Dry Age-related Macular DegenerationPhase 2/3NCT06229665
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITEIIIB)
A Phase 2/3 study testing Valeda Light Delivery System in people with Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 7 sites in United States.
Trial summary
This study is an open-label, prospective, multi-center extension study on the continued use of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) that participated in the CSP005 LIGHTSITE III study. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Dry Age-related Macular Degeneration
- What is being tested?
- Valeda Light Delivery System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 7 sitesUnited States
- Study dates
- 25 Oct 2023to 1 Jun 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Entry Criteria: Inclusion Criteria (each eye qualifies for the study independently):
- Participation in and completion of LIGHTSITE III study.
- Eye was randomized in LIGTHTSITE III study or diagnosis of dry AMD as defined by the presence of the following: Drusen that are intermediate in size or larger (63 μm or larger in diameter) with at least a few (3) being regular drusen and not pseudodrusen and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or FAF. The reading center will confirm criteria for NEW EYES only (i.e., those not randomized in LIGHTSITE III) with one of the following: 1) LIGHTSITE IIIB Screening Visit images (Screening visit only performed if there are >90 days between LIGHTSITE III Mo 24 visit and the start of the LIGHTSITE IIIB study) or 2) LIGHTSITE III Mo 24 images (if <90 days passes between LIGHTSITE III Mo 24 and the start of the LIGHTSITE IIIB study).
- 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 (each eye qualifies for the study independently):
- Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center):
- Choroidal neovascularization (CNV) defined as pathologic angiogenesis originating from the choroidal vasculature that extends through a defect in Bruch's membrane
- Serous and/or hemorrhagic detachment of the neurosensory retina or retinal pigment epithelial (RPE)
- Retinal hard exudates (a secondary phenomenon resulting from chronic intravascular leakage)
- Subretinal and sub-RPE fibrovascular proliferation
- Disciform scar (subretinal fibrosis)
- Media opacities, including cataracts, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require cataract surgery in the study eye in the next 12 months.
- Posterior capsule opacification, which might interfere with visual acuity or imaging in the study eye(s). Subjects should not be entered if there is likelihood that they will require surgery in the study eye in the next 12 months.
- Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three months prior to Baseline
- Ocular disorder or disease that partially or completely obstructs the pupil (e.g. posterior synechia in uveitis)
- Visually significant disease in any ocular structure apart from dry AMD (e.g. diabetic macular edema, glaucoma (using >2 eye drop medications, uncontrolled IOP and/or central/paracentral visual field loss), glaucoma surgery, active uveitis, active vitreous disease, intraocular tumor, retinal vascular diseases)
- Ocular disorder or disease other than dry AMD that could cause drusen (glomerulonephritis Type 2, Autosomal dominant drusen), GA (North Carolina dystrophy) or mitochondrial diseases (parafoveal petaloid GA, Stargardt disease)
- Presence or history of disease or condition affecting functional vision without obvious structural abnormalities (e.g. amblyopia, stroke, nystagmus)
- Serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study
- Presence of or history of malignancy within the past 3 years other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ
- Is non-ambulatory
- 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)
- Use of any photosensitizing agent (e.g. topicals, injectables, oral) activated by the Valeda Light Delivery System wavelengths within 30 days of treatment without consulting subject's physician
- History of drug, alcohol or substance abuse within 3 months prior to Baseline
- Participation in any other clinical study at time of Baseline, or has received an investigational drug or treatment with an investigational device within 3 months prior to Baseline
- If on any anti-oxidant or vitamin Age-Related Eye Disease Study (AREDS) supplement for dry AMD, has not been stabilized for a minimum of 1 month prior to Baseline. Subjects are considered to be stable if they are taking the AREDS supplements consistently as prescribed by their treating doctor.
- Has received Low Vision Rehab/Therapy within 30 days prior to Baseline or intends to receive during the study
- Has an open sore(s) that may come in contact with the Valeda System, has periorbital skin erythema or is prone to such conditions with exposure to light.
- In the opinion of the Investigator, is unlikely to comply with the study protocol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Florida Eye Clinic
Altamonte Springs, Florida, 32701
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21749
Gulf Coast Eye Institute
McAllen, Texas, 78503
New York Ear and Eye Infirmary
New York, New York, 10003-4284
Stanford University
Palo Alto, California, 94303
Retina Center Northwest
Silverdale, Washington, 98383
About this study
Official title: An Open-Label, Prospective, Multi-Center Extension Study to Assess the Long-Term Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE IIIB)
This study is an open-label, prospective, multi-center extension study on the continued use of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) that participated in the CSP005 LIGHTSITE III study.
Read the detailed description
This study is an open-label, prospective, multi-center study on the use of PBM as a treatment for visual impairment in subjects with dry AMD. Subjects diagnosed with dry AMD who meet all inclusion criteria and have none of the exclusion criteria will be eligible to participate in this clinical study. All subjects will be treated with the Valeda Light Delivery System and will receive PBM treatment for a total of 9 treatments over a three to five-week period (3 times per week for 3 weeks is preferable). There will be a re-treatment period starting at the 4-month time point to include 9 additional treatment visits, to be repeated again at 8 months and 12 months. LumiThera will use settings for the 3 wavelengths that were used in the CSP005 study. The subject population for this study will consist of all subjects that completed the CSP005 study, meet the inclusion/exclusion criteria for the CSP010 study, are interested in study participation and have signed the Informed Consent Form.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- Valeda Light Delivery System
- Keywords
- dry age-related macular degeneration, photobiomodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valeda Light Delivery SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation (PBM) | Experimental | 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. Receives: Device: Valeda Light Delivery System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA)
Mean change from baseline in BCVA.
Measured: 12 months
Secondary outcomes (3)
Low Luminance BCVA
Mean change from baseline in the LLBVCA.
Measured: 12 months
Contrast Seensitivity
Mean change from baseline (pre-treatment) in contrast sensitivity at 80 cm and 120 cm.
Measured: 12 months
Geographic Atrophy (GA)
Number of new onset GA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start25 Oct 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Valeda Light Delivery System
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LumiThera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229665
- Sponsor's protocol ID
- CSP010
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Prospective, Multi-Center Extension Study to Assess the Long-Term Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE IIIB)
- ClinicalTrials.gov ID
- NCT06229665
- Acronym / sponsor ID
- CSP010
- Conditions
- Dry Age-related Macular Degeneration
- Keywords
- dry age-related macular degeneration, photobiomodulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- LumiThera, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, prospective, multi-center extension study on the continued use of photobiomodulation (PBM) in subjects with dry age-related macular degeneration (AMD) that participated in the CSP005 LIGHTSITE III study.
Detailed description
This study is an open-label, prospective, multi-center study on the use of PBM as a treatment for visual impairment in subjects with dry AMD. Subjects diagnosed with dry AMD who meet all inclusion criteria and have none of the exclusion criteria will be eligible to participate in this clinical study. All subjects will be treated with the Valeda Light Delivery System and will receive PBM treatment for a total of 9 treatments over a three to five-week period (3 times per week for 3 weeks is preferable). There will be a re-treatment period starting at the 4-month time point to include 9 additional treatment visits, to be repeated again at 8 months and 12 months. LumiThera will use settings for the 3 wavelengths that were used in the CSP005 study. The subject population for this study will consist of all subjects that completed the CSP005 study, meet the inclusion/exclusion criteria for the CSP010 study, are interested in study participation and have signed the Informed Consent Form.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Valeda Light Delivery System
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation (PBM) | Experimental | Device: Valeda Light Delivery SystemThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valeda Light Delivery SystemThe 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. | Device | Photobiomodulation (PBM) |
Primary outcome
Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA)
Time frame: 12 months
Mean change from baseline in BCVA.
3 secondary outcomes
Low Luminance BCVA
Time frame: 12 months
Contrast Seensitivity
Time frame: 12 months
Geographic Atrophy (GA)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Valeda Light Delivery System in people with Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.