Clinical trial NCT06557369: A Clinical Trial Evaluating the Safety and Efficacy of a New Light Combination Therapy Addressing Intermediate AMD
Official title: A Prospective Proof-of-Concept Clinical Investigation to Evaluate Safety and Effectiveness of reSEES in Patients With Intermediate Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intermediate AMD
Keywords: phototherapy
subthreshold
laser
Retina
amd
iAMD
photo biomodulation
hyperthermia
mitochondria
choriocapillaris
Para inflammation
cco
RPE
retinal pigment epithelium
chromophore
Lead sponsor: Oculox Technologies SA
Sponsor class: INDUSTRY
Collaborators: name: Latis S.r.l.
First posted: 2024-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Absence of autofluorescence (FAF) laser-light spot
timeFrame: 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)
measure: Absence of NIR-cSLO laser-light spot traces
timeFrame: 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)
measure: Treatment-Emergent Adverse Events (TEAE)
timeFrame: 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:
measure: Improvement in visual acuity
timeFrame: 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)
measure: Progression to advanced AMD (SD-OCT)
timeFrame: 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)
measure: Progression of drusen cross-section (SD-OCT)
timeFrame: 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:
measure: Hyper-Iso-Hypo autofluorescence (FAF - Qualitative Signal Evolution)
timeFrame: 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)
measure: Choriocapillaris network reaction (OCTA - Qualitative Signal Evolution)
timeFrame: From Screening (T0 - 14 days), and on all Follow-up Visits (T0 + 18 weeks, T0 + 24 weeks, T0 + 52 weeks)
measure: Contrast sensitivity function (Quantitative Pelli-Robson protocol)
timeFrame: 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)
measure: Microperimetry
timeFrame: From Screening (T0 - 14 days), and on every second Follow-up Visits (T0 + 18 weeks, T0 + 52 weeks)
measure: Perceived vision and mood
timeFrame: 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)
measure: Usability
timeFrame: At last Treatment Session (T0 + 17 days)
Locations:
city: Bergamo
country: Italy
facility: Humanitas Castelli
Study officials:
affiliation: Director Department of Ophthalmology and Operational Unit, Full professor - Humanitas Gavazzeni
name: Mario Romano, Prof.
role: PRINCIPAL_INVESTIGATOR
References: