{
  "abstract": "Background Dry age-related macular degeneration (dAMD) is the leading cause of irreversible vision loss in older adults, with no approved treatment to modify progression in early and intermediate stages. Photobiomodulation (PBM), which targets mitochondrial dysfunction and retinal inflammation, has shown promise in early studies. This study aims to evaluate the anatomical and functional efficacy of PBM in eyes with early and intermediate dAMD.Methods In this 12-month, multicentre, randomised double-masked controlled trial, 138 eyes from 78 patients with early or intermediate dAMD were included. The primary outcome was change in mean drusen volume (MDV) from baseline to 12 months. Secondary outcomes included change in best-corrected visual acuity (BCVA) and adverse events. Multilevel mixed-effects regression was used to analyse treatment-time interactions.Results MDV decreased significantly in the PBM group (–0.03±0.05 mm³) while increased in the sham group (+0.02 ± 0.04 mm³; p<0.001) at 12 months. The PBM group also showed a significant improvement in BCVA (+1.31 ± 6.7 letters) compared with a decline in the sham group (–2.62±7.1 letters), yielding a between-group difference of +3.75 letters (95% CI 1.16 to 6.34; p=0.0001). Female sex and higher Age-Related Eye Disease Study (AREDS) category were associated with MDV increase over time (p=0.030 and p=0.003; respectively), while older age was associated with MDV reduction (p=0.049). Four eyes in the sham group developed macular neovascularisation, compared with none in the PBM group (p=0.044), while one eye in the PBM group developed geographic atrophy (p=1.00). No cases of retinal phototoxicity were observed.Conclusion PBM significantly reduced drusen burden and improved visual function in early and intermediate dAMD over 12 months, with an excellent safety profile. These findings support PBM as a promising therapeutic option for patients with non-neovascular age-related macular degeneration, despite further studies with longer follow-up are needed to confirm the role of PBM in potentially slowing the natural course of the disease.",
  "authors": [
    {
      "affiliations": [
        "Villa dei fiori Srl, Acerra, Campania, Italy"
      ],
      "name": "Claudio Iovino"
    },
    {
      "affiliations": [
        "Department of Surgical Sciences, University of Turin, Torino, Italy",
        "Department of Ophthalmology, University Hospital City of Science and Health Turin, Turin, Piedmont, Italy"
      ],
      "name": "Enrico Borrelli"
    },
    {
      "affiliations": [
        "Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Rome, Lazio, Italy"
      ],
      "name": "Giulia Coco"
    },
    {
      "affiliations": [
        "Department of Translational Biomedicine Neuroscience, University of Bari Aldo Moro, Bari, Italy"
      ],
      "name": "Pasquale Viggiano"
    },
    {
      "affiliations": [
        "Department of Translational Biomedicine Neuroscience, University of Bari Aldo Moro, Bari, Italy"
      ],
      "name": "Francesco Boscia"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Koc University School of Medicine, Istanbul, İstanbul, Turkey"
      ],
      "name": "Murat Hasanreisoglu"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Koc University School of Medicine, Istanbul, İstanbul, Turkey"
      ],
      "name": "Cem Kesim"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Ankara University Faculty of Medicine, Ankara University, Ankara, Ankara, Turkey"
      ],
      "name": "Sibel Demirel"
    },
    {
      "affiliations": [
        "Department of Ophthalmology, Ankara University Faculty of Medicine, Ankara University, Ankara, Ankara, Turkey"
      ],
      "name": "Özge Yanık"
    },
    {
      "affiliations": [
        "Ophthalmology Unit, Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy"
      ],
      "name": "Andrea Lucisano"
    },
    {
      "affiliations": [
        "Ophthalmology Unit, Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy"
      ],
      "name": "Vincenzo Scorcia"
    },
    {
      "affiliations": [
        "Eye Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Liguria, Italy",
        "DINOGMI, Dipartimento Di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno‑Infantili, University of Genoa, Genoa, Liguria, Italy"
      ],
      "name": "Aldo Vagge"
    },
    {
      "affiliations": [
        "Eye Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Liguria, Italy",
        "DINOGMI, Dipartimento Di Neuroscienze, Riabilitazione, Oftalmologia, Genetica e Scienze Materno‑Infantili, University of Genoa, Genoa, Liguria, Italy"
      ],
      "name": "Massimo Nicolò"
    },
    {
      "affiliations": [
        "Coordinating Body, Agea, Rome, Italy"
      ],
      "name": "Stefania Proietti"
    },
    {
      "affiliations": [
        "Service d’Ophtalmologie, Ophtalmopole de Paris, AP-HP, Hopital Cochin, Paris, Île-de-France, France"
      ],
      "name": "Federico Bernabei"
    },
    {
      "affiliations": [
        "Service d’Ophtalmologie, Ophtalmopole de Paris, AP-HP, Hopital Cochin, Paris, Île-de-France, France"
      ],
      "name": "Pierre-Raphaël R Rothschild"
    },
    {
      "affiliations": [
        "Earlam and Christopher Optometrist and Contact Lens Specialists, Taunton, UK"
      ],
      "name": "Sarah Farrant"
    },
    {
      "affiliations": [
        "Department of Surgical Sciences, University of Turin, Torino, Italy",
        "Department of Ophthalmology, University Hospital City of Science and Health Turin, Turin, Piedmont, Italy"
      ],
      "name": "Federico Ricardi"
    },
    {
      "affiliations": [
        "Department of Translational Medicine, University of Ferrara, Ferrara, Italy",
        "Department of Ophthalmology, Ospedali Privati Forli Villa Igea, Forli, Emilia-Romagna, Italy"
      ],
      "name": "Marco Pellegrini"
    },
    {
      "affiliations": [
        "Department of Translational Medicine, University of Ferrara, Ferrara, Italy"
      ],
      "name": "Marco Mura"
    },
    {
      "affiliations": [
        "Department of Translational Medicine, University of Ferrara, Ferrara, Italy"
      ],
      "name": "Antonio Cartabellotta"
    },
    {
      "affiliations": [
        "Department of Surgical Sciences, Eye Clinic, University of Cagliari, Cagliari, Sardinia, Italy"
      ],
      "name": "Giuseppe Giannaccare"
    },
    {
      "affiliations": [
        "Department of Surgical Sciences, University of Turin, Torino, Italy",
        "Department of Ophthalmology, University Hospital City of Science and Health Turin, Turin, Piedmont, Italy"
      ],
      "name": "Michele Reibaldi"
    },
    {
      "affiliations": [
        "Ophthalmology Unit, Department of Medical and Surgical Sciences, Magna Graecia University of Catanzaro, Catanzaro, Italy"
      ],
      "name": "Adriano Carnevali"
    }
  ],
  "title": "12-month outcomes of photobiomodulation in dry age-related macular degeneration: a prospective multicentre randomised double-masked controlled clinical trial",
  "uid": "8c511168-f0d3-512a-9731-487f7e3444d4"
}