A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
NCT Number: NCT06557369
Acronym: retinaSEES-PoC
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Intermediate AMD
Interventions: DEVICE: reSEES
Sponsor: Oculox Technologies SA
Collaborators: Latis S.r.l.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2025-12-30

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.

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.

Primary Outcome Measures: 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)
Secondary Outcome Measures: 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), 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)
Other Outcome Measures: 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)|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)