July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
Anti-VEGF/anti-angiopoietin-2 bispecific antibody RG7716 in diabetic macular edema: complete 36-week results from the phase 2, multicenter, randomized, active treatment-controlled BOULEVARD clinical trial
Author Affiliations & Notes
  • Sunil S Patel
    West Texas Retina Consultants, Abilene, Texas, United States
  • Jayashree Sahni
    Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland
  • Shamil Sadikhov
    Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland
  • Meike Pauly-Evers
    Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland
  • Piotr Szczesny
    Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland
  • Robert Weikert
    Roche Pharma Research and Early Development, Roche Innovation Center, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Sunil Patel, Alcon (F), Allergan (C), Allergan (F), Clearside Biomedical (F), Daiichi (F), Genentech, Inc. (C), Genentech, Inc. (F), Ophthotech (F), Regeneron (F); Jayashree Sahni, Roche Pharma Research and Early Development (E), Roche Pharma Research and Early Development (I); Shamil Sadikhov, Roche Pharma Research and Early Development (E), Roche Pharma Research and Early Development (I); Meike Pauly-Evers, Roche Pharma Research and Early Development (E), Roche Pharma Research and Early Development (I); Piotr Szczesny, Roche Pharma Research and Early Development (E), Roche Pharma Research and Early Development (I); Robert Weikert, Roche Pharma Research and Early Development (E), Roche Pharma Research and Early Development (I)
  • Footnotes
    Support  Hoffmann-La Roche Ltd, Basel, Switzerland, provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation.
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 1959. doi:
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      Sunil S Patel, Jayashree Sahni, Shamil Sadikhov, Meike Pauly-Evers, Piotr Szczesny, Robert Weikert; Anti-VEGF/anti-angiopoietin-2 bispecific antibody RG7716 in diabetic macular edema: complete 36-week results from the phase 2, multicenter, randomized, active treatment-controlled BOULEVARD clinical trial. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1959.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : RG7716 is a novel bispecific, monoclonal antibody that simultaneously binds and inactivates vascular endothelial growth factor A (VEGF-A) and angiopoietin-2. The phase 2 BOULEVARD study assessed the efficacy and safety of RG7716 compared with ranibizumab (RBZ) in treatment-naïve and previously treated patients (pts) with diabetic macular edema (DME). Here, we present for the first time the primary and secondary clinical outcomes from the phase 2 BOULEVARD study.

Methods : BOULEVARD (NCT02699450) is an ongoing prospective, randomized, comparator-controlled, double-masked, multi-center, multi-dose, 3-arm, phase 2 study. The trial enrolled anti-VEGF-treatment naïve pts and pts previously treated with anti-VEGF, aged ≥ 18 years, who had center-involving DME on spectral domain optical coherence tomography (SD-OCT). Inclusion criteria included best-corrected visual acuity (BCVA) between 73 and 24 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (approximate Snellen equivalent 20/40 to 20/320) and central subfield thickness (CST) ≥ 325 μm with Spectralis (Heidelberg). Eligible participants were randomized 1:1:1 to receive intravitreal RG7716 6.0 mg, RG7716 1.5 mg, or RBZ 0.3 mg. All pts were dosed monthly (28 days +/– 7 days) for 20 weeks. Subsequently, there was an observation period of up to 16 weeks for a total study length of 36 weeks. During the observation period, pts were evaluated at monthly intervals and exited the study if pre-specified re-treatment criteria were met for dosing with RBZ. The pre-specified primary outcome measure was mean change in BCVA (ETDRS letters) from baseline to week 24 in treatment-naïve pts.

Results : The study is ongoing at the time of abstract submission and by the time of presentation at the ARVO annual meeting, complete week 36 data will be available for all pts. Demographics, baseline characteristics, safety, visual and anatomic outcomes, and time to re-treatment data will be presented for all pts.

Conclusions : Safety and efficacy outcomes through week 36, including visual and anatomic measures, from the phase 2 BOULEVARD study comparing RBZ anti-VEGF monotherapy to dual VEGF/Ang-2 inhibition with the bispecific RG7716 antibody will be presented during the congress.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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