NCT06557369Recruiting
A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration
Source: ClinicalTrials.gov · Last updated 15 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 24 May 2024
- Start date
- Nov 2024
- Primary completion date
- Dec 2025
- Lead sponsor
- Oculox Technologies SA
- Diseases
- Macular degeneration
- NCT number
- NCT06557369
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Nov 2024 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Anticipation of ocular surgery during the study
- 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
- Concomitant systemic diseases and factors affecting the study, as per investigator's discretion
- Concomitant participation in another interventional clinical study
Other illness
- 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
Age
- When it is expected that the patient will not be able to complete the trial due to mental health, age, or other personal issues.
Other
- Myopia \> 8D
- Maximum pupillary aperture ᴓ4mm with medical dilation
- Clinically significative cataract
- Diabetic retinopathy
- Pregnant and lactating woman
- Photosensitivity
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Humanitas Castelli Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.