NCT03878420

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
5 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2019

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2021

Completed
Last Updated

September 2, 2021

Status Verified

August 1, 2021

Enrollment Period

1.9 years

First QC Date

March 15, 2019

Last Update Submit

August 31, 2021

Conditions

Dry Age-related Macular Degeneration

Keywords

Dry AMDPhotobiomodulationVisual AcuityContrast SensitivityOptical Coherence TomographyDrusen

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Visual Acuity

    The primary efficacy endpoint will be the change in BCVA from Baseline to Month 9 as assessed using the ETDRS BCVA chart.

    Month 9

Secondary Outcomes (4)

  • Best Corrected Visual Acuity

    Month 9

  • Contrast Sensitivity

    Month 9

  • Impact on Central Drusen Volume by OCT

    Month 10

  • Impact on Central Drusen Thickness by OCT

    Month 10

Study Arms (2)

PBM Treatment

EXPERIMENTAL

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

Device: Valeda PBM treatment

Sham Treatment

SHAM COMPARATOR

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

Device: Valeda Sham treatment

Interventions

Valeda PBM treatmentDEVICE

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.

PBM Treatment
Valeda Sham treatmentDEVICE

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.

Sham Treatment

Eligibility Criteria

Age50 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Current or history of neovascular maculopathy that includes any of the following:
  • Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
  • Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE)
  • Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)
  • Subretinal and sub-RPE fibrovascular proliferation
  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Institut ophtalmologique de l'Ouest- Clinique jules VERNE

Nantes, France

Location

Universitätsklinikum Freiburg- Klinik für Augenheilkunde

Freiburg im Breisgau, 79106, Germany

Location

Klinik fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein

Kiel, Germany

Location

Universitaetsmedizin Mainz- Augenklinik

Mainz, 55131, Germany

Location

Osprdalr San Raffaele

Milan, Italy

Location

Institut Català de Retina

Barcelona, Spain

Location

James Paget University

Great Yarmouth, NR31 6LA, United Kingdom

Location

Peterborough City Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 36588113DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Valeda Light Delivery System
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2019

First Posted

March 18, 2019

Study Start

February 14, 2019

Primary Completion

January 22, 2021

Study Completion

January 22, 2021

Last Updated

September 2, 2021

Record last verified: 2021-08

Locations

FR(1)DE(3)ES(1)GB(2)IT(1)