Purchase this article with an account.
David S Boyer; Intravitreal Nesvacumab+Aflibercept in Diabetic Macular Edema: The Phase 2 RUBY Trial. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3620.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To evaluate if a combination of intravitreal nesvacumab+aflibercept offered additional benefit over monotherapy with intravitreal aflibercept injection (IAI) in patients with diabetic macular edema (DME).
RUBY was a double-masked, active-controlled, multiple dose, multicenter, phase 2 study randomizing 302 patients with DME in a 1:2:3 ratio to receive either low dose combination (LD combo; nesvacumab+aflibercept 3 mg:2 mg), high dose combination (HD combo; nesvacumab+aflibercept 6 mg:2 mg) or IAI 2 mg. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) between week 12 and 36 as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
Over 88% of patients across all treatment groups completed 36 weeks of the study. Mean age at baseline was 62.1, 62.4, and 59.5 years in the LD combo, HD combo, and IAI groups, respectively. Across all treatment groups, 43% to 50% of patients were female. Mean baseline BCVA was 57.7, 60.6, and 58.7 letters in the LD combo, HD combo, and IAI groups, respectively. The corresponding baseline central retinal thickness (CRT) was 484.2, 497.8, and 520.1 µm, respectively. Outcomes in the IAI group were consistent with findings in previous clinical studies. Combination of intravitreal nesvacumab+aflibercept did not provide further visual benefit over IAI monotherapy. Patients treated with HD combo had significantly more reduction in CRT compared to patients treated with IAI at week 12 (least-square mean CRT change from baseline of -191.6 vs -163.8 µm, respectively; P = 0.0183). Significantly higher proportions of patients treated with HD combo had complete resolution of fluid at the foveal center at week 12 compared with patients treated with IAI (66.3% vs 53.7%, respectively; P = 0.0489). Proportion of patients with ≥2-step improvement in the Diabetic Retinopathy Severity Scale score from baseline at week 12 was 21.3% and 15.2% with HD combo and IAI, respectively. There were no new safety signals in these studies.
The results from the phase 2 RUBY study demonstrated anatomic benefits primarily with HD combo but similar visual results with both LD combo and HD combo compared to monotherapy with IAI in treatment of patients with DME.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
This PDF is available to Subscribers Only