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

*Objectives*

• The primary objective is to evaluate the safety of the reSEES treatment.
• 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.

Inclusion criteria

• 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.

Exclusion criteria

• Myopia > 8D
• Maximum pupillary aperture ᴓ4mm with medical dilation
• Anticipation of ocular surgery during the study
• Clinically significative cataract
• Ocular surgery 6 months or less before study entry
• No previous retinal treatment, neither anti-VEGF (Anti-Vascular Endothelial Growth Factor ) therapy nor laser photocoagulation
• Diabetic retinopathy
• Any other maculopathy and conditions as e.g. retinitis pigmentosa, DME (diabetic macular oedema), retinal lesions, retinal vessel occlusions etc
• Another obfuscating ocular disease including amblyopia, uncontrolled IOP (intraocular pressure), uncontrolled glaucoma or glaucomatous visual field loss, media opacity such as visually significant cataract, epiretinal membrane, vitreomacular traction, etc
• Concomitant systemic diseases and factors affecting the study, as per investigator's discretion
• Pregnant and lactating woman
• Concomitant participation in another interventional clinical study
• When it is expected that the patient will not be able to complete the trial due to mental health, age, or other personal issues.
• Photosensitivity