Evaluating a new light therapy for intermediate AMD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: mario.romano.md@gmail.com
• Phone: +39 02 8224 2555

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MacuTherm—photothermal therapy for intermediate AMD

  In people with intermediate AMD, this study tests a personalized photothermal treatment given with Navilas laser to see if it helps preserve photoreceptors and slow disease progression compared with a sham treatment.

  Recruiting at 10 sites OD-OS MacuTherm GmbH · Detmold and 9 other locations · NCT07607496

• Microcurrent therapy for advanced age-related macular degeneration

  This study is testing a new device that uses microcurrents to see if it can improve vision and eye health in people with advanced age-related macular degeneration.

  Recruiting at 11 sites i-Lumen Scientific AUS PTY LTD · Poway, California and 12 other locations · NCT06662162

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.