Dry Age-related Macular DegenerationNCT03878420
Study of Photobiomodulation to Treat Dry Age-Related Macular Degeneration (LIGHTSITE II)
A study testing Valeda PBM treatment in people with Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 8 sites in 5 countries.
Trial summary
This LIGHTSITE II 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. Read more about this study
- Who is it for?
- Ages 50 to 120 years
- Conditions the study is for
- Dry Age-related Macular Degeneration
- What is being tested?
- Valeda PBM treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 14 Feb 2019to 22 Jan 2021
- 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 to 120 years
- 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
- Subjects with 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 is outside the letter score by up to two letters at Baseline, the subject may be entered in the study.
- Subjects with a diagnosis of dry AMD as defined by the presence of drusen (regular or reticular pseudodrusen) and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or Heidelberg FAF
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
- Subject is 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:
- 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 22Show fewer
- 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). 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)
- Has a 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 there is a history of light activated CNS disorders (e.g. epilepsy, migraine)
- Use of any photosensitizing agent (e.g. topicals, injectables) 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
- In the opinion of the Investigator, is unlikely to comply with the study protocol
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
Germany3 sites
Universitätsklinikum Freiburg- Klinik für Augenheilkunde
Freiburg im Breisgau, 79106
Klinik fur Ophthalmologie, Universitatsklinikum Schleswig-Holstein
Kiel
Universitaetsmedizin Mainz- Augenklinik
Mainz, 55131
United Kingdom2 sites
James Paget University
Great Yarmouth, NR31 6LA
Peterborough City Hospital
Peterborough, PE3 9GZ
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 II)
This LIGHTSITE II 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.
Read the detailed description
This 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. The target enrollment is 96 subjects in up to 10 centers in Europe, randomized at a 1:2 ratio into 2 groups: Sham Treatment (S-1) and PBM Treatment (T-2). Once 96 subjects have been enrolled in the study, if there are less than 144 eyes that qualify for the study, additional subjects will be enrolled until 144 eyes have been included in the study.
S-1 will receive 3 sham treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. T-2 will receive 3 PBM treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. Each treatment series will total 9 treatments. Neither the subject nor the study staff will know which treatment the subject has been assigned.
Subjects will receive standard visual outcome measurements including Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA, CSV-1000E contrast sensitivity (CS) and the Radner Reading Test prior to and following each treatment series as well as eye exams, fundus photographs, Heidelberg OCT and FAF imaging and optional Optos Ultra Wide Field (UWF) imaging of the retina at selected time intervals. Subjects will also complete the Visual Function Questionnaire 25 (VFQ-25) at selected time intervals.
- Conditions
- Dry Age-related Macular Degeneration
- Being tested
- Valeda PBM treatment, Valeda Sham treatment
- Keywords
- Dry AMD, Photobiomodulation, Visual Acuity, Contrast Sensitivity, Optical Coherence Tomography, Drusen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valeda PBM treatmentDevice
The Valeda Light Delivery System delivers 590, 660 and 850 nm wavelengths of light to the study eye. The Valeda Light Delivery System will treat through the open eyelid with the 590 nm and 850 nm wavelengths together. The 660 nm wavelength will be treated through the closed eyelid.
Valeda Sham treatmentDevice
The sham mode emits an approximate 100x reduction in the highest dose for the 660 nm wavelengths as compared to the treatment mode, producing a slightly duller light. The 850 nm (NIR) wavelength (which is not visible light) is not provided in the sham treatment.
| Study group | Role | What they receive |
|---|---|---|
| PBM Treatment | Experimental | The Valeda™ Light Delivery System will deliver 590, 660 and 850 nm wavelengths together. Receives: Device: Valeda PBM treatment |
| Sham Treatment | Sham comparator | The Valeda™ Light Delivery System will deliver non-effective treatment of the 590 and 660 nm wavelengths together. Receives: Device: Valeda Sham treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
The primary efficacy endpoint will be the change in BCVA from Baseline to Month 9 as assessed using the ETDRS BCVA chart.
Measured: Month 9
Secondary outcomes (4)
Best Corrected Visual Acuity
The first of the secondary analyses will test the difference between the sham-treated and PBM-treated subjects in mean change from baseline (pre-treatment) to Month 9 in BCVA.
Measured: Month 9
Contrast Sensitivity
The second of the secondary analyses will test the difference between the sham-treated and PBM-treated subjects in mean change from baseline (pre-treatment) to Month 9 in contrast sensitivity at 18 cycles/degree (CPD).
Measured: Month 9
Impact on Central Drusen Volume by OCT
The analyses will first examine change from the screening visit in central Drusen volume
Measured: Month 10
Impact on Central Drusen Thickness by OCT
The analyses will then examine change from the screening visit in central Drusen Thickness
Measured: Month 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start14 Feb 2019
- Primary completion22 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- LumiThera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878420
- Sponsor's protocol ID
- CSP003
- Status last verified
- Aug 2021
- First submitted
- 15 Mar 2019
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Burton B, Parodi MB, Jurgens I, Zanlonghi X, Hornan D, Roider J, Lorenz K, Munk MR, Croissant CL, Tedford SE, Walker M, Ruckert R, Tedford CE. LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration. Ophthalmol Ther. 2023 Apr;12(2):953-968. doi: 10.1007/s40123-022-00640-6. Epub 2023 Jan 2.
PubMed 36588113
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. 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 II)
- ClinicalTrials.gov ID
- NCT03878420
- Acronym / sponsor ID
- CSP003
- Conditions
- Dry Age-related Macular Degeneration
- Keywords
- Dry AMD, Photobiomodulation, Visual Acuity, Contrast Sensitivity, Optical Coherence Tomography, Drusen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- LumiThera, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 18 Mar 2019 (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 LIGHTSITE II 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.
Detailed description
This 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. The target enrollment is 96 subjects in up to 10 centers in Europe, randomized at a 1:2 ratio into 2 groups: Sham Treatment (S-1) and PBM Treatment (T-2). Once 96 subjects have been enrolled in the study, if there are less than 144 eyes that qualify for the study, additional subjects will be enrolled until 144 eyes have been included in the study.
S-1 will receive 3 sham treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. T-2 will receive 3 PBM treatments per week over 3 to 5 weeks starting at Baseline and starting again at Months 4 and 8. Each treatment series will total 9 treatments. Neither the subject nor the study staff will know which treatment the subject has been assigned.
Subjects will receive standard visual outcome measurements including Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA, CSV-1000E contrast sensitivity (CS) and the Radner Reading Test prior to and following each treatment series as well as eye exams, fundus photographs, Heidelberg OCT and FAF imaging and optional Optos Ultra Wide Field (UWF) imaging of the retina at selected time intervals. Subjects will also complete the Visual Function Questionnaire 25 (VFQ-25) at selected time intervals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Valeda Light Delivery System
| Arm | Type | Receives |
|---|---|---|
| PBM Treatment | Experimental | Device: Valeda PBM treatmentThe Valeda™ Light Delivery System will deliver 590, 660 and 850 nm wavelengths together. |
| Sham Treatment | Sham comparator | Device: Valeda Sham treatmentThe Valeda™ Light Delivery System will deliver non-effective treatment of the 590 and 660 nm wavelengths together. |
Who may qualify
- Ages
- 50 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 50 years of age at Screening visit
- Subjects with 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 is outside the letter score by up to two letters at Baseline, the subject may be entered in the study.
- Subjects with a diagnosis of dry AMD as defined by the presence of drusen (regular or reticular pseudodrusen) and/or geographic atrophy (GA) visible on two of the following: color fundus images, OCT and/or Heidelberg FAF
- Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
- Subject is informed of the nature of this study and has provided written informed consent in accordance with institutional, local and national regulatory guidelines
Key exclusion criteria (22 listed)
- Current or history of neovascular maculopathy that includes any of the following:
- 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). 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 PBM treatmentThe Valeda Light Delivery System delivers 590, 660 and 850 nm wavelengths of light to the study eye. The Valeda Light Delivery System will treat through the open eyelid with the 590 nm and 850 nm wavelengths together. The 660 nm wavelength will be treated through the closed eyelid. | Device | PBM Treatment |
| Valeda Sham treatmentThe sham mode emits an approximate 100x reduction in the highest dose for the 660 nm wavelengths as compared to the treatment mode, producing a slightly duller light. The 850 nm (NIR) wavelength (which is not visible light) is not provided in the sham treatment. | Device | Sham Treatment |
Primary outcome
Best Corrected Visual Acuity
Time frame: Month 9
The primary efficacy endpoint will be the change in BCVA from Baseline to Month 9 as assessed using the ETDRS BCVA chart.
4 secondary outcomes
Best Corrected Visual Acuity
Time frame: Month 9
Contrast Sensitivity
Time frame: Month 9
Impact on Central Drusen Volume by OCT
Time frame: Month 10
Impact on Central Drusen Thickness by OCT
Time frame: Month 10
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 2 Sep 2021.
- Derived from this study: PubMed 36588113Burton B, Parodi MB, Jurgens I, Zanlonghi X, Hornan D, Roider J, Lorenz K, Munk MR, Croissant CL, Tedford SE, Walker M, Ruckert R, Tedford CE. LIGHTSITE II Randomized Multicenter Trial: Evaluation of Multiwavelength Photobiomodulation in Non-exudative Age-Related Macular Degeneration. Ophthalmol Ther. 2023 Apr;12(2):953-968. doi: 10.1007/s40123-022-00640-6. Epub 2023 Jan 2.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valeda PBM treatment in people with Dry Age-related Macular Degeneration, run by LumiThera, Inc. at 8 sites in 5 countries.
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 5 inclusion and 22 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 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, United Kingdom, France, Italy, Spain. 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?
Best Corrected Visual Acuity (time frame: Month 9). 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 NCT03878420, 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 2 Sep 2021.