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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorOculox Technologies SA

About this trial

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 criteria

Qualifiers

Male and female patients ≥ 50 years of age

Intermediate AMD, Grade AREDS 3

Both eyes eligible for the study Patients willing to enrol in a clinical study must sign a written informed consent form, cooperate with protocols, and comply with follow-up.

Dietary supplements and life-style habits must remain unchanged, as far as possible, for the duration of investigation participation.

Disqualifiers

Myopia > 8D

Maximum pupillary aperture ᴓ4mm with medical dilation

Anticipation of ocular surgery during the study

Clinically significative cataract

Trial design

Treatments tested in this trial

  • reSEES

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oculox Technologies SA

Lead sponsor

Latis S.r.l.

Collaborator