June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
The top 10 clinical pearls on treating pigment epithelial detachments due to neovascular age-related macular degeneration with ranibizumab in the HARBOR study
Author Affiliations & Notes
  • Arshad M Khanani
    Sierra Eye Associates, Reno, Nevada, United States
  • Lauren Hill
    Genentech, Inc., South San Francisco, California, United States
  • Lisa Tuomi
    Genentech, Inc., South San Francisco, California, United States
  • Footnotes
    Commercial Relationships   Arshad Khanani, Aerpio (F), Aerpio (C), Alcon (F), Allergan (F), Allergan (C), Allergan (R), Genentech, Inc. (F), Genentech, Inc. (C), Genentech, Inc. (R), Neurotech (F), Novartis Pharma A.G. (R), Ophthotech (F), Thrombogenics (F), Thrombogenics (C), Thrombogenics (R); Lauren Hill, 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 June 2017, Vol.58, 893. doi:
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      Arshad M Khanani, Lauren Hill, Lisa Tuomi; The top 10 clinical pearls on treating pigment epithelial detachments due to neovascular age-related macular degeneration with ranibizumab in the HARBOR study. Invest. Ophthalmol. Vis. Sci. 2017;58(8):893.

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

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Abstract

Purpose : To describe the key clinical findings relating to the optimal treatment of eyes with nAMD and pigment epithelial detachments (PED) based on data from HARBOR.

Methods : In HARBOR, 1097 study eyes were randomized to receive intravitreal ranibizumab (RBZ) 0.5 mg or 2.0 mg either monthly (M) or PRN based on VA and strict SD-OCT criteria after 3 M loading doses. In eyes with PED at baseline (BL), best-corrected VA (BCVA), anatomic outcomes, and development of retinal pigment epithelial (RPE) tears or macular atrophy (MA) were evaluated over 24 months. PEDs ranged from ~35-1400 µm at BL and size analyses used quartiles based on BL PED height.

Results : Quadrupling the dose of anti-VEGF to 2.0 mg demonstrated some additional anatomic response (PED resolution at 2 years: 0.5 mg, 53.2% [M], 44.5% [PRN]; 2.0 mg, 70.4% [M], 57.3% [PRN]), but on average vision gains were lower (mean change in BCVA from BL at 2 years: 0.5 mg, +9.0 letters [M], +8.4 [PRN]; 2.0 mg, +7.1 [M], 7.2 [PRN]). No additional vision was gained with complete resolution of PED (mean change in BCVA from BL at 2 years: resolution, +8.3 letters; PED present, +7.7). Vision improved regardless of RBZ regimen or PED size at BL (mean change in BCVA from BL to 2 years: small: +9.1 letters; medium: +9.0; large: +8.9; X-large: +4.7). Over 2 years, a similar mean number of injections was needed in RBZ 0.5 mg PRN arm regardless of BL PED size (small: 12.2; medium: 13.6; large: 14.0; X-large: 15.6). Only 5% of eyes with PED at BL developed a new on-study RPE tear with the majority (79%) occurring by month 3. 75% of on-study RPE tears occurred in eyes with X-large PED at BL. On average, RBZ-treated eyes with a new on-study non-foveal only RPE tear gained vision during the 24-month study (eyes with non-foveal only tear, +3.5 letters [n=20], eyes with foveal-involving, −24.5 [n=4]). Complete resolution of PED was associated with a higher rate of MA at month 24 than if PED was still present (44% vs 17%, respectively; P<.0001). Eyes with PED present at month 24 that did not develop MA had higher mean BL PED height than eyes with PED resolved that did develop MA (338 µm vs 263 µm; P=.0007).

Conclusions : Ranibizumab 0.5 mg monthly or PRN was safe and effective in eyes with nAMD and PED. While more PED resolution was seen with a higher ranibizumab dose, there was no additional vision benefit.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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