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| Name | Class |
|---|---|
| Latis S.r.l. | INDUSTRY |
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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.
*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.
*Other objectives*
*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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination Therapy - Treated Eye | Experimental | Enrolled 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| reSEES | Device | 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.
Patients will receive:
Nine treatments will be delivered within three weeks. The study will be concluded with three follow-up visits at 18, 24, and 54 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of autofluorescence (FAF) laser-light spot | Assessment of autofluorescence laser-light spot | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in visual acuity | Improvement in BCVA | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Hyper-Iso-Hypo autofluorescence (FAF - Qualitative Signal Evolution) | Assess the development of the Hyper-Iso-Hypo autofluorescence signal at the perimeter of the GA lesion | 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mario Romano, Prof. | Contact | +39 02 8224 2555 | mario.romano.md@gmail.com | |
| Maria Belotti, MD | Contact | +39 02 8224 2555 | maria.belotti@gavazzeni.it |
| Name | Affiliation | Role |
|---|---|---|
| Mario Romano, Prof. | Director Department of Ophthalmology and Operational Unit, Full professor - Humanitas Gavazzeni | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanitas Castelli | Recruiting | Bergamo | 24128 | Italy |
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| ID | Term |
|---|---|
| D006009 | Glycogen Storage Disease Type II |
| D000084462 | Hyperthermia |
| D020512 | Myopathy, Central Core |
| ID | Term |
|---|---|
| D020140 | Lysosomal Storage Diseases, Nervous System |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
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|
Rate of progression to advanced AMD by GA area measure |
| 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 | 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) |
| Choriocapillaris network reaction (OCTA - Qualitative Signal Evolution) | Development of the choriocapillaris network | From Screening (T0 - 14 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks) |
| Contrast sensitivity function (Quantitative Pelli-Robson protocol) | Assess visual functions with contrast sensitivity standard tests | 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) |
| Microperimetry | Assessing retinal sensitivity in correspondence of morphological alteration | From Screening (T0 - 14 days), and on every second Follow-up Visits (T0 + 18 weeks, T0 + 52 weeks) |
| Perceived vision and mood | Assessment of perceived vision and mood using visual function questionnaire VFQ-25 | 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) |
| Usability | Assessment of usability of reSEES through questionnaire following standard scoring system | At last Treatment Session (T0 + 17 days) |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006008 | Glycogen Storage Disease |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D016464 | Lysosomal Storage Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
| D020914 | Myopathies, Structural, Congenital |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |