June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Additional visual and anatomic outcomes of intravitreal aflibercept injection 8 mg versus 2 mg: a post hoc analysis of the Phase 2 CANDELA study
Author Affiliations & Notes
  • Jordana Goren Fein
    Retina Group of Washington, Fairfax, Virginia, United States
  • Footnotes
    Commercial Relationships   Jordana Fein Regeneron Pharmaceuticals Inc, Bausch and Lomb, Genentech/Roche, Apellis, Code C (Consultant/Contractor)
  • Footnotes
    Support  This study was funded by Regeneron Pharmaceuticals, Inc (Tarrytown, New York). The sponsor participated in the design and conduct of the study, analysis of the data, and preparation of this abstract. Editorial support was provided by Stephanie Agbu, PhD, of Regeneron Pharmaceuticals, Inc, Tarrytown, NY, USA, and Rob Campbell, PhD, of Core Medica, London, UK, according to Good Publication Practice guidelines.
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 2180. doi:
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    • Get Citation

      Jordana Goren Fein; Additional visual and anatomic outcomes of intravitreal aflibercept injection 8 mg versus 2 mg: a post hoc analysis of the Phase 2 CANDELA study. Invest. Ophthalmol. Vis. Sci. 2023;64(8):2180.

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

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Abstract

Purpose : To examine the effect of intravitreal aflibercept injection 8 mg on visual and anatomic outcomes in patients with neovascular age-related macular degeneration (nAMD).

Methods : In CANDELA, treatment-naïve patients with nAMD were randomized to receive 3 monthly doses of either aflibercept 2 mg (n=53) or aflibercept 8 mg (n=53) followed by doses at Weeks 20 and 32. This post hoc analysis was conducted to assess the proportion of eyes without intraretinal fluid (IRF), subretinal fluid (SRF), or sub-retinal pigment epithelium (RPE) fluid in the central subfield at Weeks 16 and 44, proportion of eyes that achieved >239 µm reduction in central subfield thickness (CST), ≥15-letter gain, best-corrected visual acuity (BCVA) ≥20/40, and BCVA ≥20/20 at Week 44, and proportion of eyes with baseline BCVA <20/40 that achieved ≥10- and ≥15-letter gains at Week 44.

Results : For eyes receiving aflibercept 8 mg versus those receiving 2 mg, the proportion of eyes without IRF, SRF, or sub-RPE fluid in the central subfield was 38% versus 19% at Week 16, respectively (nominal P=0.031), and 25% versus 11% at Week 44 (nominal P=0.076). At Week 44, a greater proportion of eyes had >239 µm reduction in CST with aflibercept 8 mg versus 2 mg (27% vs 20%). Additionally, at Week 44, a greater proportion of eyes in the aflibercept 8 mg versus 2 mg group gained ≥15-letters (33% vs 14%), achieved BCVA ≥20/40 (61% vs 49%) and achieved BCVA ≥20/20 (10% vs 2%). Conversely, a smaller proportion of eyes had vision loss/no BCVA change at Week 44 (20% vs 27% in the aflibercept 8 mg and 2 mg groups, respectively). Among eyes with baseline BCVA <20/40, a greater proportion in the aflibercept 8 mg versus 2 mg group gained ≥10 letters (65% vs 47%) and ≥15 letters (43% vs 18%) at Week 44.

Conclusions : Eyes treated with aflibercept 8 mg achieved improved visual and anatomical outcomes, suggesting potential therapeutic benefit compared with aflibercept 2 mg in patients with nAMD.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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