Valeda Light Delivery System delivers 590, 660 and 850 nm wavelengths of light to the study eye. The Valeda Light Delivery System will treat through the open eyelid with the 590 nm and 850 nm wavelengths together. The 660 nm wavelength will be treated through the closed eyelid.
  • Device: Valeda Sham treatment
    The sham mode emits an approximate 100x reduction in the highest dose for the 660 nm wavelengths as compared to the treatment mode, producing a slightly duller light. The 850 nm (NIR) wavelength (which is not visible light) is not provided in the sham treatment.
Study Arms  ICMJE
  • Experimental: PBM Treatment
    The Valeda™ Light Delivery System will deliver 590, 660 and 850 nm wavelengths together.
    Intervention: Device: Valeda PBM treatment
  • Sham Comparator: Sham Treatment
    The Valeda™ Light Delivery System will deliver non-effective treatment of the 590 and 660 nm wavelengths together.
    Intervention: Device: Valeda Sham treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2021)
44
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2019)
144
Actual Study Completion Date  ICMJE January 22, 2021
Actual Primary Completion Date January 22, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female at least 50 years of age at Screening visit
  • Subjects with 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 is outside the letter score by up to two letters at Baseline, the subject may be entered in the study.
  • Subjects with a diagnosis of dry AMD as defined by the presence of drusen (regular or reticular pseudodrusen) and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or Heidelberg FAF
  • Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
  • Subject is informed of the nature of this study and has provided written informed consent in accordance with institutional, local and national regulatory guidelines

Exclusion Criteria:

  • Current or history of neovascular maculopathy that includes any of the following:

    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)
  • Presence of center involving GA within the central ETDRS 1 mm diameter at Screening
  • 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.
  • 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
  • Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
  • 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)
  • Has a 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 5 years other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ
  • Is non-ambulatory
  • Presence or history of known light sensitivity to yellow light, red light, or near infrared radiation (NIR), or if there is a history of light activated CNS disorders (e.g. epilepsy, migraine)
  • Use of any photosensitizing agent (e.g. topicals, injectables) within 30 days of treatment without consulting subject's physician
  • History of drug, alcohol or substance abuse within 3 months prior to Screening
  • Has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
  • 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.
  • Has received Low Vision Rehab/Therapy within 30 days prior to Screening or intends to receive during the study
  • In the opinion of the Investigator, is unlikely to comply with the study protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 120 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03878420
Other Study ID Numbers  ICMJE CSP003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party LumiThera, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE LumiThera, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account LumiThera, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP