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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.
Full description
*Objectives*
The primary objective is to evaluate the safety of the reSEES treatment.
The secondary objective is to evaluate the effect of the reSEES treatment on the progression of intermediate AMD.
*Other objectives*
*Study Details*
30 patients are planned to be included in the study Enrolled patients will receive treatment on the left or the worst eye, and the fellow eye will be used as a control. Enrolled patients must have both eyes eligible for the study (rf. Inclusion Criteria)
*Measurements & Procedures*
The measurements and procedures will be performed within 52 weeks.
Ophthalmic examinations will be carried out at different time points: at screening, on Days 3, 10, and 17, and at the follow-up visits at 18, 24, and 52 weeks from T0 Adverse events and occurring changes in concomitant medication will also be collected for evaluation at every time point.
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Interventional model
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30 participants in 2 patient groups
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Central trial contact
Maria Belotti, MD; Mario Romano, Prof.
Data sourced from clinicaltrials.gov
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