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      Short term visual and structural outcomes of anti-vascular endothelial growth factor (anti-VEGF) treatment delay during the first COVID-19 wave: A pilot study

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          Abstract

          Regularly scheduled intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections are essential to maintaining and/or improving many ocular conditions including: neovascular age-related macular degeneration (nAMD), diabetic retinopathy, and retinal vein occlusions with macular edema (RVO). This study aims to assess the effect of unintended delays in anti-VEGF treatment during the first wave of the COVID-19 pandemic. This retrospective case series identified patients receiving regularly scheduled anti-VEGF intravitreal injections based on current procedural terminology (CPT) code at two practices in Minnesota. Diagnoses were limited to nAMD, diabetic macular edema (DME), proliferative diabetic retinopathy, and RVO. Patients were divided into two groups based on whether they maintained or delayed their follow-up visit by more than two weeks beyond the recommended treatment interval during the COVID-19 lockdown. The ‘COVID-19 lockdown’ was defined as the period after March, 28 th, 2020, when a lockdown was declared in Minnesota. We then compared the visual acuity and structural changes to the retina using ocular coherence tomography (OCT) to assess whether delayed treatment resulted in worse visual outcomes. A total of 167 eyes from 117 patients met criteria for inclusion in this study. In the delayed group, the average BCVA at the pre- and post-lockdown visits were 0.614 and 0.715 (logMAR) respectively (p = 0.007). Central subfield thickness (CST) increased from 341 to 447 in the DME delayed group (p = 0.03) while the CST increased from 301 to 314 (p = 0.4) in the nAMD delayed group. The results of this pilot study suggests that treatment delays may have a negative impact on the visual and anatomic outcomes of patients with nAMD and DME. Future studies with larger sample sizes are required for further investigation.

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          Ranibizumab for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE.

          Quan Nguyen, David M Brown, Dennis M Marcus … (2012)
          To evaluate the efficacy and safety of intravitreal ranibizumab in diabetic macular edema (DME) patients. Two parallel, methodologically identical, phase III, multicenter, double-masked, sham injection-controlled, randomized studies. Adults with vision loss from DME (best-corrected visual acuity [BCVA], 20/40-20/320 Snellen equivalent) and central subfield thickness ≥275 μm on time-domain optical coherence tomography (OCT). Monthly intravitreal ranibizumab (0.5 or 0.3 mg) or sham injections. Macular laser was available per-protocol-specified criteria. Proportion of patients gaining ≥15 letters in BCVA from baseline at 24 months. In RISE (NCT00473330), 377 patients were randomized (127 to sham, 125 to 0.3 mg, 125 to 0.5 mg). At 24 months, 18.1% of sham patients gained ≥15 letters versus 44.8% of 0.3-mg (P<0.0001; difference vs sham adjusted for randomization stratification factors, 24.3%; 95% confidence interval [CI], 13.8-34.8) and 39.2% of 0.5-mg ranibizumab patients (P<0.001; adjusted difference, 20.9%; 95% CI, 10.7-31.1). In RIDE (NCT00473382), 382 patients were randomized (130 to sham, 125 to 0.3 mg, 127 to 0.5 mg). Significantly more ranibizumab-treated patients gained ≥15 letters: 12.3% of sham patients versus 33.6% of 0.3-mg patients (P<0.0001; adjusted difference, 20.8%; 95% CI, 11.4-30.2) and 45.7% of 0.5-mg ranibizumab patients (P<0.0001; adjusted difference, 33.3%; 95% CI, 23.8-42.8). Significant improvements in macular edema were noted on OCT, and retinopathy was less likely to worsen and more likely to improve in ranibizumab-treated patients. Ranibizumab-treated patients underwent significantly fewer macular laser procedures (mean of 1.8 and 1.6 laser procedures over 24 months in the sham groups vs 0.3-0.8 in ranibizumab groups). Ocular safety was consistent with prior ranibizumab studies; endophthalmitis occurred in 4 ranibizumab patients. The total incidence of deaths from vascular or unknown causes, nonfatal myocardial infarctions, and nonfatal cerebrovascular accidents, which are possible effects from systemic vascular endothelial growth factor inhibition, was 4.9% to 5.5% of sham patients and 2.4% to 8.8% of ranibizumab patients. Ranibizumab rapidly and sustainably improved vision, reduced the risk of further vision loss, and improved macular edema in patients with DME, with low rates of ocular and nonocular harm. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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            Ranibizumab and bevacizumab for treatment of neovascular age-related macular degeneration: two-year results.

            Daniel Martin, Maureen Maguire, Stuart Fine … (2012)
            To describe effects of ranibizumab and bevacizumab when administered monthly or as needed for 2 years and to describe the impact of switching to as-needed treatment after 1 year of monthly treatment. Multicenter, randomized clinical trial. Patients (n = 1107) who were followed up during year 2 among 1185 patients with neovascular age-related macular degeneration who were enrolled in the clinical trial. At enrollment, patients were assigned to 4 treatment groups defined by drug (ranibizumab or bevacizumab) and dosing regimen (monthly or as needed). At 1 year, patients initially assigned to monthly treatment were reassigned randomly to monthly or as-needed treatment, without changing the drug assignment. Mean change in visual acuity. Among patients following the same regimen for 2 years, mean gain in visual acuity was similar for both drugs (bevacizumab-ranibizumab difference, -1.4 letters; 95% confidence interval [CI], -3.7 to 0.8; P = 0.21). Mean gain was greater for monthly than for as-needed treatment (difference, -2.4 letters; 95% CI, -4.8 to -0.1; P = 0.046). The proportion without fluid ranged from 13.9% in the bevacizumab-as-needed group to 45.5% in the ranibizumab monthly group (drug, P = 0.0003; regimen, P 0.60). The proportion of patients with 1 or more systemic serious adverse events was higher with bevacizumab than ranibizumab (39.9% vs. 31.7%; adjusted risk ratio, 1.30; 95% CI, 1.07-1.57; P = 0.009). Most of the excess events have not been associated previously with systemic therapy targeting vascular endothelial growth factor (VEGF). Ranibizumab and bevacizumab had similar effects on visual acuity over a 2-year period. Treatment as needed resulted in less gain in visual acuity, whether instituted at enrollment or after 1 year of monthly treatment. There were no differences between drugs in rates of death or arteriothrombotic events. The interpretation of the persistence of higher rates of serious adverse events with bevacizumab is uncertain because of the lack of specificity to conditions associated with inhibition of VEGF. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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              Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study.

              David M Brown, Mark Michels, Peter K Kaiser … (2009)
              The 2-year, phase III trial designated Anti-vascular endothelial growth factor (VEGF) Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization (CNV) in Age-related Macular Degeneration (ANCHOR) compared ranibizumab with verteporfin photodynamic therapy (PDT) in treating predominantly classic CNV. Multicenter, international, randomized, double-masked, active-treatment-controlled clinical trial. Patients with predominantly classic, subfoveal CNV not previously treated with PDT or antiangiogenic drugs. Patients were randomized 1:1:1 to verteporfin PDT plus monthly sham intraocular injection or to sham verteporfin PDT plus monthly intravitreal ranibizumab (0.3 mg or 0.5 mg) injection. The need for PDT (active or sham) retreatment was evaluated every 3 months using fluorescein angiography (FA). The primary, intent-to-treat efficacy analysis was at 12 months, with continued measurements to month 24. Key measures included the percentage losing or=15 letters from baseline, and mean change over time in VA score and FA-assessed lesion characteristics. Adverse events were monitored. Of 423 patients (143 PDT, 140 each in the 2 ranibizumab groups), the majority (>or=77% in each group) completed the 2-year study. Consistent with results at month 12, at month 24 the VA benefit from ranibizumab was statistically significant (P or=15 letters (vs. 6.3% of PDT group); and, on average, VA was improved from baseline by 8.1 to 10.7 letters (vs. a mean decline of 9.8 letters in PDT group). Changes in lesion anatomic characteristics on FA also favored ranibizumab (all comparisons P<0.0001 vs. PDT). Overall, there was no imbalance among groups in rates of serious ocular and nonocular adverse events. In the pooled ranibizumab groups, 3 of 277 (1.1%) patients developed presumed endophthalmitis in the study eye (rate per injection = 3/5921 [0.05%]). In this 2-year study, ranibizumab provided greater clinical benefit than verteporfin PDT in patients with age-related macular degeneration with new-onset, predominantly classic CNV. Rates of serious adverse events were low. Proprietary or commercial disclosure may be found after the references.
              Article 0 comments Cited 147 times – based on 0 reviews     Review now
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                Author and article information

                Contributors
                Ameay V. Naravane:
                ORCID: https://orcid.org/0000-0003-2570-7857
                Role: Data curationRole: Formal analysisRole: Funding acquisitionRole: InvestigationRole: MethodologyRole: Writing – original draft
                Rusdeep Mundae: Role: Data curationRole: Writing – original draft
                Yujia Zhou: Role: Data curationRole: Writing – original draft
                Christopher Santilli: Role: Data curationRole: Writing – original draft
                Frederik J. G. M. van Kuijk: Role: InvestigationRole: Writing – review & editing
                Hossein Nazari: Role: Writing – review & editing
                Justin Yamanuha: Role: InvestigationRole: SupervisionRole: Writing – review & editing
                Geoffrey G. Emerson: Role: InvestigationRole: Writing – review & editing
                Dara D. Koozekanani: Role: InvestigationRole: Writing – original draft
                Sandra R. Montezuma: Role: ConceptualizationRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Demetrios G. Vavvas: Role: Editor
                Journal
                Journal ID (nlm-ta): PLoS One
                Journal ID (iso-abbrev): PLoS One
                Journal ID (publisher-id): plos
                Journal ID (pmc): plosone
                Title: PLoS ONE
                Publisher: Public Library of Science (San Francisco, CA USA )
                ISSN (Electronic): 1932-6203
                Publication date (Electronic): 17 February 2021
                Publication date Collection: 2021
                Publication date PMC-release: 17 February 2021
                Volume: 16
                Issue: 2
                Electronic Location Identifier: e0247161
                Affiliations
                [1 ] Department of Ophthalmology and Visual Neuroscience, University of Minnesota, Minneapolis, Minnesota, United States of America
                [2 ] University of Minnesota Medical School, Minneapolis, Minnesota, United States of America
                [3 ] The Retina Center, Minneapolis, Minnesota, United States of America
                Massachusetts Eye & Ear Infirmary, Harvard Medical School, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                https://orcid.org/0000-0003-2570-7857
                Article
                Publisher ID: PONE-D-20-38470
                DOI: 10.1371/journal.pone.0247161
                PMC ID: 7888661
                PubMed ID: 33596257
                SO-VID: 23f1444e-14df-4dc9-9c62-dfc1c17c9332
                Copyright © © 2021 Naravane et al
                License:

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                Date received : 7 December 2020
                Date accepted : 2 February 2021
                Page count
                Figures: 5, Tables: 2, Pages: 11
                Funding
                Funded by: VitreoRetinal Surgery 2020 Research Award
                Award Recipient :
                ORCID: https://orcid.org/0000-0003-2570-7857
                Funded by: Minnesota Lions Foundation
                Funded by: Knobloch Chair Professorship
                Award Recipient :
                Funding was provided by the Minnesota Lions Foundation, the Knobloch Chair Professorship (SRM), and VitreoRetinal Surgery 2020 Research Award (AN). The funding organizations had no role in the design or conduct of this research.
                Categories
                Subject: Research Article
                Subject: Medicine and Health Sciences
                Subject: Medical Conditions
                Subject: Infectious Diseases
                Subject: Viral Diseases
                Subject: Covid 19
                Subject: Medicine and Health Sciences
                Subject: Epidemiology
                Subject: Pandemics
                Subject: Biology and Life Sciences
                Subject: Neuroscience
                Subject: Cognitive Science
                Subject: Cognitive Psychology
                Subject: Perception
                Subject: Sensory Perception
                Subject: Vision
                Subject: Visual Acuity
                Subject: Biology and Life Sciences
                Subject: Psychology
                Subject: Cognitive Psychology
                Subject: Perception
                Subject: Sensory Perception
                Subject: Vision
                Subject: Visual Acuity
                Subject: Social Sciences
                Subject: Psychology
                Subject: Cognitive Psychology
                Subject: Perception
                Subject: Sensory Perception
                Subject: Vision
                Subject: Visual Acuity
                Subject: Biology and Life Sciences
                Subject: Neuroscience
                Subject: Sensory Perception
                Subject: Vision
                Subject: Visual Acuity
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Head
                Subject: Eyes
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Head
                Subject: Eyes
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Ocular System
                Subject: Eyes
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Ocular System
                Subject: Eyes
                Subject: Medicine and Health Sciences
                Subject: Endocrinology
                Subject: Endocrine Disorders
                Subject: Diabetes Mellitus
                Subject: Medicine and Health Sciences
                Subject: Medical Conditions
                Subject: Metabolic Disorders
                Subject: Diabetes Mellitus
                Subject: Biology and Life Sciences
                Subject: Anatomy
                Subject: Ocular System
                Subject: Ocular Anatomy
                Subject: Retina
                Subject: Medicine and Health Sciences
                Subject: Anatomy
                Subject: Ocular System
                Subject: Ocular Anatomy
                Subject: Retina
                Subject: Medicine and Health Sciences
                Subject: Diagnostic Medicine
                Subject: Diagnostic Radiology
                Subject: Tomography
                Subject: Research and Analysis Methods
                Subject: Imaging Techniques
                Subject: Diagnostic Radiology
                Subject: Tomography
                Subject: Medicine and Health Sciences
                Subject: Radiology and Imaging
                Subject: Diagnostic Radiology
                Subject: Tomography
                Subject: Research and Analysis Methods
                Subject: Research Design
                Subject: Pilot Studies
                Custom metadata
                Data Availability Data cannot be shared publicly because they include HIPAA protected PHI. Data are available from the University of Minnesota Institutional Data Access / Ethics Committee (contact via irb@ 123456umn.edu ) for researchers who meet the criteria for access to confidential data. The data underlying the results presented in the study are available from (M Health Fairview ( irb@ 123456umn.edu ); The Retina Center ( info@ 123456retinadocs.com ).
                Outbreaks COVID-19

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                ScienceOpen disciplines: Uncategorized

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