A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD (retinaSEES-PoC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intermediate AMD
• Intervention / Treatment: Device: reSEES

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mario Romano, Prof.; Phone Number: +39 02 8224 2555; Email: mario.romano.md@gmail.com
• Study Contact Backup: Name: Maria Belotti, MD; Phone Number: +39 02 8224 2555; Email: maria.belotti@gavazzeni.it

Study Locations

• Italy
  • Bergamo, Italy, 24128
    • Recruiting
    • Humanitas Castelli
    • Contact: Prof. Mario Romano; Phone Number: +39 02 8224 2555; Email: mario.romano.md@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Therapy - Treated Eye; Enrolled eye which will receive the light combined treatment.	Device: 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.
No Intervention: Intra-patient Control Eye; Contralateral eye used as control to relatively evaluate safety profile and performance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in visual acuity	Improvement in BCVA	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)	Rate of progression to advanced AMD by GA area measure	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)	Rate of progression of drusen area	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hyper-Iso-Hypo autofluorescence (FAF - Qualitative Signal Evolution)	Assess the development of the Hyper-Iso-Hypo autofluorescence signal at the perimeter of the GA lesion	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)	Development of the choriocapillaris network	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)	Assess visual functions with contrast sensitivity standard tests	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)
Microperimetry	Assessing retinal sensitivity in correspondence of morphological alteration	From Screening (T0 - 14 days), and on every second Follow-up Visits (T0 + 18 weeks, T0 + 52 weeks)
Perceived vision and mood	Assessment of perceived vision and mood using visual function questionnaire VFQ-25	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)
Usability	Assessment of usability of reSEES through questionnaire following standard scoring system	At last Treatment Session (T0 + 17 days)

Collaborators and Investigators

• Sponsor: Oculox Technologies SA
• Collaborators: Latis S.r.l.
• Investigators: Principal Investigator: Mario Romano, Prof., Director Department of Ophthalmology and Operational Unit, Full professor - Humanitas Gavazzeni

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 24, 2024
• First Submitted That Met QC Criteria: August 13, 2024
• First Posted (Actual): August 16, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 13, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Retina; mitochondria; phototherapy; hyperthermia; laser; RPE; iAMD; retinal pigment epithelium; amd; subthreshold; photo biomodulation; choriocapillaris; Para inflammation; cco; chromophore
• Other Study ID Numbers: Oculox Technologies SA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No