Actively Recruiting
A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
Led by Oculox Technologies SA · Updated on 2024-11-15
30
Participants Needed
1
Research Sites
56 weeks
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
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.
CONDITIONS
Official 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 procedures
- Ability to maintain stable dietary supplements and lifestyle habits during study participation
You will not qualify if you...
- Myopia greater than 8 diopters
- Maximum pupil dilation less than 4 mm
- Planned ocular surgery during the study
- Clinically significant cataract
- Ocular surgery within 6 months before study start
- Previous retinal treatments such as anti-VEGF therapy or laser photocoagulation
- Diabetic retinopathy
- Other macular diseases or retinal conditions like retinitis pigmentosa or diabetic macular edema
- Other eye diseases affecting vision including amblyopia, uncontrolled glaucoma, or media opacity
- Serious systemic diseases or conditions affecting study participation
- Pregnancy or breastfeeding
- Participation in another interventional clinical trial
- Expected inability to complete the study due to mental health, age, or personal issues
- Photosensitivity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Humanitas Castelli
Bergamo, Italy, 24128
Actively Recruiting
Research Team
M
Mario Romano, Prof.
CONTACT
M
Maria Belotti, MD
CONTACT
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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