June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Port delivery system with ranibizumab in the treatment of diabetic retinopathy without center-involved diabetic macular edema: primary analysis results of the phase 3 Pavilion trial.
Author Affiliations & Notes
  • Andres Emanuelli
    a. Emanuelli Research and Development, Arecibo, Puerto Rico
    Department of Ophthalmology, b. University of Puerto Rico, School of Medicine, San Juan, Puerto Rico
  • Nancy M Holekamp
    Pepose Vision Institute, Chesterfield, Missouri, United States
  • Paul Latkany
    Genentech Inc, South San Francisco, California, United States
  • Christopher Brittain
    Genentech Inc, South San Francisco, California, United States
  • Dena Howard
    Roche Products Ltd, Welwyn Garden City, Hertfordshire, United Kingdom
  • Anjana Santhanakrishnan
    Genentech Inc, South San Francisco, California, United States
  • Monica Wetzel-Smith
    Genentech Inc, South San Francisco, California, United States
  • Carlos Quezada-Ruiz
    Genentech Inc, South San Francisco, California, United States
  • Varun Malhotra
    Genentech Inc, South San Francisco, California, United States
  • Dante Joseph Pieramici
    California Retina Consultants, Santa Barbara, California, United States
  • Footnotes
    Commercial Relationships   Andres Emanuelli Novartis, Genentech, Code C (Consultant/Contractor), Novartis, Novartis Institute of Biomedical Research, Regeneron Pharmaceuticals, Roche/Genentech, Adverum Biotechnologies, Kodiak Sciences, Apellis, Ophthea, Nanoscope Therapeutics, RegenexBio, Abbvie, Ocuterra, Code F (Financial Support); Nancy Holekamp 4DMT, AGTC, Allergan, Annexon, Apellis, Bayer, Biogen, Boehringer, Cardinal, Clearside, Editas, EyePoint, Gemini, Genentech, Inc., Gyroscope, Medpace, Medscape, Nacuity, NGM, Notal Vision, Novartis, Ocuphire, Outlook, Regeneron, Roche, Laboratoires Théa, Stealth Bio, Vial, Code C (Consultant/Contractor), Genentech, Inc., Gemini, Gyroscope, Notal Vision, Code F (Financial Support), AbbVie, Apellis, Genentech, Inc., Regeneron, Bausch + Lomb, Code S (non-remunerative); Paul Latkany Genentech, Inc, Code E (Employment), Genentech, Inc, Code I (Personal Financial Interest); Christopher Brittain Genentech, Inc, Code E (Employment), Genentech, Inc, Code I (Personal Financial Interest); Dena Howard Roche Products Ltd., Code E (Employment), Roche Products Ltd., Code I (Personal Financial Interest); Anjana Santhanakrishnan Genentech, Inc, Code E (Employment), Genentech, Inc, Code I (Personal Financial Interest); Monica Wetzel-Smith Genentech, Inc, Code E (Employment), Genentech, Inc, Code I (Personal Financial Interest); Carlos Quezada-Ruiz Genentech, Inc, Code E (Employment), Genentech, Inc, Code I (Personal Financial Interest); Varun Malhotra Genentech, Inc, Code E (Employment), Genentech, Inc, Code I (Personal Financial Interest); Dante Pieramici Adverum, Clearside, Gemini, Genentech, Inc., Iveric Bio, NGM, Regeneron, REGENXBIO, Unity, Code C (Consultant/Contractor), Alimera, Adverum, Annexon, Apellis, Chengdu Kanghong, Clearside, Eyepoint, F. Hoffmann-La Roche Ltd., Genentech, Inc., Iveric Bio, Kodiak, NGM, Novartis, Ocular Therapeutix, Occulis, Ophthea, Oxular, Oxurion, Regeneron, UNITY, Valo, Code F (Financial Support), Gemini, Code I (Personal Financial Interest), Genentech, Inc., Regeneron, Code S (non-remunerative)
  • Footnotes
    Support  Yes, 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 2023, Vol.64, 3754. doi:
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      Andres Emanuelli, Nancy M Holekamp, Paul Latkany, Christopher Brittain, Dena Howard, Anjana Santhanakrishnan, Monica Wetzel-Smith, Carlos Quezada-Ruiz, Varun Malhotra, Dante Joseph Pieramici; Port delivery system with ranibizumab in the treatment of diabetic retinopathy without center-involved diabetic macular edema: primary analysis results of the phase 3 Pavilion trial.. Invest. Ophthalmol. Vis. Sci. 2023;64(8):3754.

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

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Abstract

Purpose : Diabetic retinopathy (DR) is a leading cause of vision loss in working-age adults. There is an unmet need for treatment strategies that sustain the clinical benefits of intravitreal anti–vascular endothelial growth factor (VEGF) in DR, while reducing the overall treatment burden. The Port Delivery System with ranibizumab (PDS) is an innovative drug delivery system for continuous delivery of a customized formulation of ranibizumab into the vitreous that is being evaluated for patients with DR. The phase 3 Pavilion trial is evaluating the efficacy, safety, and pharmacokinetics of PDS 100 mg/mL with refill-exchanges every 36 weeks (PDS Q36W) in patients with DR without center-involved diabetic macular edema (CI-DME).

Methods : Pavilion (NCT04503551) is an ongoing, multicenter, randomized, visual assessor–masked trial, in which eligible patients (planned n = 160) were randomized (5:3) to the PDS Q36W arm (n = ~100) or the clinical observation arm (n = ~60), respectively. Eligible patients were aged ≥ 18 years, with moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (Early Treatment Diabetic Retinopathy Study [ETDRS] Diabetic Retinopathy Severity Scale [DRSS] level 47 or 53) and were DR-treatment naïve in the study eye. Inclusion criteria include diagnosis of diabetes mellitus, glycosylated hemoglobin ≤ 12%, and best-corrected visual acuity of ≥ 69 ETDRS letters (~Snellen 20/40). The prespecified primary endpoint is the proportion of patients with a ≥ 2-step improvement from baseline on the ETDRS-DRSS at week 52.

Results : At the time of abstract submission, the trial is ongoing. However, by the time of the proposed ARVO presentation, primary endpoint data, along with key safety and secondary efficacy endpoints at week 52, will be available and shared.

Conclusions : PDS has the potential to provide the clinical benefits of intravitreal anti-VEGF therapy without the need for frequent intravitreal injections in patients with DR. The primary endpoint and key efficacy and safety data from the Pavilion trial of PDS with refill-exchanges Q36W will be presented.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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