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

Last updated: November 13, 2024
Sponsor: Oculox Technologies SA
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

reSEES

Clinical Study ID

NCT06557369
Oculox Technologies SA
  • Ages > 50
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 mustsign a written informed consent form, cooperate with protocols, and comply withfollow-up.

  • Dietary supplements and life-style habits must remain unchanged, as far as possible,for the duration of investigation participation.

Exclusion

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 GrowthFactor ) therapy nor laser photocoagulation

  • Diabetic retinopathy

  • Any other maculopathy and conditions as e.g. retinitis pigmentosa, DME (diabeticmacular 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'sdiscretion

  • 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 tomental health, age, or other personal issues.

  • Photosensitivity

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: reSEES
Phase:
Study Start date:
November 01, 2024
Estimated Completion Date:
December 31, 2025

Study 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 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.

Connect with a study center

  • Humanitas Castelli

    Bergamo, 24128
    Italy

    Active - Recruiting

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