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

Completed · Not applicable

Conditions studied: Age Related Macular Degeneration

In brief

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).

Key facts

Study ID

NCT04522999

Run by

LumiThera, Inc.

People needed

15

Starts

2020-08-20

Expected to finish

2021-08-13

Last updated by the study team

2021-09-02

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Perich Eye Center — New Port Richey, Florida, United States

Full record on ClinicalTrials.gov

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