Adapting to Progress: Evolving nAMD Trials Amid Therapeutic Expansion

Adapting to Progress Evolving nAMD Trials Amid Therapeutic Expansion
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  • Overview

    Drs. Dilsher Dhoot and Arshad M. Khanani explain the key aspects of the recently released FDA guidelines for clinical trial design in neovascular age-related macular degeneration and how these changes will influence the interpretation of clinical trial data and the subsequent integration of these therapies into clinical practice.

    This activity is supported by an independent medical education grant from Ocular Therapeutix.

     

  • Learning Objectives

    Upon completion of this activity, the participant should be able to:

    • Review key changes to trial design considerations that could stem from the FDA’s draft guidance for investigational therapies for nAMD
    • Explain the rationale for recent changes to clinical trial designs in nAMD
    • Summarize investigational therapies for nAMD that are in late phase clinical development
    • Evaluate how trial design choices for investigational therapies impact the interpretation of trial data and subsequent clinical decision-making
  • Accreditation

     Provided by Evolve Medical Education 

    Evolve is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
    Evolve designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  • Participation Method

    In order to obtain credit, proceed through the program, complete the posttest, evaluation and submit for credit.

  • Faculty and Disclosures

    Dilsher Dhoot, MD

    Dilsher Dhoot, MD

    California Retina Consultants
    Retina Consultants of America
    Santa Barbara, CA

     

    Arshad M. Khanani, MD, MA, FASRS

    Arshad M. Khanani, MD, MA, FASRS

    Director of Clinical Research
    Sierra Eye Associates
    Clinical Associate Professor
    University of Nevada
    Reno School of Medicine
    Reno, NV

     

    DISCLOSURE POLICY
    It is the policy of Evolve that faculty and other individuals who are in the position to control the content of this activity disclose any real or apparent financial relationships relating to the topics of this educational activity. Evolve has full policies in place that will identify and mitigate all financial relationships prior to this educational activity.

    The following faculty/staff members have the following financial relationships with ineligible companies.

    Dilsher Dhoot, MD, has had a financial relationship or affiliation with the following ineligible companies in the form of Consultant: Alimera Sciences, Allegro Ophthalmics, Allergan, Annexon Biosciences, Apellis Pharmaceuticals, Bayer, BioCryst, EyePoint Pharmaceuticals, Genentech, Iveric Bio, Novartis, Ocular Therapeutix, Regeneron, Regenxbio, Roche, and Santen. Grant/Research Support: Apellis Pharmaceuticals, Genentech, Ocular Therapeutix, Regeneron, and Regenxbio. Speaker’s Bureau: Alimera Sciences, Apellis Pharmaceuticals, Genentech, and Regeneron. 

    Arshad M. Khanani, MD, MA, FASRS, has had a financial relationship or affiliation with the following ineligible companies in the form of Consultant: AbbVie, Adverum, Alcon, Amgen, Annexin, Annexon, Apellis Pharmaceuticals, Aviceda Therapeutics, Beacon Therapeutics, Boehringer Ingelheim, Clearside Biomedical, Complement Therapeutics, 4DMT, Exegenesis, EyePoint Pharmaceuticals, Frontera Therapeutics, Genentech, Gyroscope Therapeutics, i-Lumen Scientific, Iveric Bio, Janssen Pharmaceuticals, Kodiak Sciences, Kriya Therapeutics, Nanoscope, Novartis, Ocular Therapeutix, Oculis, Ocuphire, OcuTerra, Olive BioPharma, Opthea, Oxular, Oxurion, Perfuse, Ray Therapeutics, Recens Medical, Regeneron, Regenxbio, Revive, RevOpsis, Roche, Sanofi, Stealth BioTherapeutics, Théa Pharma, Unity Biotechnology, Vanotech, and Vial. Grant/Research Support: Aviceda, Adverum, Alexion, Annexon, Apellis Pharmaceuticals, Aviceda Therapeutics, 4DMT, EyePoint Pharmaceuticals, Exegenesis, Genentech, Gyroscope Therapeutics, Iveric Bio, Janssen, Kodiak Sciences, Neurotech, Ocular Therapeutix, Oxular, and Regenxbio. Speaker’s Bureau: AbbVie, Apellis Pharmaceuticals, and Genentech. Stock/Shareholder: Aviceda Therapeutics, Oculis, Opthea, PolyPhotonix, Recens Medical, Perfuse, RevOpsis, and Vial. Advisory Board: Oculis.

    The Evolve staff, planners, and peer reviewer have no financial relationships with ineligible companies.

  • Disclaimer

    OFF-LABEL STATEMENT
    This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The opinions expressed in the educational activity are those of the faculty. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

    DISCLAIMER
    The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of Evolve or Ocular Therapeutix.

    This activity is designed for educational purposes. Participants have a responsibility to utilize this information to enhance their professional development to improve patient outcomes. Conclusions drawn by the participants should be derived from careful consideration of all available scientific information. The participant should use his/her clinical judgment, knowledge, experience, and diagnostic decision-making before applying any information, whether provided here or by others, for any professional use.

  • System Requirements

    • Supported Browsers (2 most recent versions):
      • Google Chrome for Windows, Mac OS, iOS, and Android
      • Apple Safari for Mac OS and iOS
      • Mozilla Firefox for Windows, Mac OS, iOS, and Android
      • Microsoft Edge for Windows
    • Recommended Internet Speed: 5Mbps+

  • Publication Dates

    Release Date:

    Expiration Date:

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