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

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 30, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Intermediate AMD
Interventions
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."

Trial Locations (1)

24128

RECRUITING

Humanitas Castelli, Bergamo

Sponsors
All Listed Sponsors
collaborator

Latis S.r.l.

INDUSTRY

lead

Oculox Technologies SA

INDUSTRY