Grantor Statement:
Supported from an Educational Grant from Adverum Biotechnologies, Inc.

Learning Objectives

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

Describe the current treatment options for nAMD. Identify the unmet needs with the currently available AMD treatments.
Categorize and critique based on early clinical trial data the surgical and nonsurgical sustained-delivery AMD treatment options currently under investigation.
Categorize and critique based on early clinical trial data the various types of gene therapy currently under investigation for the treatment of nAMD.
Interpret the available literature and compare a subretinal surgical delivery with an intravitreal approach.

Accreditation and Designation Statement

Provided by Evolve Medical Education

Accreditation Statement
Evolve Medical Education LLC (Evolve) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement
Evolve designates this live activity for a maximum of 1.25 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 post-test, evaluation and submit for credit.

Course Viewing Requirements

Supported Browsers:
Internet Explorer 11 for Windows
Edge (recent versions; Chromium-based) for Windows
Google Chrome (recent versions) for Windows, Mac OS, iOS, Android, or Linux
Mozilla Firefox (recent versions) for Windows, Mac OS, iOS, Android, or Linux
Safari (recent versions) for Mac OSX, or iOS

Hardware Requirements:
4GB+ RAM

Recommended internet speed 5Mbps+

Faculty and Disclosures

Faculty:

Arshad M. Khanani, MD, MA
Managing Partner
Director of Clinical Research
Director of Fellowship
Sierra Eye Associates
Clinical Associate Professor
University of Nevada
Reno School of Medicine
Reno, Nevada

Charles C. Wykoff, MD, PhD
Director of Research
Retina Consultants of Houston
Houston, TX

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 conflict of interests relating to the topics of this educational activity. Evolve has full policies in place that will identify and resolve all conflicts of interest prior to this educational activity.

The following faculty/staff members have the following financial relationships with commercial interests:
Arshad M. Khanani, MD, MA; and or spouse; has had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant: Aerpio, Allegro, Allergan, Graybug, Genentech, Gyroscope, Kodiak, Notal Vision, Novartis, Opthea, Orbit BioMedical, Oxurion, Polyphotonix, Recens Medical, and Regenexbio. Grant/Research Support: Advernum, Aerpio, Allergan, Gemini, Genentech, Graybug, Gyroscope, Kodiak, Novartis, Opthea, Oxurion, Recens Medical, and Regenxbio. Speaker’s Bureau: Allergan, Genentech, and Novartis.

Charles C. Wykoff, MD, PhD, FACS, and/or spouse/partner has had a financial agreement or affiliation during the past year with the following commercial interests in the form of Consultant: Alimera, Allergan, Genentech, Novartis, and Regeneron. Grant/Research Support: Allergan, Genentech, Novartis, and Regeneron. Speaker’s Bureau: Regeneron.

The Evolve staff and planners have no financial relationships with commercial interests.

Nisha Mukherjee, MD, peer reviewer, has no financial relationships with commercial interests.

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 Adverum Biotechnologies, Inc.

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Pretest

1. Please rate your confidence in your ability to interpret early clinical trial dataonthe various types of gene therapy currently under investigation for the treatment of neovascular age-related macular degeneration (nAMD)(based on a scale of 1 to 5, with 1 = “Not at all confident” and 5= “Very confident”).*
a. 1 b. 2 c. 3 d. 4 e. 5
2. ADVM-022 is a gene therapy vector designed for continuous delivery of aflibercept. How is this therapy administered?*
- a) Intravitreal injection
- b) Subretinal injection during pars plana vitrectomy
- c) Suprachoroidal injection
- d) Intracameral injection
3. According to phase 1 data of the OPTIC study, at a median of 72-week follow-up for patients in the high dose ADVM-022 group, what percentage of patients needed a rescue injection after treatment?*
- a) 0%
- b) 5%
- c) 10%
- d) 15%
4. How was RGX-314 administered to patients in clinical trials?*
- a) Intravitreal injection
- b) Subretinal injection during pars plana vitrectomy
- c) Suprachoroidal injection
- d) Intracameral injection
5. During the RGX-314 clinical trials, all of the following were criteria for supplemental anti-VEGF treatment EXCEPT:*
- a) choroidal neovascularization-related increased, new, or persistent fluid
- b) Vision loss of at least 5 letters associated with fluid
- c) New ocular hemorrhage
- d) Subjective visual change
6. What was the most common adverse event reported in the RGX-314 clinical trials?*
- a) Retinal pigmentary changes
- b) Postoperative conjunctival hemorrhage
- c) Postoperative inflammation
- d) Retinal hemorrhage
7. In the higher dosed cohorts 3 through 5 of the RGX-314 clinical trials, what percentage reduction in anti-VEGF injections was seen after treatment?*
- a) ~10-25%
- b) ~25-50%
- c) ~50-60%
- d) ~60-80%
8. An 88-year-old male with nAMD on monthly injections of aflibercept is well controlled, but fears that he cannot maintain his current schedule for much longer because he is unable to find a driver to bring him to his appointments. He asks you about the potential for gene therapy to treat his disease in the future. He is very reluctant to go to the operating room, but comfortable with intravitreal injections. You discuss the gene therapies that are currently in clinical trial with the patient. Which of the following options would be the best potential future therapy for this patient to address his concerns?*
- a) RGX-314 treatment
- b) ADVM-022 treatment
- c) Ranibizumab treatment
- d) Bevacizumab treatment

Video Resources

Instructions

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

Step 1 of 2

1. Please rate your confidence in your ability to interpret early clinical trial dataonthe various types of gene therapy currently under investigation for the treatment of neovascular age-related macular degeneration (nAMD)(based on a scale of 1 to 5, with 1 = “Not at all confident” and 5= “Very confident”).*
a. 1 b. 2 c. 3 d. 4 e. 5
2. ADVM-022 is a gene therapy vector designed for continuous delivery of aflibercept. How is this therapy administered?*
- a) Intravitreal injection
- b) Subretinal injection during pars plana vitrectomy
- c) Suprachoroidal injection
- d) Intracameral injection
3. According to phase 1 data of the OPTIC study, at a median of 72-week follow-up for patients in the high dose ADVM-022 group, what percentage of patients needed a rescue injection after treatment?*
- a) 0%
- b) 5%
- c) 10%
- d) 15%
4. How was RGX-314 administered to patients in clinical trials?*
- a) Intravitreal injection
- b) Subretinal injection during pars plana vitrectomy
- c) Suprachoroidal injection
- d) Intracameral injection
5. During the RGX-314 clinical trials, all of the following were criteria for supplemental anti-VEGF treatment EXCEPT:*
- a) choroidal neovascularization-related increased, new, or persistent fluid
- b) Vision loss of at least 5 letters associated with fluid
- c) New ocular hemorrhage
- d) Subjective visual change
6. What was the most common adverse event reported in the RGX-314 clinical trials?*
- a) Retinal pigmentary changes
- b) Postoperative conjunctival hemorrhage
- c) Postoperative inflammation
- d) Retinal hemorrhage
7. In the higher dosed cohorts 3 through 5 of the RGX-314 clinical trials, what percentage reduction in anti-VEGF injections was seen after treatment?*
- a) ~10-25%
- b) ~25-50%
- c) ~50-60%
- d) ~60-80%
8. An 88-year-old male with nAMD on monthly injections of aflibercept is well controlled, but fears that he cannot maintain his current schedule for much longer because he is unable to find a driver to bring him to his appointments. He asks you about the potential for gene therapy to treat his disease in the future. He is very reluctant to go to the operating room, but comfortable with intravitreal injections. You discuss the gene therapies that are currently in clinical trial with the patient. Which of the following options would be the best potential future therapy for this patient to address his concerns?*
- a) RGX-314 treatment
- b) ADVM-022 treatment
- c) Ranibizumab treatment
- d) Bevacizumab treatment
Profession:*
- MD/DO
- NP
- Nurse/APN
- PA
- OD
- Other
Years in Practice:*
- >20
- 11-20
- 6-10
- 1-5
- <1
Patients Seen Per Week ( with the disease targeted in this activity):*
- 0
- 1-15
- 16-30
- 31-50
- 50+
Region:*
- Northeast
- Northwest
- Midwest
- Southeast
- Southwest
Setting:*
- Solo Practice
- Community Hospital
- Government or VA
- Group Practice
- Other
- I do not actively practice
Models of Care:*
- Fee for Service
- ACO
- Patient-Centered Medical Home
- Capitation
- Bundled Payments
- Other

Did the program meet the following educational objectives?*

	Agree	Neutral	Disagree
Describe the current treatment options for nAMD.Identify the unmet needs with the currently available AMD treatments.
Categorize and critique based on early clinical trial data the surgical and nonsurgical sustained-delivery AMD treatment options currently under investigation.
Categorize and critique based on early clinical trial data the various types of gene therapy currently under investigation for the treatment of nAMD.
Interpret the available literature and compare a subretinal surgical delivery with an intravitreal approach.

	Yes	No
The design of the program was effective for the content conveyed
The content supported the identified learning objectives
The content was free of commercial bias
The content was relative to your practice
The faculty was effective
You were satisfied overall with the activity
Would you recommend this program to your colleagues

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Gene Therapy: An Emerging Frontier in the Treatment of Neovascular Diseases

Webinar Credits: 1.25

Expiration Date: Thursday, September 30, 2021

Release Date: September 16, 2020

Learning Objectives

Accreditation and Designation Statement

Participation Method

Faculty and Disclosures

Disclaimer

Pretest

Video Resources

Test

Instructions

Step 1 of 2

Gene Therapy: An Emerging Frontier in the Treatment of Neovascular Diseases

Webinar Credits: 1.25

Expiration Date: Thursday, September 30, 2021

Release Date: September 16, 2020

Learning Objectives

Accreditation and Designation Statement

Participation Method

Faculty and Disclosures

Disclaimer

Please log in to view this course

Pretest

Video Resources

Test

Instructions

Step 1 of 2