A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
Recruiting now · Not applicable
Conditions studied: Intermediate AMD
In brief
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.
Key facts
- Study ID
- NCT06557369
- Run by
- Oculox Technologies SA
- People needed
- 30
- Starts
- 2024-11-01
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2024-11-15
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Humanitas Castelli — Bergamo, Italy (enrolling)
Full record on ClinicalTrials.gov
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