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

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

Tracking Information

• First Submitted Date: March 15, 2019
• First Posted Date: March 18, 2019
• Last Update Posted Date: September 2, 2021
• Actual Study Start Date: February 14, 2019
• Actual Primary Completion Date: January 22, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE II)
• 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 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Dry Age-related Macular Degeneration

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 31, 2021): 44
• Original Estimated Enrollment (submitted: March 15, 2019): 144
• Actual Study Completion Date: January 22, 2021
• Actual Primary Completion Date: January 22, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 50 Years to 120 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Germany, Italy, Spain, United Kingdom

Administrative Information

• NCT Number: NCT03878420
• Other Study ID Numbers: 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

• Plan to Share IPD: Undecided

• Current Responsible Party: LumiThera, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: LumiThera, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: LumiThera, Inc.
• Verification Date: August 2021