NCT06557369

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

A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Oculox Technologies SA · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

\*Objectives\* 1. The primary objective is to evaluate the safety of the reSEES treatment. 2. 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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-08-16
• Last updated: 2024-11-15

Locations

1 site across 1 country: Italy