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

NCT ID: NCT03878420

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-14
• Study Completion Date: 2021-01-22

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.

Conditions

Dry Age-related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PBM Treatment

The Valeda™ Light Delivery System will deliver 590, 660 and 850 nm wavelengths together.

Group Type: EXPERIMENTAL

Valeda PBM treatment

Intervention Type: DEVICE

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.

Sham Treatment

The Valeda™ Light Delivery System will deliver non-effective treatment of the 590 and 660 nm wavelengths together.

Group Type: SHAM_COMPARATOR

Valeda Sham treatment

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LumiThera, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut ophtalmologique de l'Ouest- Clinique jules VERNE

Nantes, , France

Universitätsklinikum Freiburg- Klinik für Augenheilkunde

Freiburg im Breisgau, , Germany

Klinik fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein

Kiel, , Germany

Universitaetsmedizin Mainz- Augenklinik

Mainz, , Germany

Osprdalr San Raffaele

Milan, , Italy

Institut Català de Retina

Barcelona, , Spain

James Paget University

Great Yarmouth, , United Kingdom

Peterborough City Hospital

Peterborough, , United Kingdom

Countries

France; Germany; Italy; Spain; United Kingdom

References

Burton B, Parodi MB, Jurgens I, Zanlonghi X, Hornan D, Roider J, Lorenz K, Munk MR, Croissant CL, Tedford SE, Walker M, Ruckert R, Tedford CE. LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration. Ophthalmol Ther. 2023 Apr;12(2):953-968. doi: 10.1007/s40123-022-00640-6. Epub 2023 Jan 2.

Reference Type: DERIVED

PMID: 36588113 (View on PubMed)

Other Identifiers

CSP003

Identifier Type: -

Identifier Source: org_study_id