Actively Recruiting
A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration
Led by Oculox Technologies SA · Updated on 2024-11-15
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oculox Technologies SA
Lead Sponsor
L
Latis S.r.l.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating a new light therapy called reSEES for people with intermediate age-related macular degeneration (AMD). This study primarily aims to confirm the safety of this innovative approach, which combines two laser-light treatments with established safety records—the photothermal and photobiological techniques. The study also aims to observe how this combined therapy might affect the progression of intermediate AMD over one year, comparing treated eyes with the untreated fellow eyes as controls. Participants will receive the reSEES treatment on one eye, usually the left or the worse eye, while the other eye serves as a control. The treatment involves nine sessions over three weeks, combining selective micropulse laser (SMPL) and photobiomodulation (PBM) therapies. Treatment visits occur twice weekly, with paired sessions on the first visit of each week and PBM alone on the second. After treatment, patients will have follow-up visits at 18, 24, and 52 weeks to monitor effects and safety. During the 52-week study period, participants will attend a total of 10 visits for assessments including eye exams, visual acuity tests, and imaging scans such as fundus autofluorescence and near-infrared scanning laser ophthalmoscopy. Researchers will track safety by checking for laser-light spot absence and adverse events. They will also evaluate changes in retinal structure, function, vision, mood, and general well-being. Medical history and medication use will be recorded throughout to support comprehensive monitoring.
CONDITIONS
Brief Title
A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients 50 years of age or older
- Diagnosis of intermediate AMD, Grade AREDS 3
- Both eyes eligible for the study
- Willingness to sign informed consent and comply with study protocols and follow-up
- Ability to maintain dietary supplements and lifestyle habits unchanged during the study
You will not qualify if you...
- Myopia greater than 8 diopters
- Maximum pupillary aperture less than 4 mm with medical dilation
- Planned ocular surgery during the study
- Clinically significant cataract
- Ocular surgery within 6 months before study entry
- Previous retinal treatments such as anti-VEGF therapy or laser photocoagulation
- Presence of diabetic retinopathy
- Other maculopathies or retinal diseases like retinitis pigmentosa or diabetic macular oedema
- Obscuring ocular diseases including amblyopia, uncontrolled intraocular pressure, glaucoma, or media opacities
- Systemic diseases affecting the study as judged by the investigator
- Pregnancy or lactation
- Participation in another interventional clinical study
- Expected inability to complete the trial due to mental health, age, or personal reasons
- Photosensitivity conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive the reSEES light combination therapy on the treated eye over a 3-week loading phase involving multiple treatment sessions.
9 treatment sessions across multiple visits, with two visits per week
Duration - Approximately 34 weeks
Participants attend follow-up visits to monitor safety and effectiveness of the treatment and to observe disease progression for up to one year.
3 follow-up visits at 18, 24, and 52 weeks after treatment start
Trial Site Locations
Total: 1 location
1
Humanitas Castelli
Bergamo, Italy, 24128
Actively Recruiting
Research Team
M
Mario Romano, Prof.
M
Maria Belotti, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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