A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
Trial Parameters
Brief 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.
Eligibility Criteria
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, u