Dry Age-related Macular DegenerationNCT04065490
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE III)
A study testing Valeda Light Delivery System in people with Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 10 sites in United States.
Trial summary
This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD. Alcon Research, LLC, acquired LumiThera in September 2025. 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?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 10 sitesUnited States
- Study dates
- 23 Sep 2019to 1 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- 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). *If the subject meets this criterion at the Screening Visit, but the Baseline BCVA letter score is between 48 and 77, the subject may be entered in the study.
- 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, to be confirmed by the reading center
- 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
Who cannot join
- 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)
Show all 25Show fewer
- Presence of center involving GA within the central ETDRS 1 mm diameter at Screening, to be confirmed by the reading center
- 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 24 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 24 months.
- Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
- 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 5 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) within 30 days of treatment without consulting subject's physician
- History of drug, alcohol or substance abuse within 3 months prior to Screening
- Has received an investigational drug or treatment with an investigational device within 3 months prior to Screening
- 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 Screening. 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 Screening 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
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Florida Eye Clinic
Altamonte Springs, Florida, 32701
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Cumberland Valley Retina Consultants
Chambersburg, Pennsylvania, 17201
Mid Atlantic Retina
Cherry Hill, New Jersey, 19107
Duke Eye Center
Durham, North Carolina, 27705
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: A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE III)
This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.
Alcon Research, LLC, acquired LumiThera in September 2025.
Read the detailed description
This study is a double-masked, sham-controlled, parallel design prospective, multi-site study on the use of photobiomodulation (PBM) as a treatment for visual impairment in subjects with dry AMD. Subjects will receive repeated sham or PBM treatments at several time-points throughout the 2-year study.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- Valeda Light Delivery System, Valeda Light Delivery System Sham Mode
- Keywords
- Dry age-related macular degeneration, Photobiomodulation, Visual Acuity, Contrast Sensitivity, Drusen, Optical coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valeda Light Delivery SystemDevice
Light delivery system that produces multi-wavelength LED treatment at 590, 660 and 850 nanometers.
Valeda Light Delivery System Sham ModeDevice
Sham light delivery system that emits an approximate 50 times and 100 times reduction in treatment dose for the 590 and 660 nm wavelengths respectively and no emission of the 850 nm wavelength.
| Study group | Role | What they receive |
|---|---|---|
| PBM Treatment | Experimental | Valeda Light Delivery System: 3 PBM treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4, 8, 12, 16 and 20. Receives: Device: Valeda Light Delivery System |
| Sham Treatment | Sham comparator | Valeda Light Delivery System Sham Mode: 3 sham treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4, 8, 12, 16 and 20. Receives: Device: Valeda Light Delivery System Sham Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Best Corrected Visual Acuity (Letters Read) at Month 21
Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Each line on the chart had exactly five letters, uniform spacing, and a proportional decrease in letter size, providing an equal level of difficulty for every single line read by the patient. A positive change in number of letters read indicates an improvement in visual acuity.
Measured: Baseline (Day 0, pretreatment), Month 21
Secondary outcomes (3)
Mean Change From Baseline in Contrast Sensitivity (40 Centimeters) at Month 21
The Mars Contrast Sensitivity Test (Mars CS Test) is a vision test that measures how well a person can see objects that do not stand out clearly from their background. The test consisted of a set of charts that scored visual function from 0 (profound loss) to 1.92 (normal) vision at a distance of 40 centimeters. A positive change value indicates an improvement.
Measured: Baseline (Day 0, pretreatment), Month 21
Mean Change From Baseline in Central Drusen Volume at Month 21
Drusen are yellowish deposits of lipids, cholesterol, and cellular waste products that accumulate underneath the retinal pigment epithelium (RPE). They are one of the hallmark signs of age-related macular degeneration (AMD). Central drusen volume is a measurement of the total amount of drusen material in the center of the retina (the macula). Central drusen volume was measured by optical coherence tomography and fundus autofluorescence imaging. A smaller change represents lesser damage to the retina.
Measured: Baseline (Day 0, pretreatment), Month 21
Mean Change From Baseline in Low Luminance Best Corrected Visual Acuity (LLBCVA) at Month 21
Low Luminance Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. A 2.0 log unit neutral density filter was added to create the low lighting conditions. Each line on the chart had exactly five letters, uniform spacing, and a proportional decrease in letter size, providing an equal level of difficulty for every single line read by the patient. A positive change in number of letters read indicates an improvement in visual acuity.
Measured: Baseline (Day 0, pretreatment), Month 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start23 Sep 2019
- Primary completion24 Jan 2023
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Valeda Light Delivery System
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiThera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Director, Clinical Trial Management, Surgical, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065490
- Sponsor's protocol ID
- CSP005
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2019
- Last updated
- 8 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Jaffe GJ, Boyer D, Hu A, Warrow D, Xavier S, Gonzalez V, Lad E, Rosen RB, Do DV, Schneiderman T, Ho AC, Munk MR, Tedford SE, Croissant CL, Ruckert R, Lavin PT, Tedford CE. LONG-TERM EFFICACY AND SAFETY OF PHOTOBIOMODULATION IN DRY AGE-RELATED MACULAR DEGENERATION (LIGHTSITE III: 24-MONTH ANALYSIS). Retina. 2026 May 1;46(5):783-795. doi: 10.1097/IAE.0000000000004822.
PubMed 41791029
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Photobiomodulation (PBM) in Subjects With Dry Age-Related Macular Degeneration (AMD) (LIGHTSITE III)
- ClinicalTrials.gov ID
- NCT04065490
- Acronym / sponsor ID
- CSP005
- Conditions
- Dry Age-related Macular Degeneration
- Keywords
- Dry age-related macular degeneration, Photobiomodulation, Visual Acuity, Contrast Sensitivity, Drusen, Optical coherence tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- LumiThera, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Posted 8 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This LIGHTSITE III study is a double-masked, sham-controlled, parallel design, prospective multi-site study for the use of PBM as a treatment for visual impairment in subjects with dry AMD.
Alcon Research, LLC, acquired LumiThera in September 2025.
Detailed description
This study is a double-masked, sham-controlled, parallel design prospective, multi-site study on the use of photobiomodulation (PBM) as a treatment for visual impairment in subjects with dry AMD. Subjects will receive repeated sham or PBM treatments at several time-points throughout the 2-year study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Valeda Light Delivery System
| Arm | Type | Receives |
|---|---|---|
| PBM Treatment | Experimental | Device: Valeda Light Delivery SystemValeda Light Delivery System: 3 PBM treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4, 8, 12, 16 and 20. |
| Sham Treatment | Sham comparator | Device: Valeda Light Delivery System Sham ModeValeda Light Delivery System Sham Mode: 3 sham treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4, 8, 12, 16 and 20. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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). *If the subject meets this criterion at the Screening Visit, but the Baseline BCVA letter score is between 48 and 77, the subject may be entered in the study.
- 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, to be confirmed by the reading center
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
Key exclusion criteria (25 listed)
- Current or history of neovascular maculopathy that includes any of the following (to be confirmed by the reading center):
- Presence of center involving GA within the central ETDRS 1 mm diameter at Screening, to be confirmed by the reading center
- 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 24 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 24 months.
- Invasive eye surgery (e.g. cataract, capsulotomy) on a qualifying eye within three 3 months prior to Screening
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 SystemLight delivery system that produces multi-wavelength LED treatment at 590, 660 and 850 nanometers. | Device | PBM Treatment |
| Valeda Light Delivery System Sham ModeSham light delivery system that emits an approximate 50 times and 100 times reduction in treatment dose for the 590 and 660 nm wavelengths respectively and no emission of the 850 nm wavelength. | Device | Sham Treatment |
Primary outcome
Mean Change From Baseline in Best Corrected Visual Acuity (Letters Read) at Month 21
Time frame: Baseline (Day 0, pretreatment), Month 21
Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) letter charts. Each line on the chart had exactly five letters, uniform spacing, and a proportional decrease in letter size, providing an equal level of difficulty for every single line read by the patient. A positive change in number of letters read indicates an improvement in visual acuity.
3 secondary outcomes
Mean Change From Baseline in Contrast Sensitivity (40 Centimeters) at Month 21
Time frame: Baseline (Day 0, pretreatment), Month 21
Mean Change From Baseline in Central Drusen Volume at Month 21
Time frame: Baseline (Day 0, pretreatment), Month 21
Mean Change From Baseline in Low Luminance Best Corrected Visual Acuity (LLBCVA) at Month 21
Time frame: Baseline (Day 0, pretreatment), Month 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41791029Jaffe GJ, Boyer D, Hu A, Warrow D, Xavier S, Gonzalez V, Lad E, Rosen RB, Do DV, Schneiderman T, Ho AC, Munk MR, Tedford SE, Croissant CL, Ruckert R, Lavin PT, Tedford CE. LONG-TERM EFFICACY AND SAFETY OF PHOTOBIOMODULATION IN DRY AGE-RELATED MACULAR DEGENERATION (LIGHTSITE III: 24-MONTH ANALYSIS). Retina. 2026 May 1;46(5):783-795. doi: 10.1097/IAE.0000000000004822.
- 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.
Director, Clinical Trial Management, Surgical study director
Alcon Research, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valeda Light Delivery System in people with Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 10 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?
The sponsor lists 6 inclusion and 25 exclusion criteria. 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: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Best Corrected Visual Acuity (Letters Read) at Month 21 (time frame: Baseline (Day 0, pretreatment), Month 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04065490, which also lists 1 linked publication.
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 8 Oct 2026.