Background/aims: This study evaluated the short-term safety and feasibility of epiretinal strontium-90 brachytherapy delivered concomitantly with intravitreal bevacizumab for the treatment of subfoveal CNV due to AMD for 12 months. A 3-year follow-up is planned.
Methods: In this prospective, non-randomised, multicentre study, 34 treatment-naïve patients with predominantly classic, minimally classic and occult subfoveal CNV lesions received a single treatment with 24 Gy beta radiation (strontium-90) and two injections of the anti-VEGF antibody bevacizumab. Adverse events were observed. BCVA was measured using standard ETDRS vision charts.
Results: Twelve months after treatment, no radiation-associated adverse events were observed. In the intent-to-treat (ITT) population, 91% of patients lost <3 lines (15 ETDRS letters) of vision at 12 months, 68% improved or maintained their BCVA at 12 months, and 38% gained ⩾3 lines. The mean change in BCVA observed at month 12 was a gain of 8.9 letters.
Conclusion: The safety and efficacy of intraocular, epiretinal brachytherapy delivered concomitantly with anti-VEGF therapy for the treatment of subfoveal CNV secondary to AMD were promising in this small study population. Long-term safety will be assessed for 3 years. This regimen is being evaluated in a large, multicentre, phase III study.
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Competing interests: BWW and JN are employed by NeoVista, and have a proprietary interest in the investigational device.
Ethics approval: Ethics approval was provided by Centro Oftalmologico Ethics Committee, São Paulo, Brazil; Centro Brasileiro de Cirurgia de Oihos Ethics Committee, Goina, Brazil; and Universidad de Guadalajara Ethics Committee, Guadalajara, Jalisco, Mexico.
Patient consent: Obtained.