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About This Activity

Activity Description and Learning Objectives

In this activity, internationally recognized experts in ophthalmology discuss the latest data on the clinical management of nAMD, including the importance of regular monitoring, application of optimal dosing regimens for individual patients and role of novel drug delivery systems and agents.

This activity has been jointly provided by Oakstone and touchIME. Oakstone Publishing is accredited by the ACCME to provide continuing medical education to physicians.

After watching this activity, participants should be better able to:

  • Evaluate strategies for the management of retinal fluid in nAMD
  • Interpret results from clinical trials and real-world experience to inform on optimal dosing of anti-VEGF in nAMD
  • Recall factors that contribute to optimization of clinical management and reduction in treatment burden for patients with nAMD

Target Audience

This activity is designed to meet the educational needs of ophthalmologists and retinal disease specialists worldwide.

Disclosures

Oakstone Publishing has assessed conflict of interest with its faculty, authors, editors, and any individuals who were in a position to control the content of this CME activity. Any identified relevant conflicts of interest were resolved for fair balance and scientific objectivity of studies utilized in this activity. Oakstone Publishing’s planners, content reviewers, and editorial staff disclose no relevant commercial interests.

Prof. Pravin Dugel

Disclosures: Advisory board member: Acucela, Aerpio, Alcon Pharmaceutical, Alcon Surgical (RACII), Alimera Sciences, Abbott Medical Optics Incs, Annidis, ArticDX, ASRS Board, Avalanche, Bausch, Beyeonics, CDR-Life Inc., Clearside Biomedical, Digisight, DOSE Medical, Euretina Board, Gemini Pharmaceutical, Genentech, Graybug Vision, Lutronic, LUX BioScience, MacuSight, NeoVista, Neurotech, Novartis, Oculis, Omeros, Opthea, Ophthotech, Orbis International, Oxurion, Regenxbio, Reneuron, Retina World Congress, Roche, Santen, Inc, Shire Human Genetics, Stealth Biotherapeutics, Thrombogenics and TrueVision; Consultant for, Acucela, Aerie Pharmaceutical, Aerpio, Alcon Pharmaceutical, Alcon Surgical, Allergan, Alimera Sciences, Amgen, Annidis, ArticDX, Arctic Vision, AsclepiX Therapeutics Inc., Bausch & Lomb Pharma, BeyeOnics, BioBridge/Retinagenix, Boehringer Ingelheim, Chengdu Kanghong Biotechnology, Clearside Biomedical, Daiichi Sankyo, DigiSight, DOSE Medical, FoxKiser, Gemini Pharmaceutical, Genentech, Glaukos, Graybug Vision, Kodiak Sciences, Irenix, jCyte, Ionis, Lutronic, LUX BioScience, MacuSight, Merck, Nan Fung Group, NeoVista, Neurotech, Novartis, Oculis SA, Omeros, Opthea, Ophthotech, Optovue, ORA, PanOptica, Pentavision, Pieris Pharmaceutical, pSiveda/Eyepoint, RegenexBio, Reneuron. Roche, Santen, Inc., SciFluor Life Sciences, Shire Human Genetics, Spark Therapeutics, Stealth Biotherapeutics, Thrombogenics, TopCon and Zeiss Group; Minor stockholder with: Aerpio, Allegro, ArctixDx, Arctic Vision, Clearside Biomedical, Digisight/Verana, FoxKiser, Graybug, Irenix, Nan Fung Group, Oculis, Ophthotech, PanOptica, SciFluor and TrueVision. Employee and shareholder: IVERIC Bio.

Content Reviewer

Walter Murray Yarbrough, MD, FACP, has no financial interests/relationships or affiliations in relation to this activity.

Touch Medical Director

Kathy Day has no financial interests/relationships or affiliations in relation to this activity.

Requirements for Successful Completion

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Oakstone Publishing and touchIME. Oakstone Publishing is accredited by the ACCME to provide continuing medical education for physicians.

The European Union of Medical Specialists (UEMS) – European Accreditation Council for Continuing Medical Education (EACCME) has an agreement of mutual recognition of continuing medical education (CME) credit with the American Medical Association (AMA). European physicians interested in converting AMA PRA Category 1 Credit™ into European CME credit (ECMEC) should contact the UEMS (www.uems.eu)

Oakstone Publishing designates this enduring material for a maximum of 0.5 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

In order to receive credit for this activity, participants must review and complete the post-test and evaluation form. A score of 70% or higher is needed to obtain CME credit. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

Date of original release: July 22, 2020. Date credits expire: July 22, 2021.

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Q1. Which of the following statements best describe the relationship between retinal fluid and vision in nAMD?

  1. The presence of sub-retinal fluid prevents patients achieving good visual outcomes
  2. The presence of intra-retinal fluid can be tolerated without affecting visual outcomes
  3. There is no relationship between CRT/CST and visual outcomes
  4. Greater variability in CRT/CST is associated with vision loss and worse patient-reported outcomes

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Undertreatment of nAMD consistently results in sub-optimal outcomes and the best evidence supports maintaining a dry retina. Data from the HAWK and HARRIER clinical trials showed that, compared with aflibercept, patients treated with brolucizumab had less intra-retinal fluid, sub-retinal fluid and sub-RPE fluid at weeks 16, 48 and 96. In addition, a treatment-agnostic analysis of data from HAWK and HARRIER demonstrated that higher CST variability was associated with vision loss and worse NEI VFQ-25 scores. Although intra-retinal fluid is usually associated with poorer long-term visual outcomes, the presence of sub-retinal fluid does not prevent patients achieving good visual outcomes.

Abbreviations
CST, central subfield thickness; nAMD, neovascular age-related macular degeneration; NEI VFQ-25 National Eye Institute vision function questionnaire.

References
Sadda S. Brolucizumab in the current management of nAMD. Presented at WOC2020 Virtual
Dugel P, et al. Abstract presented at WOC2020 Virtual, 26–29 June 2020. [Abstract OP-092].
Sadda S. Fluid management in neovascular AMD. Presented at WOC2020 Virtual

Q2. Should the Portal Delivery System with ranibizumab be approved, which of the following patient groups could it be most suitable for?

  1. Newly diagnosed patient with nAMD
  2. Patients with stable disease requiring ranibizumab injections every 4–6 weeks
  3. Patients receiving aflibercept every 8 weeks
  4. Patients who have failed to respond to ranibizumab

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The Port Delivery System with ranibizumab is a refillable intraocular drug delivery reservoir that is being developed with a customized formulation of ranibizumab for the treatment of nAMD. It is most suitable for patients who need anti-VEGF treatment every 4-6 weeks.

Abbreviations
nAMD, neovascular age-related macular degeneration; VEGF, vascular endothelial growth factor

References
Pieramici D. Towards a more durable anti-VEGF therapy for neovascular AMD. Presented at WOC2020 Virtual

Q3. Which of the following options could you suggest exploring as a way of optimizing clinical management and care for patients with nAMD in a post-COVID-19 era?

  1. Increase nursing visits to provide vision assessments patients’ homes
  2. Extend time between anti-VEGF therapy injections for all patients
  3. Use local opticians for vision assessments to avoid travel to the clinic
  4. Smartphone/web-based app to allow remote home monitoring

Please try again

A smartphone and web-based app has been successfully used to monitor patients with nAMD during the COVID-19 lockdown by Moorfields Eye Hospital, London, UK. The app allows thresholding, monitoring and instant feedback to patients and scores can be monitored by physicians.

Abbreviations
nAMD, neovascular age-related macular degeneration; VEGF, vascular endothelial growth factor

References
Sims D. We are ready for home monitoring of NVAMD patients on follow up. Presented at WOC2020 Virtual

Q4. Your patient is a 68-year old female with a new diagnosis of nAMD in her right eye. Your patient is needle-phobic and very concerned about the experience of intravitreal injections. Based on the results of the HAWK and HARRIER clinical trials, what options could you consider to reduce the burden of therapy for your patient whilst optimizing visual function?

  1. Prescribe aflibercept Q8W
  2. Prescribe aflibercept PRN
  3. Prescribe brolucizumab Q12W dosing
  4. Prescribe brolucizumab PRN

Please try again

In the HAWK and HARRIER clinical trials patients were randomized equally to receive brolucizumab or aflibercept. Dosing of aflibercept was fixed at Q8W after the loading doses. After three monthly loading doses patients received brolucizumab Q12W unless disease activity was detected; presence of disease activity resulted in permanent Q8W dosing. In HAWK and HARRIER 82–85% patients who completed their first Q12W interval successfully remained on a Q12W interval until Week 48. Patients treated with brolucizumab had a lower risk of disease activity occurrence and therefore better disease control compared with aflibercept.

Abbreviations
nAMD, neovascular age-related macular degeneration; PRN, pro re nata, as needed; Q12W, every 12 weeks.

References
Hamilton R, et al. Abstract presented at WOC2020 Virtual, 26–29 June 2020. [Abstract OP-094].

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