About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Myopia > 8D

Maximum pupillary aperture ᴓ4mm with medical dilation

Anticipation of ocular surgery during the study

Clinically significative cataract

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Combination Therapy - Treated EyeExperimental treatment 1 intervention

Group B: Intra-patient Control EyeNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Absence of autofluorescence (FAF) laser-light spot

Assessment of autofluorescence laser-light spot

Time frame

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)

2

Absence of NIR-cSLO laser-light spot traces

Assessment of NIR-cSLO laser-light spot

Time frame

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)

3

Treatment-Emergent Adverse Events (TEAE)

Incidence, severity and time of AE

Time frame

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

1

Improvement in visual acuity

Improvement in BCVA

Time frame

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)

2

Progression to advanced AMD (SD-OCT)

Rate of progression to advanced AMD by GA area measure

Time frame

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)

3

Progression of drusen cross-section (SD-OCT)

Rate of progression of drusen area

Time frame

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

1

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

Time frame

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)

2

Choriocapillaris network reaction (OCTA - Qualitative Signal Evolution)

Development of the choriocapillaris network

Time frame

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

3

Contrast sensitivity function (Quantitative Pelli-Robson protocol)

Assess visual functions with contrast sensitivity standard tests

Time frame

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)

4

Microperimetry

Assessing retinal sensitivity in correspondence of morphological alteration

Time frame

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

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts