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

NCT06557369 | Recruiting

• 1 other identifier: Oculox Technologies SA
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intermediate AMD

Keywords

phototherapy; subthreshold; laser; Retina; amd; iAMD; photo biomodulation; hyperthermia; mitochondria; choriocapillaris; Para inflammation; cco; RPE; retinal pigment epithelium; chromophore

Outcome Measures

Primary Outcomes (3)

• Absence of autofluorescence (FAF) laser-light spot

  Assessment of autofluorescence laser-light spot

  From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

• Absence of NIR-cSLO laser-light spot traces

  Assessment of NIR-cSLO laser-light spot

  From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

• Treatment-Emergent Adverse Events (TEAE)

  Incidence, severity and time of AE

  From the first Treatment Session (T0), at each subsequent Treatment Sessions (T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

Secondary Outcomes (3)

• Improvement in visual acuity

  From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

• Progression to advanced AMD (SD-OCT)

  From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

• Progression of drusen cross-section (SD-OCT)

  From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

Other Outcomes (6)

• Hyper-Iso-Hypo autofluorescence (FAF - Qualitative Signal Evolution)

  From Screening (T0 - 14 days), at each Treatment Sessions (T0, T0 + 3 days, T0 + 7 days, T0 + 10 days, T0 + 14 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

• Choriocapillaris network reaction (OCTA - Qualitative Signal Evolution)

  From Screening (T0 - 14 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

• Contrast sensitivity function (Quantitative Pelli-Robson protocol)

  From Screening (T0 - 14 days), every second Treatment Sessions (T0 + 3 days, T0 + 10 days, T0 + 17 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)

Study Arms (2)

Combination Therapy - Treated Eye

EXPERIMENTAL

Enrolled eye which will receive the light combined treatment.

Device: reSEES

Intra-patient Control Eye

NO INTERVENTION

Contralateral eye used as control to relatively evaluate safety profile and performance

Interventions

reSEES DEVICE

The treatment consists of combining SMPL and PBM light therapies to exploit the full advantage of their action. The combination will result in an additive or synergetic effect. * Treatment sessions are scheduled for three weeks after enrolment (Loading-Phase). * Two visits per week are needed. * At the first visit of every treatment week, two treatment sessions will follow each other; PBM is applied at least 15' after SMPL (treatment pairs). * Only PBM will be administered during the second visit of every treatment week. Patients will receive: * 1x SMPL treatment at days 0, 7, and 14 (3 in total), * 1x PBM treatment at days 0, 3, 7, 10, 14, and 17 (6 in total) Nine treatments will be delivered within three weeks. The study will be concluded with three follow-up visits at 18, 24, and 54 weeks.

Combination Therapy - Treated Eye

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Oculox Technologies SA: lead
• Latis S.r.l.: collaborator

Study Sites (1)

Humanitas Castelli

Bergamo, 24128, Italy

RECRUITING

MeSH Terms

Conditions

Glycogen Storage Disease Type II; Hyperthermia; Myopathy, Central Core

Condition Hierarchy (Ancestors)

Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Glycogen Storage Disease; Carbohydrate Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries; Myopathies, Structural, Congenital; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases

Study Officials

• Mario Romano, Prof.

  Director Department of Ophthalmology and Operational Unit, Full professor - Humanitas Gavazzeni

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Romano, Prof.

CONTACT

+39 02 8224 2555; mario.romano.md@gmail.com

Maria Belotti, MD

CONTACT

+39 02 8224 2555; maria.belotti@gavazzeni.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: August 16, 2024
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)