A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD

Condition(s) studied

Investigational drug(s) / intervention(s)

reSEES: 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 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.

Eligibility

Primary outcome measure(s)

• Absence of autofluorescence (FAF) 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)
  Assessment of autofluorescence laser-light spot
• Absence of NIR-cSLO laser-light spot traces — 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) — 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

Trial sites (1)