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Clinical Trial
. 2020 Jan;4(1):3-12.
doi: 10.1016/j.oret.2019.06.001. Epub 2019 Jun 11.

Visual Acuity Outcomes after Anti-Vascular Endothelial Growth Factor Treatment for Neovascular Age-Related Macular Degeneration: Age-Related Eye Disease Study 2 Report Number 19

Affiliations
Clinical Trial

Visual Acuity Outcomes after Anti-Vascular Endothelial Growth Factor Treatment for Neovascular Age-Related Macular Degeneration: Age-Related Eye Disease Study 2 Report Number 19

Tiarnan D Keenan et al. Ophthalmol Retina. 2020 Jan.

Abstract

Purpose: To analyze best-corrected visual acuity (BCVA) outcomes after anti-vascular endothelial growth factor (VEGF) treatment for neovascular age-related macular degeneration (AMD).

Design: Prospective cohort study of participants enrolled in a clinical trial of oral supplements and receiving anti-VEGF therapy in routine clinical practice.

Participants: Age-Related Eye Disease Study 2 (AREDS2) participants (50-85 years of age) whose eyes met AREDS2 inclusion criteria at baseline (no late AMD, BCVA ≥20/100, no previous anti-VEGF injections) but received at least 1 anti-VEGF injection for incident neovascular AMD during follow-up.

Methods: Participants underwent refracted BCVA testing, ophthalmoscopic examination, and stereoscopic color fundus photography at baseline and annual study visits over 5 years. Self-reports of anti-VEGF injections (numbers, dates, and names of drug) were collected at baseline and annual study visits and during telephone calls every 6 months.

Main outcome measures: Primary outcome measures were mean refracted BCVA and proportions of eyes with BCVA of 20/40 or better and 20/200 or worse. An exploratory outcome measure was the mean number of self-reported anti-VEGF injections.

Results: One thousand one hundred five eyes of 986 AREDS2 participants met the inclusion criteria; of these, 977 participants (99.1%) underwent at least 1 posttreatment visit. At the first and subsequent annual examinations after the first injection, mean refracted BCVAs were 68.0 letters (Snellen equivalent, 20/40), 66.1 letters, 64.7 letters, 63.2 letters, and 61.5 letters (Snellen equivalent, 20/60). Proportions of eyes with BCVA of 20/40 or better were 59.3%, 55.1%, 53.5%, 50.6%, and 49.7%, and those with BCVA of 20/200 or worse were 5.5%, 8.6%, 9.4%, 12.4%, and 14.4%. Mean annual numbers of self-reported anti-VEGF injections per eye were 2.9, 3.9, 3.3, 3.1, and 3.0.

Conclusions: Refracted BCVA data were obtained in a clinical trial environment but were related to anti-VEGF treatment administered in normal clinical practice. Visual outcomes declined slowly with increased follow-up time: mean BCVA decreased by approximately 1.5 to 2 letters per year. At 5 years, half of eyes achieved BCVA of 20/40 or better, but approximately one sixth showed BCVA of 20/200 or worse. These data may be useful in assessing the long-term effects of anti-VEGF therapy.

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Conflict of interest statement

Conflicts of Interest:

No conflicting relationship exists for these authors: Susan Vitale, Tiarnan Keenan, Elvira Agrón, Amitha Domalpally, Traci Clemons, Emily Chew

Andrew Antoszyk: Consultant Genentech/Roche, Opthea, and JAEB

Michael Elman: Consultant to Genentech/Roche, receives research funding from Genentech, Alcon/Novartis, Thrombogenics, Apellis Pharmaceuticals, Neurotech, YD Global Life Science, and Emmes

Figures

Figure 1.
Figure 1.
Diagram showing the timeline and nomenclature of the Age-Related Eye Disease Study 2 (AREDS2) annual study visits in relation to the first anti-VEGF injection for each eye, i.e., demonstrating the ‘first post-treatment study visit’ and subsequent post-treatment study visits.
Figure 2.
Figure 2.
Mean refracted best-corrected visual acuity (BCVA) of study eyes (Age-Related Eye Disease Study 2, AREDS2) over time, according to first and subsequent post-treatment study visits. Alongside the mean BCVA for eyes in this study (diamonds) are shown equivalent BCVA data for the Comparison of AMD Treatments Trial (CATT; circles); these are shown half-way between AREDS2 annual study visits because the CATT data were captured at yearly intervals after the first anti-VEGF injection, whereas the AREDS2 data were captured at variable periods of 0–11.9 months after first anti-VEGF injection (and yearly thereafter).
Figure 3.
Figure 3.
Proportions of study eyes with different levels of refracted Snellen best-corrected visual acuity (BCVA) over time, according to first and subsequent post-treatment study visits.
Figure 4.
Figure 4.
Cumulative self-reported numbers of anti-VEGF injections per study eye from initiation of treatment, according to first and subsequent post-treatment study visits. The boxes extend from the first to the third quartiles, while the whiskers extend from the minimum to the maximum values. The horizontal lines indicate the median values, while the crosses show the means; the means are also given numerically beside the plot.

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