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To evaluate the safety, tolerability, and efficacy of efdamrofusp alfa in patients with neovascular age-related macular degeneration (nAMD).Randomized, open-label, multiple ascending-dose, phase 1b study.Patients aged 50 years or older with active choroid neovascularization (CNV) secondary to nAMD were screened from two hospitals in two provinces in China. The first nine patients were randomized 2:1 to intravitreally receive efdamrofusp alfa 2 mg at week 0, 4, 8 or aflibercept 2 mg at week 0, 4, 8, 16. After the dose limiting toxicity assessment, additional nine patients were randomized 2:1 to intravitreally receive efdamrofusp alfa 4 mg at week 0, 4, 8 or aflibercept 2 mg at week 0, 4, 8, 16. All patients were followed up till week 20. Primary outcomes were safety and tolerability of efdamrofusp alfa. Secondary outcomes included changes from baseline in best corrected visual acuity (BCVA), central subfield thickness (CST) as measured by spectral domain-optical coherence tomography (SD-OCT), and CNV area as measured by fluorescein angiography (FA).A total of 18 patients were enrolled and each six of them received efdamrofusp alfa 2 mg, efdamrofusp alfa 4 mg or aflibercept 2 mg, respectively. No dose-limiting toxicity reported and all patients completed the study. No ocular serious adverse event was reported. All ocular treatment-emergent adverse events were intravitreal injection related, mild or moderate in severity. At week 20, mean changes from baseline in BCVA were 5.64±3.56, 8.93±3.59 and 7.92±3.55 letters for patients receiving efdamrofusp alfa 2 mg, efdamrofusp alfa 4 mg and aflibercept 2 mg, respectively. Meanwhile, CST and CNV area reductions indicative of anatomic improvement were observed in the majority of the patients receiving both doses of efdamrofusp alfa and aflibercept.Intravitreal efdamrofusp alfa dosed up to 4 mg every 4 weeks was well tolerated in nAMD patients with similar vision acuity and anatomic improvements.ClinicalTrials.gov identifier NCT04370379. |
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