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

RecruitingNAAges 50 Years - anyAllOculox Technologies SA
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male and female patients โ‰ฅ 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 แด“4mm 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
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What it tests

  • reSEES
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Where

1 site
Humanitas Castelli
Bergamo, Italy
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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