Evaluating a new light therapy for intermediate AMD

A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration

This study is testing a new light therapy for people with intermediate age-related macular degeneration to see if it is safe and helps improve their vision.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Oculox Technologies SA (industry)
• Locations: 1 site (Bergamo)
• Trial ID: NCT06557369 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to validate the safety and efficacy of a novel light combination therapy called reSEES for patients with intermediate age-related macular degeneration (AMD). The study will involve 30 participants who will receive treatment on one eye while the other eye serves as a control. The primary focus is on assessing the safety of the treatment, while secondary objectives include monitoring the progression of AMD and evaluating changes in retinal morphology and patient-reported outcomes over a year. Participants will undergo a series of ophthalmic examinations and treatments throughout the study period.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older diagnosed with intermediate AMD in both eyes.

Not a fit: Patients with significant ocular conditions, such as diabetic retinopathy or recent ocular surgeries, may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could slow the progression of intermediate AMD and improve patients' vision and quality of life.

How similar studies have performed: While this approach combines established techniques, the specific combination therapy is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Bergamo

• Humanitas Castelli — Bergamo, Italy (RECRUITING)

Study contacts

• Principal investigator: Mario Romano, Prof. — Director Department of Ophthalmology and Operational Unit, Full professor - Humanitas Gavazzeni
• Study coordinator: Mario Romano, Prof.

Conditions: Intermediate AMD, phototherapy, subthreshold, laser, Retina, amd, iAMD, photo biomodulation