Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration (ELECTROLIGHT)

LumiThera

Status

Completed

Conditions

Age Related Macular Degeneration

Treatments

Device: Photobiomodulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT04522999

CSP007

Details and patient eligibility

About

To evaluate the ability of Photobiomodulation (PBM) treatment using the Valeda® Light Delivery System to improve Electroretinogram (ERG) outcomes in subjects with dry Age-related Macular Degeneration (AMD).

Full description

This study is an open label, prospective pilot study to evaluate retinal function after PBM treatment in eyes with dry AMD using ERG. The target enrollment is 15 subjects in up to two sites in the US. All subjects will receive PBM Treatment.

Subjects will receive three PBM treatments per week for three weeks for a total of nine sessions over 3 weeks.

The primary analysis will examine multi-focal ERG function changes from baseline to Month 1. Secondary analyses will examine multi-focal ERG function change from baseline to Month 3 and 6. Other endpoints will include other functions of ERG, ETDRS Visual Acuity, Contrast Sensitivity, Perimetry, Color Vision test and the Amsler grid test.

Enrollment

15 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female at least 50 years of age at Screening visit
ETDRS BCVA letter score of between 50* and 75* (Snellen equivalent of 20/100 to 20/32)
Diagnosis of dry AMD
Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
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
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)
Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s)
Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
Visually significant disease in any ocular structure apart from dry AMD
Serious medical illness that will prevent the subject from performing study activities
Presence of or history of malignancy within the past 5 years
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)
History of neurologic condition known to affect visual function
History of drug, alcohol or substance abuse within 3 months prior to Screening
Participation in any other clinical study at time of screening, or has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
In the opinion of the Investigator, is unlikely to comply with the study protocol