RECRUITINGINTERVENTIONAL

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

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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.

Locations (1)

Humanitas Castelli

Bergamo, Italy