OSLI Retina

February 2021

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62 © Ophthalmic Surgery, Lasers & Imaging Retina ■ C L I N I C A L S C I E N C E ■ Impact of Delayed Time to Treatment on Visual Outcomes in Neovascular AMD: Data From the HARBOR Study Roger A. Goldberg, MD, MBA; Lauren F. Hill, MS; Tatiana Davis, PhD; Carlos Quezada Ruiz, MD BACKGROUND AND OBJECTIVE: To determine the potential impact on visual outcomes of delayed treatment initiation in patients with neovascular age-related macular degeneration (nAMD). PATIENTS AND METHODS: Post hoc analysis of anti- vascular endothelial growth factor treatment-na- ïve patients with nAMD from HARBOR. Time to treatment was defined as first ranibizumab injec- tion date minus screening date. Comparisons were made between the prompt (≤ 6 days) versus de- layed (> 10 days) treatment groups. Main outcome measures were best-corrected visual acuity (BCVA) change over time, BCVA, number of ranibizumab injections, and proportion of 3-line gainers/losers. RESULTS: In HARBOR, more than 50% of patients received their first injection within 7 days of screening, with mean (median) time to treatment of 4.6 (5) and 15.9 (14) days for the prompt and de- layed treatment groups, respectively. Mean (95% confidence interval [CI]) BCVA change from base- line to Month 24 was 9.1 (7.4-10.8) and 8.8 (6.7- 10.8) Early Treatment Diabetic Retinopathy Study letters in the prompt (n = 395) and delayed (n = 230) treatment groups, respectively. Mean (95% CI) total number of ranibizumab injections for the as- needed arms was 12.4 (11.6-13.3) and 11.4 (10.3- 12.4) for the prompt and delayed treatment groups, respectively. CONCLUSION: In HARBOR, time from screening to first ranibizumab injection did not seem to signifi- cantly affect mean BCVA change or number of in- jections. [Ophthalmic Surg Lasers Imaging Retina. 2021;52:62-69.] INTRODUCTION The natural history of neovascular age-related macular degeneration (nAMD) is characterized by visual decline over time. It is the No. 1 cause of se- vere visual loss and legal blindness among people over age 65 years in North America, Europe, Aus- tralia, and Asia. 1,2 The introduction of anti-vascular endothelial growth factor (VEGF) therapy has dra- matically changed the clinical course by arresting the vision loss seen in untreated nAMD and improving vision in some patients. 3, 4 Untreated nAMD affects the outer retina, damaging and distorting the architec- ture through leakage of fluid and blood, resulting in potentially irreversible damage to the photoreceptors. Several studies suggest that a delay in time from diagnosis or symptom onset to initial treatment with anti-VEGF therapy leads to worse visual outcomes in nAMD. Rauch et al. showed that patients treated within 1 month of patient-reported symptom onset had better visual outcomes than those treated with- in 6 months (P < .001). 5 Rasmussen et al. compared the time from confirmed diagnosis of nAMD to first treatment. 6 Patients who received initial ranibizum- ab (Lucentis; Genentech, South San Francisco, CA) From Bay Area Retina Associates, Walnut Creek, California (RAG); Genen- tech, Inc., South San Francisco, California (LFH, TD, CQR); and Clinica de Ojos Garza Viejo, San Pedro Garza Garcia, Nuevo León, Mexico (CQR). Originally submitted April 20, 2020. Revision received October 12, 2020. Accepted for publication November 20, 2020. Portions of these data were presented at the 35th Annual Meeting of the American Society of Retina Specialists, August 11–15, 2017, Boston, Mas- sachusetts. Supported by Genentech, Inc., a member of the Roche Group, for the study and third-party writing assistance, which was provided by Jack W. Pike, PhD, of Envision Pharma Group. Dr. Goldberg has received grants from and is on an advisory board for Genentech, has received grants from and is a consultant for Carl Zeiss Meditec, and has received grants from Santen during the conduct of this study. Ms. Hill is an employee of Genentech and has done contract work for Aerpio during the conduct of this study. Drs. Davis and Quezada Ruiz are employees of and have equity in Genentech. Address correspondence to Roger A. Goldberg, MD, MBA, Bay Area Retina Associates, 365 Lennon Lane, Suite 250, Walnut Creek, CA 94598; e-mail: rgoldberg.eyemd@gmail.com. doi: 10.3928/23258160-20210201-02

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