June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Suprachoroidal Microinjection of Bevacizumab is Well Tolerated in Human Patients
Author Affiliations & Notes
  • Virgilio Morales-Canton
    The Asociación Para Evitar La Ceguera (APEC), Mexico City, Mexico
  • Jans Fromow-Guerra
    The Asociación Para Evitar La Ceguera (APEC), Mexico City, Mexico
  • Samantha Salinas Longoria
    The Asociación Para Evitar La Ceguera (APEC), Mexico City, Mexico
  • Rafael Romero Vera
    The Asociación Para Evitar La Ceguera (APEC), Mexico City, Mexico
  • Michelle Widmann
    Clearside Biomedical, Alpharetta, GA
  • Samirkumar Patel
    Clearside Biomedical, Alpharetta, GA
  • Benjamin Yerxa
    The Asociación Para Evitar La Ceguera (APEC), Mexico City, Mexico
  • Footnotes
    Commercial Relationships Virgilio Morales-Canton, Clearside Biomedical (F); Jans Fromow-Guerra, None; Samantha Salinas Longoria, None; Rafael Romero Vera, None; Michelle Widmann, Clearside Biomedical, Inc. (E); Samirkumar Patel, Clearside Biomedical (E), Clearside Biomedical (I), Clearside Biomedical (P); Benjamin Yerxa, Clearside Biomedical (I)
  • Footnotes
    Support None
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 3299. doi:
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      Virgilio Morales-Canton, Jans Fromow-Guerra, Samantha Salinas Longoria, Rafael Romero Vera, Michelle Widmann, Samirkumar Patel, Benjamin Yerxa; Suprachoroidal Microinjection of Bevacizumab is Well Tolerated in Human Patients. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3299.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose: To evaluate the safety and tolerability of a single microneedle injection of bevacizumab into the suprachoroidal space (SCS) using a Clearside Biomedical proprietary microneedle

Methods: Four adult patients with choroidal neovascularization (CNV), secondary to wet age-related macular degeneration (AMD), were enrolled in a phase 1, single-center, open-label study. Each patient provided informed consent and was screened for eligibility. Following application of topical anesthesia, the patient was administered a single unilateral injection of 100 µL bevacizumab (Avastin®) into the SCS using an 850 µm 33 gauge Clearside Biomedical microneedle. The microneedle was inserted into the sclera approximately 8-12 mm posterior to the limbus in the superior temporal quadrant. Treated patients remained in the clinic for 4 hours for observation and then returned multiple times for follow-up during a 2 month period. Major safety examinations included intraocular pressure (IOP), angiograms, biomicroscopy, indirect ophthalmoscopy, fundus photography, optical coherence tomography (OCT), visual acuity (VA), and assessment of pain

Results: Preliminary data shows that four patients were successfully dosed into the SCS which was confirmed via ophthalmoscope immediately following injection. A moderate level of pain was recorded for the administration. There were no unexpected or serious adverse events related to bevacizumab or method of administration on ophthalmic examinations. No negative effect on IOP was noted in any patient. No patients required rescue therapy or reinjection during the two months following treatment

Conclusions: Preliminary data suggests that the SCS can be successfully and safely dosed via the Clearside Biomedical proprietary microneedle using only topical anesthesia. These data show that 100 µL bevacizumab can be delivered into the SCS without unexpected or serious adverse events

Keywords: 452 choroid • 561 injection • 412 age-related macular degeneration  
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