Status:
RECRUITING
A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
Lead Sponsor:
Oculox Technologies SA
Collaborating Sponsors:
Latis S.r.l.
Conditions:
Intermediate AMD
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
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 co...
Detailed Description
\*Objectives\* 1. The primary objective is to evaluate the safety of the reSEES treatment. 2. The secondary objective is to evaluate the effect of the reSEES treatment on the progression of intermedi...
Eligibility Criteria
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
- 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
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06557369
Start Date
November 1 2024
End Date
December 1 2025
Last Update
November 15 2024
Active Locations (1)
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1
Humanitas Castelli
Bergamo, Italy, 24128