Tests a new light device for intermediate macular degeneration
Tests a new light therapy device, reSEES, in adults with intermediate age-related macular degeneration.
Plain-language title generated from the registry record
Registry title: A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
Key facts
- Where
- Bergamo, ItalySee the site
Where in Italy
- Humanitas CastelliBergamo, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oculox Technologies SA
- Trial code
- NCT06557369
- Record updated
- 15 November 2024
- Original description
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.Read full original descriptionShow less
A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration
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.
Inclusion: 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: Anticipation of ocular surgery during the study; 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; Concomitant systemic diseases and factors affecting the study, as per investigator's discretion; Concomitant participation in another interventional clinical study; 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; When it is expected that the patient will not be able to complete the trial due to mental health, age, or other personal issues; Myopia > 8D; Maximum pupillary aperture ᴓ4mm with medical dilation; Clinically significative cataract; Diabetic retinopathy; Pregnant and lactating woman; Photosensitivity.