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

NCT ID: NCT06557369

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-12-31

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.

Detailed 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.

Conditions

Intermediate AMD

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Therapy - Treated Eye

Enrolled eye which will receive the light combined treatment.

Group Type: EXPERIMENTAL

reSEES

Intervention Type: 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.

Intra-patient Control Eye

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

reSEES

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Latis S.r.l.

INDUSTRY

Sponsor Role: collaborator

Oculox Technologies SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mario Romano, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Humanitas Castelli

Bergamo, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Mario Romano, Prof.

Role: CONTACT

mario.romano.md@gmail.com

+39 02 8224 2555

Maria Belotti, MD

Role: CONTACT

maria.belotti@gavazzeni.it

+39 02 8224 2555

Facility Contacts

Prof. Mario Romano

Role: primary

mario.romano.md@gmail.com

+39 02 8224 2555

Other Identifiers

Oculox Technologies SA

Identifier Type: -

Identifier Source: org_study_id