Status:
COMPLETED
Study of Photobiomodulation Effect on Electroretinogram Outcomes in Dry Age-Related Macular Degeneration
Lead Sponsor:
LumiThera, Inc.
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
NA
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 ...
Detailed 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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04522999
Start Date
August 20 2020
End Date
August 13 2021
Last Update
September 2 2021
Active Locations (1)
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1
Perich Eye Center
New Port Richey, Florida, United States, 34655