Age Related Macular DegenerationLIGHTSITE1NCT02725762
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration
A study testing LT-300 Active (PBM) in people with Age Related Macular Degeneration, run by LumiThera, Inc. at 1 site in Canada.
Trial summary
The purpose of this research study is to determine if photobiomodulation is an effective treatment of Dry Age-Related Macular Degeneration (AMD) and vision loss associated with the disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- LT-300 Active (PBM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- Patients of both gender
- Patients must have dry macular degeneration in the study eye
- Best corrected visual acuity between 20/40 and 20/200
- Patients must be competent to sign and have signed a consent form before study entry
Who cannot join
- Visually significant cataracts.
- Presence of a visually significant posterior capsule if prior cataract surgery has been performed.
- Any visually significant disease process in any ocular structure that would affect vision unrelated to macular degeneration.
- A patient can be enrolled if only one of their eyes meets the criteria. The other eye may be treated but not included in the study; for example advanced geographic atrophy.
- Patients with severe clinically significant disease or unstable medical disorders including cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, CNS or life threatening disease or current malignancy at the discretion of the investigators
- Patients who are non-ambulatory or bed ridden
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- Female patients who are pregnant or of childbearing potential as effects of PBM on the developing human fetus are unknown.
- Patients with a history of Epilepsy
- Patients with a history of alcohol, drug or substance abuse in the past 6 months
- Patients deemed uncooperative or non compliant with the requirements of the protocol.
- Patients who have received any investigational drug or treatment within 30 days prior to study entry.
- Patients who are not competent to understand and sign consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Single-Center Study to Assess the Safety and Efficacy of Photobiomodulation in Subjects With Dry Age-Related Macular Degeneration
The purpose of this research study is to determine if photobiomodulation is an effective treatment of Dry Age-Related Macular Degeneration (AMD) and vision loss associated with the disease.
Read the detailed description
The LumiThera LT 300® Light Delivery System is a stationary desktop instrument used to emit energy in the visible and near infrared spectrum. The LT-300® is designed for the ophthalmologist to use in the treatment of the eye with photobiomodulation (PBM), a process by which cellular mechanisms are induced by light. PBM is being utilized in many indications, such as wound healing, soft tissue injuries, joint pain, myofascial pain, nerve injuries, muscle fatigue for temporary improvement in blood flow and reduction in inflammation. The mechanism of PBM at the cellular level has been ascribed to the activation of mitochondrial respiratory chain components resulting in stabilization of metabolic function and initiation of a signaling cascade, which promotes cellular proliferation and cytoprotection. The LT-300® will provide a preset treatment of PBM to the subject's eye and retinal tissue through the open and closed eyelid.
Approximately 30 subjects meeting the eligibility requirements of the study will be randomly assigned in a 1:1 ratio to receive standard of care treatment for Dry AMD plus PBM treatment with the LT-300 system, or standard of care treatment for Dry AMD plus Sham treatment with the LT-300 system. Subjects randomized to each group will receive two 3-week treatment sessions (9 treatments per session) and follow-up visits extending to one year. The primary objective of the study is to evaluate the safety and efficacy of PBM with respect to visual and anatomical outcomes of subjects with Dry AMD.
- Conditions
- Age Related Macular Degeneration
- Being tested
- LT-300 Active (PBM), LT-300 Inactive (Sham)
- Keywords
- Dry AMD, Vision Loss, AMD
- Medical subject headings
- Macular Degeneration, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LT-300 Active (PBM)Device
LT-300 Inactive (Sham)Device
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation Treatment | Experimental | Treatment with Photobiomodulation to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months. Receives: Device: LT-300 Active (PBM) |
| Sham Treatment | Sham comparator | Sham treatment to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months. Receives: Device: LT-300 Inactive (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity changes from baseline to month 12.
Visual acuity will be measured using ETDRS VA letter scoring to test the difference between the sham and treatment subjects in mean change from Baseline to Month 12
Measured: Through study completion, an average of one year.
Secondary outcomes (2)
Contrast Sensitivity
Contrast Sensitivity will be measured using the FACT Contrast Sensitivity Chart to test the difference between the sham and treatment subjects in mean change from Baseline to Month 12
Measured: Through study completion, an average of one year.
Optical Coherence Tomography (OCT)
OCT will be measured using the Spectralis SD-OCT to compare changes in dry AMD pathology.
Measured: Through study completion, an average of one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiThera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Samuel Markowitz, MD, Principal investigator, Private PracticeRobert G Devenyi, MD, Principal investigator, Ophthalmologist in Chief and Director of Retinal Services, The Donald K. Johnson Eye Center, University Health Network; Professor of Ophthalmology, The University of Toronto; Vitreoretinal Surgery Lead, The Kensington Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725762
- Sponsor's protocol ID
- CSP001
- Other IDs
- 1R43EY025508-01
- Acronym
- LIGHTSITE1
- Status last verified
- Jul 2026
- First submitted
- 23 Mar 2016
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Randomized, Sham-Controlled, Parallel Group, Single-Center Study to Assess the Safety and Efficacy of Photobiomodulation in Subjects With Dry Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02725762
- Acronym / sponsor ID
- LIGHTSITE1 / CSP001
- Conditions
- Age Related Macular Degeneration
- Keywords
- Dry AMD, Vision Loss, AMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- LumiThera, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI)
- Study start
- Mar 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 1 Apr 2016 (estimated)
- 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.
The purpose of this research study is to determine if photobiomodulation is an effective treatment of Dry Age-Related Macular Degeneration (AMD) and vision loss associated with the disease.
Detailed description
The LumiThera LT 300® Light Delivery System is a stationary desktop instrument used to emit energy in the visible and near infrared spectrum. The LT-300® is designed for the ophthalmologist to use in the treatment of the eye with photobiomodulation (PBM), a process by which cellular mechanisms are induced by light. PBM is being utilized in many indications, such as wound healing, soft tissue injuries, joint pain, myofascial pain, nerve injuries, muscle fatigue for temporary improvement in blood flow and reduction in inflammation. The mechanism of PBM at the cellular level has been ascribed to the activation of mitochondrial respiratory chain components resulting in stabilization of metabolic function and initiation of a signaling cascade, which promotes cellular proliferation and cytoprotection. The LT-300® will provide a preset treatment of PBM to the subject's eye and retinal tissue through the open and closed eyelid.
Approximately 30 subjects meeting the eligibility requirements of the study will be randomly assigned in a 1:1 ratio to receive standard of care treatment for Dry AMD plus PBM treatment with the LT-300 system, or standard of care treatment for Dry AMD plus Sham treatment with the LT-300 system. Subjects randomized to each group will receive two 3-week treatment sessions (9 treatments per session) and follow-up visits extending to one year. The primary objective of the study is to evaluate the safety and efficacy of PBM with respect to visual and anatomical outcomes of subjects with Dry AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation Treatment | Experimental | Device: LT-300 Active (PBM)Treatment with Photobiomodulation to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months. |
| Sham Treatment | Sham comparator | Device: LT-300 Inactive (Sham)Sham treatment to the retina at specific wavelengths to the eye three times a week for three weeks, repeated at six months. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both gender
- Patients must have dry macular degeneration in the study eye
- Best corrected visual acuity between 20/40 and 20/200
- Patients must be competent to sign and have signed a consent form before study entry
Key exclusion criteria (12 listed)
- Visually significant cataracts.
- Presence of a visually significant posterior capsule if prior cataract surgery has been performed.
- Any visually significant disease process in any ocular structure that would affect vision unrelated to macular degeneration.
- A patient can be enrolled if only one of their eyes meets the criteria. The other eye may be treated but not included in the study; for example advanced geographic atrophy.
- Patients with severe clinically significant disease or unstable medical disorders including cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, CNS or life threatening disease or current malignancy at the discretion of the investigators
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 |
|---|---|---|
| LT-300 Active (PBM) | Device | Photobiomodulation Treatment |
| LT-300 Inactive (Sham) | Device | Sham Treatment |
Primary outcome
Visual Acuity changes from baseline to month 12.
Time frame: Through study completion, an average of one year.
Visual acuity will be measured using ETDRS VA letter scoring to test the difference between the sham and treatment subjects in mean change from Baseline to Month 12
2 secondary outcomes
Contrast Sensitivity
Time frame: Through study completion, an average of one year.
Optical Coherence Tomography (OCT)
Time frame: Through study completion, an average of one year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- LIGHTSITE I ResultsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Samuel Markowitz, MD principal investigator
Private Practice
Robert G Devenyi, MD principal investigator
Ophthalmologist in Chief and Director of Retinal Services, The Donald K. Johnson Eye Center, University Health Network; Professor of Ophthalmology, The University of Toronto; Vitreoretinal Surgery Lead, The Kensington Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LT-300 Active (PBM) in people with Age Related Macular Degeneration, run by LumiThera, Inc. at 1 site in Canada.
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 4 inclusion and 12 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Acuity changes from baseline to month 12. (time frame: Through study completion, an average of one year.). 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 13 Jul 2026.