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

NCT04522999 | Completed FDA Device

• 1 other identifier: CSP007
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• ERG function

  ERG assessments (Multifocal ERG (mfERG), Photopic Negative Response (PhNR), Multi-luminance Flicker ERG (ML-FERG) and Fixed-luminance Flicker ERG (FL-FERG)) will provide an output of retinal function.

  3 months

Other Outcomes (2)

• ETDRS Visual Acuity

  3 months

• Mars Contrast Sensitivity

  3 months

Study Arms (1)

Photobiomodulation

EXPERIMENTAL

Valeda™ Light Delivery System

Device: Photobiomodulation

Interventions

Photobiomodulation DEVICE

The Valeda™ Light Delivery System

Photobiomodulation

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• LumiThera, Inc.: lead

Study Sites (1)

Perich Eye Center

New Port Richey, Florida, 34655, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 21, 2020
• Study Start: August 20, 2020
• Primary Completion: August 13, 2021
• Study Completion: August 13, 2021
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

US (1)