September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Efficacy of ranibizumab therapy in eyes with neovascular AMD and pigment epithelial detachment (PED): a HARBOR subanalysis study
Author Affiliations & Notes
  • David Sarraf
    Department of Ophthalmology, Stein Eye Institute, UCLA, Los Angeles, California, United States
    Greater Los Angeles VA Healthcare Center, Los Angeles, California, United States
  • Lauren Hill
    Genentech, Inc., South San Francisco, California, United States
  • Na Lu
    Genentech, Inc., South San Francisco, California, United States
  • Shamika Gune
    Genentech, Inc., South San Francisco, California, United States
  • Lisa Tuomi
    Genentech, Inc., South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   David Sarraf, Genentech, Inc. (C), Regeneron (F); Lauren Hill, Genentech, Inc. (E); Na Lu, Genentech, Inc. (E); Shamika Gune, Genentech, Inc. (E); Lisa Tuomi, Genentech, Inc. (E)
  • Footnotes
    Support  Genentech, Inc., South San Francisco, CA, provided support for the study and participated in the study design; conducting the study; and data collection, management, and interpretation
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      David Sarraf, Lauren Hill, Na Lu, Shamika Gune, Lisa Tuomi; Efficacy of ranibizumab therapy in eyes with neovascular AMD and pigment epithelial detachment (PED): a HARBOR subanalysis study. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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

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Abstract

Purpose : To evaluate the anatomic and visual acuity (VA) outcomes, and the optimal treatment of eyes with neovascular AMD with PED including those that developed retinal pigment epithelial (RPE) tears during treatment based on data from the HARBOR study.

Methods : In the HARBOR study, 1097 study eyes were randomized to receive 3 consecutive monthly doses of intravitreal ranibizumab (RBZ) 0.5 mg or 2.0 mg. Eyes then either continued to receive monthly therapy or were treated PRN based on VA and strict SD-OCT criteria. In eyes with PED at baseline (BL), VA and anatomic outcomes were evaluated over 24 months. VA outcomes included change in best-corrected VA (BCVA) from BL. Anatomic outcomes included complete resolution of PED, reduction in PED height, development of macular atrophy (MA), and development and progression of RPE tear.

Results : 598 eyes presented with PEDs at BL with a height ranging from ~35-1400 µm. Eyes randomized to RBZ 0.5 mg and 2.0 mg PRN required 14.0 and 11.6 injections over 24 months, respectively. Mean change in BCVA from BL at 24 months was +9.0 letters in eyes randomized to RBZ 0.5 mg monthly; +8.4 letters to RBZ 0.5 mg PRN; +7.1 letters to RBZ 2.0 mg monthly and +7.2 letters to RBZ 2.0 mg PRN. PED resolved most often in eyes randomized to RBZ 2.0 mg monthly (70.5%) compared with RBZ 0.5 mg monthly (53.2%), RBZ 0.5 mg PRN (44.5%), and RBZ 2.0 mg PRN (57.3%). Eyes with resolution of PED had a significantly higher rate of MA at month 24 than eyes with PED present (44% vs 17%, P<.0001). Twenty-eight treated eyes with PED at BL developed a new RPE tear during the study. Of these, 21 RPE tears were in eyes with the largest PEDs (≥352 µm) at BL. Of RBZ-treated eyes with a new RPE tear by month 12 and 24 the mean change in BCVA (LOCF) from BL was +0.6 letters (n=25) and 0 letters (n=28), respectively.

Conclusions : In the >50% of patients with PED at baseline, an average +8-9 letters was gained from BL at 24 months with 0.5 mg ranibizumab therapy whether PRN or monthly in the HARBOR study. While greater PED resolution was seen with the higher RBZ dose, PED resolution was associated with a higher rate of MA and no additional vision benefit. On average, patients experiencing RPE tears during the study avoided vision loss with continued RBZ therapy.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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