ClinicalTrials.gov record NCT06557369

A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

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

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age50 years old and older
SexAll
LocationItaly
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study tests a new device (reSEES) that combines two light therapies in people with intermediate age-related macular degeneration, primarily to evaluate safety and secondarily to observe effects on disease progression. About 30 patients will get treatment in one eye while the other eye is used as a control. Treatment involves nine light sessions over three weeks and follow-up visits over about one year. The study is non-randomized and unmasked.

What it is studying. The study's primary test is whether the reSEES combined light treatment is safe in treated eyes. Secondarily it will look for effects on progression of intermediate AMD (using imaging and vision tests) and examine retinal and choriocapillaris changes, functional measures, patient-reported vision and well-being, and the device's usability.

What the researchers hope to learn. Primary scientific goal: evaluate the safety profile of the reSEES combined light therapy. Secondary goals: assess whether the treatment affects progression of intermediate AMD, measure changes in retinal structure and choriocapillaris circulation, track transition to advanced AMD, evaluate retinal function and patient-reported vision and mood, and assess the usability of the treatment console.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • reSEES

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

*Objectives*

  • The primary objective is to evaluate the safety of the reSEES treatment.
  • The secondary objective is to evaluate the effect of the reSEES treatment on the progression of intermediate AMD.
  • Progression of intermediate AMD will be followed for one year,
  • The contralateral eye will be used as a control to compare and observe relative and absolute progression and rate of progression.

*Other objectives*

  • Evaluate the evolution of AMD-induced retinal morphological changes.
  • Evaluate changes at the choriocapillaris vascular network and analyse/compare eventual transition to nAMD with natural history.
  • Evaluate the effect of reSEES on retina functional parameters.
  • Investigate the effect of reSEES on patients' perceived vision, mood, and general well-being.
  • Evaluate the usability of the proposed laser console.

*Study Details* 30 patients are planned to be included in the study Enrolled patients will receive treatment on the left or the worst eye, and the fellow eye will be used as a control. Enrolled patients must have both eyes eligible for the study (rf. Inclusion Criteria) *Measurements \& Procedures* The measurements and procedures will be performed within 52 weeks.

  • Total number of visits: 10
  • Total number of treatments: 9 General health, medical history, and concomitant medication will be assessed and reported.

Ophthalmic examinations will be carried out at different time points: at screening, on Days 3, 10, and 17, and at the follow-up visits at 18, 24, and 52 weeks from T0 Adverse events and occurring changes in concomitant medication will also be collected for evaluation at every time point.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participation involves about 10 study visits: nine light‑therapy treatments to one eye over a three‑week loading period (typically two visits per week, with some visits having two back‑to‑back sessions) and three follow‑up visits over about one year (the record lists visits at 18 weeks, 24 weeks and around 52 weeks). At visits you will have eye examinations and imaging (for example visual acuity checks and OCT/imaging assessments), general health and medication reviews, and questionnaires about vision, mood, and well‑being; adverse events will be recorded. The untreated fellow eye will serve as the control.

How the study is structured. Interventional (device) study where each participant receives the reSEES treatment in one eye and the fellow eye serves as an internal control. Non-randomized, no masking. Planned enrollment about 30 people. Participants receive nine treatment sessions over three weeks and are seen for a total of about 10 visits, with follow-up to roughly 52 weeks to monitor safety and disease measures.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Intermediate AMD. Does it apply to my diagnosis?
  • The listed sites are in Italy. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
November 2024 (estimated)
Primary completion
December 2025 (estimated)
Study completion
December 2025 (estimated)
Target enrollment
30 participants (estimated)
Last updated on registry
Nov 15, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Oculox Technologies SA
Collaborators
  • Latis S.r.l.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
primary objective
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
secondary objective
An additional result the study measures alongside the primary outcome, for example quality of life or a laboratory value.
natural history
A study that follows how a condition changes over time without assigning an experimental treatment. It may involve study visits and tests, and is often used to plan future trials.
concomitant medication
Other medicines a participant takes during the study. Some must be reported; some are restricted.
at screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Adverse events
Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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