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Tara A McCannel, Abdhish Bhavsar, Antonio Capone, Hakan Demirici, Ivana K Kim, Brian Marr, Cadmus Rich, Amy C Schefler, Carol L. Shields; Two year results of a phase 1b/2 open-label clinical trial of AU-011 for the treatment of small to medium choroidal melanoma. Invest. Ophthalmol. Vis. Sci. 2019;60(9):719.
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© ARVO (1962-2015); The Authors (2016-present)
To present interim results of a trial evaluating the safety and preliminary efficacy of a potential vision-sparing targeted therapy for patients with choroidal melanoma.
Patients with choroidal melanoma with an apical height between 1.5 - 3.4 mm and largest basal diameter of ≤ 16 mm received intravitreal administration of a viral-like particle bioconjugate (AU-011) at doses of 20 µg, 40 µg, or 80µg followed by light-activation with a 689 nm laser at a fluence of 50 J/cm2. Regimens consisting of single, and repeat injections followed by 1 or 2 laser applications were evaluated, as well as repeat cylces of treatment.
36 patients have been treated with up to 80 µg x 3 doses and followed for a mean duration of 54 Weeks (range 20-110 weeks). Local tumor control has been observed in the majority of subjects. Five subjects have received additional radiotherapy; 1 with protocol-defined disease progression and 4 at investigator discretion. Mild/moderate adverse events (AEs), including intraocular inflammation and increased IOP, were clinically manageable. There were no related serious or severe AEs. Tumor thickness, tumor diameter and BCVA results by visit will be presented.
This study has shown preliminary safety and efficacy of AU-011 and that vision change during the mean follow-up period of 54 weeks is rare and may offer an alternative to radiotherapy. Further randomized controlled studies will be initiated to confirm the safety and efficacy of AU-011.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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