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The EUROLIGHT study is being conducted to collect real life data for the safety and effectiveness of PBM in dry AMD, in routine clinical practice both retrospectively and prospectively.
This is a multi-center, retrospective and prospective registry study on the use of the Valeda® PBM system as a treatment for visual improvement in participants with dry AMD. The target is at least 25 participants/site in up to 20 participating sites in Europe.
Participants will or will have received nine non-invasive, short treatments over three to four weeks starting at Baseline (BL), with up to five additional rounds of treatment every four to six months, or as determined by the Investigator.
Standard visual outcome measurements collected will include visual acuity (either ETDRS BCVA or LogMAR) prior to and following treatment. OCT and Fundus Autofluorescence (FAF) imaging of the retina should be taken at screening, and after each round of treatment. As this is a registry study, missing
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Photobiomodulation (PBM) | Valeda Light Delivery System The Valeda Light Delivery System will deliver two alternating and sequential treatments of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds; and 660 nm for 90 seconds, or a total of 180 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valeda Light Delivery System | Device | The Valeda Light Delivery System will deliver two alternating and sequential treatments of 590 nm and 850 nm for 35 seconds, or a total of 70 seconds; and 660 nm for 90 seconds, or a total of 180 seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Best-Corrected Visual Acuity (BCVA) | Mean change from baseline in BCVA. | 31 months |
| Measure | Description | Time Frame |
|---|---|---|
| OCT Imaging | OCT instruments will be used to image the retina for diagnosis and anatomical assessments (general retinal thickness and drusen volume) of dry AMD pathology | 31 months |
| FAF Imaging |
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Inclusion Criteria:
Exclusion Criteria:
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The patient population for this study will consist of a target of at least 25 male and female participants per site of any ethnic background and with a diagnosis of dry AMD by the Investigator or confirmed by the Investigator. The participant must meet all the inclusion criteria, have none of the exclusion criteria, and give their written Informed Consent to participate in this clinical study.
Only if the participant is interested in participating, s/he would be given the option to sign the study consent and start the study procedures, or if retrospectively signing the informed consent form, have their data used in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie Tedford, PhD | Contact | 3605365122 | setedford@lumithera.com |
| Name | Affiliation | Role |
|---|---|---|
| Cindy Croissant, MBA | LumiThera, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Recruiting | Oslo | Norway |
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FAF is used to evaluate both hypoautofluorescence (GA) and hyperauto-fluorescence and drusen byproducts, the deposition of lipofuscin in the retinal pigment epithelium D3001-CSP006 14MAY2023 V2.0 CONFIDENTIAL Page 22 of 42 (RPE).
| 31 months |