Intermediate AMDretinaSEES-PoCNCT06557369
A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
A study testing reSEES in people with Intermediate AMD, run by Oculox Technologies SA at 1 site in Italy.
Trial summary
The proposed clinical investigation wants primary to validate the safety of the innovative light therapy approach and in second priority provide insight and confirmations on therapeutic effect. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Intermediate AMD
- What is being tested?
- reSEES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 and female patients ≥ 50 years of age
- Intermediate AMD, Grade AREDS 3
- Both eyes eligible for the study Patients willing to enrol in a clinical study must sign a written informed consent form, cooperate with protocols, and comply with follow-up.
- Dietary supplements and life-style habits must remain unchanged, as far as possible, for the duration of investigation participation.
Who cannot join
- Myopia > 8D
- Maximum pupillary aperture ᴓ4mm with medical dilation
- Anticipation of ocular surgery during the study
- Clinically significative cataract
- Ocular surgery 6 months or less before study entry
- No previous retinal treatment, neither anti-VEGF (Anti-Vascular Endothelial Growth Factor ) therapy nor laser photocoagulation
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- Diabetic retinopathy
- Any other maculopathy and conditions as e.g. retinitis pigmentosa, DME (diabetic macular oedema), retinal lesions, retinal vessel occlusions etc
- Another obfuscating ocular disease including amblyopia, uncontrolled IOP (intraocular pressure), uncontrolled glaucoma or glaucomatous visual field loss, media opacity such as visually significant cataract, epiretinal membrane, vitreomacular traction, etc
- Concomitant systemic diseases and factors affecting the study, as per investigator's discretion
- Pregnant and lactating woman
- Concomitant participation in another interventional clinical study
- When it is expected that the patient will not be able to complete the trial due to mental health, age, or other personal issues.
- Photosensitivity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Castelli
Bergamo, 24128
Prof. Mario Romano, +39 02 8224 2555, mario.romano.md@gmail.com
About this study
Official title: A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration
The proposed clinical investigation wants primary to validate the safety of the innovative light therapy approach and in second priority provide insight and confirmations on therapeutic effect.
By combining two clinically standard laser-light treatment, both exhibiting a solid-safe profile: the photothermal and the photobiological techniques; the investigational device (reSEES) wants to explore a completely new therapeutic approach by synergically take advantage of the inherent and already observed clinical performances of the two independent techniques.
Read the detailed description
*Objectives*
- The primary objective is to evaluate the safety of the reSEES treatment.
- The secondary objective is to evaluate the effect of the reSEES treatment on the progression of intermediate AMD.
- Progression of intermediate AMD will be followed for one year,
- The contralateral eye will be used as a control to compare and observe relative and absolute progression and rate of progression.
*Other objectives*
- Evaluate the evolution of AMD-induced retinal morphological changes.
- Evaluate changes at the choriocapillaris vascular network and analyse/compare eventual transition to nAMD with natural history.
- Evaluate the effect of reSEES on retina functional parameters.
- Investigate the effect of reSEES on patients' perceived vision, mood, and general well-being.
- Evaluate the usability of the proposed laser console.
*Study Details*
30 patients are planned to be included in the study Enrolled patients will receive treatment on the left or the worst eye, and the fellow eye will be used as a control. Enrolled patients must have both eyes eligible for the study (rf. Inclusion Criteria)
*Measurements \& Procedures*
The measurements and procedures will be performed within 52 weeks.
- Total number of visits: 10
- Total number of treatments: 9 General health, medical history, and concomitant medication will be assessed and reported.
Ophthalmic examinations will be carried out at different time points: at screening, on Days 3, 10, and 17, and at the follow-up visits at 18, 24, and 52 weeks from T0 Adverse events and occurring changes in concomitant medication will also be collected for evaluation at every time point.
- Conditions
- Intermediate AMD
- Being tested
- reSEES
- Keywords
- phototherapy, subthreshold, laser, Retina, amd, iAMD, photo biomodulation, hyperthermia, mitochondria, choriocapillaris, Para inflammation, cco, RPE, retinal pigment epithelium, chromophore
- Medical subject headings
- Glycogen Storage Disease Type II, Hyperthermia, Myopathy, Central Core
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
reSEESDevice
The treatment consists of combining SMPL and PBM light therapies to exploit the full advantage of their action. The combination will result in an additive or synergetic effect.
- Treatment sessions are scheduled for three weeks after enrolment (Loading-Phase).
- Two visits per week are needed.
- At the first visit of every treatment week, two treatment sessions will follow each other; PBM is applied at least 15' after SMPL (treatment pairs).
- Only PBM will be administered during the second visit of every treatment week.
Patients will receive:
- 1x SMPL treatment at days 0, 7, and 14 (3 in total),
- 1x PBM treatment at days 0, 3, 7, 10, 14, and 17 (6 in total)
Nine treatments will be delivered within three weeks. The study will be concluded with three follow-up visits at 18, 24, and 54 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy - Treated Eye | Experimental | Enrolled eye which will receive the light combined treatment. Receives: Device: reSEES |
| Intra-patient Control Eye | No intervention | Contralateral eye used as control to relatively evaluate safety profile and performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absence of autofluorescence (FAF) laser-light spot
Assessment of autofluorescence laser-light spot
Measured: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Absence of NIR-cSLO laser-light spot traces
Assessment of NIR-cSLO laser-light spot
Measured: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Treatment-Emergent Adverse Events (TEAE)
Incidence, severity and time of AE
Measured: From the first Treatment Session (T0), at each subsequent Treatment Sessions (T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Secondary outcomes (3)
Improvement in visual acuity
Improvement in BCVA
Measured: From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Progression to advanced AMD (SD-OCT)
Rate of progression to advanced AMD by GA area measure
Measured: From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Progression of drusen cross-section (SD-OCT)
Rate of progression of drusen area
Measured: From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study startNov 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intermediate AMDStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oculox Technologies SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Latis S.r.l.
- Responsible party
- Sponsor
- Investigators
- Mario Romano, Prof., Principal investigator, Director Department of Ophthalmology and Operational Unit, Full professor - Humanitas Gavazzeni
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557369
- Sponsor's protocol ID
- Oculox Technologies SA
- Acronym
- retinaSEES-PoC
- Status last verified
- Nov 2024
- First submitted
- 24 May 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT06557369
- Acronym / sponsor ID
- retinaSEES-PoC / Oculox Technologies SA
- Conditions
- Intermediate AMD
- Keywords
- phototherapy, subthreshold, laser, Retina, amd, iAMD, photo biomodulation, hyperthermia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oculox Technologies SAIndustry (pharma, biotech, devices)
- Collaborators
- Latis S.r.l.
- Study start
- Nov 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Aug 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.
The proposed clinical investigation wants primary to validate the safety of the innovative light therapy approach and in second priority provide insight and confirmations on therapeutic effect.
By combining two clinically standard laser-light treatment, both exhibiting a solid-safe profile: the photothermal and the photobiological techniques; the investigational device (reSEES) wants to explore a completely new therapeutic approach by synergically take advantage of the inherent and already observed clinical performances of the two independent techniques.
Detailed description
*Objectives*
- The primary objective is to evaluate the safety of the reSEES treatment.
- The secondary objective is to evaluate the effect of the reSEES treatment on the progression of intermediate AMD.
- Progression of intermediate AMD will be followed for one year,
- The contralateral eye will be used as a control to compare and observe relative and absolute progression and rate of progression.
*Other objectives*
- Evaluate the evolution of AMD-induced retinal morphological changes.
- Evaluate changes at the choriocapillaris vascular network and analyse/compare eventual transition to nAMD with natural history.
- Evaluate the effect of reSEES on retina functional parameters.
- Investigate the effect of reSEES on patients' perceived vision, mood, and general well-being.
- Evaluate the usability of the proposed laser console.
*Study Details*
30 patients are planned to be included in the study Enrolled patients will receive treatment on the left or the worst eye, and the fellow eye will be used as a control. Enrolled patients must have both eyes eligible for the study (rf. Inclusion Criteria)
*Measurements \& Procedures*
The measurements and procedures will be performed within 52 weeks.
- Total number of visits: 10
- Total number of treatments: 9 General health, medical history, and concomitant medication will be assessed and reported.
Ophthalmic examinations will be carried out at different time points: at screening, on Days 3, 10, and 17, and at the follow-up visits at 18, 24, and 52 weeks from T0 Adverse events and occurring changes in concomitant medication will also be collected for evaluation at every time point.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy - Treated Eye | Experimental | Device: reSEESEnrolled eye which will receive the light combined treatment. |
| Intra-patient Control Eye | No intervention | –Contralateral eye used as control to relatively evaluate safety profile and performance |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients ≥ 50 years of age
- Intermediate AMD, Grade AREDS 3
- Both eyes eligible for the study Patients willing to enrol in a clinical study must sign a written informed consent form, cooperate with protocols, and comply with follow-up.
- Dietary supplements and life-style habits must remain unchanged, as far as possible, for the duration of investigation participation.
Key exclusion criteria (14 listed)
- Myopia > 8D
- Maximum pupillary aperture ᴓ4mm with medical dilation
- Anticipation of ocular surgery during the study
- Clinically significative cataract
- Ocular surgery 6 months or less before study entry
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 |
|---|---|---|
| reSEESThe treatment consists of combining SMPL and PBM light therapies to exploit the full advantage of their action. The combination will result in an additive or synergetic effect. * Treatment sessions are scheduled for three weeks after enrolment (Loading-Phase). * Two visits per week are needed. * At the first visit of every treatment week, two treatment sessions will follow each other; PBM is applied at least 15' after SMPL (treatment pairs). * Only PBM will be administered during the second visit of every treatment week. Patients will receive: * 1x SMPL treatment at days 0, 7, and 14 (3 in total), * 1x PBM treatment at days 0, 3, 7, 10, 14, and 17 (6 in total) Nine treatments will be delivered within three weeks. The study will be concluded with three follow-up visits at 18, 24, and 54 weeks. | Device | Combination Therapy - Treated Eye |
Primary outcome
Absence of autofluorescence (FAF) laser-light spot
Time frame: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Assessment of autofluorescence laser-light spot
Absence of NIR-cSLO laser-light spot traces
Time frame: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Assessment of NIR-cSLO laser-light spot
Treatment-Emergent Adverse Events (TEAE)
Time frame: From the first Treatment Session (T0), at each subsequent Treatment Sessions (T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Incidence, severity and time of AE
3 secondary outcomes
Improvement in visual acuity
Time frame: From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Progression to advanced AMD (SD-OCT)
Time frame: From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Progression of drusen cross-section (SD-OCT)
Time frame: From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 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.
Mario Romano, Prof. principal investigator
Director Department of Ophthalmology and Operational Unit, Full professor - Humanitas Gavazzeni
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing reSEES in people with Intermediate AMD, run by Oculox Technologies SA at 1 site in Italy.
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 14 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. 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 Italy. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Romano, Prof. (+39 02 8224 2555, mario.romano.md@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absence of autofluorescence (FAF) laser-light spot (time frame: From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)). The study lists 3 primary outcomes in all. 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 15 Nov 2024.