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First-year visual acuity outcomes of providing Aflibercept according to the view study protocol for age-related macular degeneration

First-year visual acuity outcomes of providing Aflibercept according to the view study protocol for age-related macular degeneration
First-year visual acuity outcomes of providing Aflibercept according to the view study protocol for age-related macular degeneration
Purpose: Aflibercept has the potential advantage of reducing capacity problems by allowing 2 monthly visits for patients with neovascular macular degeneration (nAMD) compared with monthly pro re nata regimens that are the most commonly used in the United Kingdom. This study aimed to report the visual outcomes achieved in routine clinical practice using the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) protocol at 1 year and compare with trials data and other real-world reports.

Design: Retrospective data analysis from an electronic medical record.

Participants: Consecutive series of treatment-naïve patients initiated on aflibercept for nAMD at least 1 year before data extraction.

Methods: Data were anonymized and remotely extracted from 16 centers in the United Kingdom that use the same electronic medical record (EMR) system (Medisoft Ophthalmology; Medisoft Limited, Leeds, UK).

Main Outcome Measures: The minimum data set defined before first data entry and mandated by the EMR included age, gender, visual acuity, injection episodes, and complications.

Results: The mean age was 80.0 years (median, 81.0 years) and 63.7% were women. During the first year of treatment with aflibercept, 1840 treatment-naïve eyes of 1682 patients received a median of 8 (mean, 7.0) injections at a median of 8 (mean, 7.3) visits. The mean baseline visual acuity was 53.7 letters, improving to 58.8 letters (+5.1-letter gain) at 1 year. In first-treated eyes, the respective figures were 52.7 letters at baseline and 58.2 letters at 1 year, a gain of +5.5 letters. The proportion achieving 70 letters or more increased from 16.4% at baseline to 33.7% at 1 year, and 92% avoided moderate visual loss at 1 year.

Conclusions: The visual acuity outcomes are comparable to randomized trials and better than many previous real-world data collections, with a mean +5.1-letter gain at 1 year compared with +8.4 letters in the integrated analysis of the VIEW 1 and VIEW 2 studies. Early visual gains were maintained through the year. Collection of outcomes beyond clinical trials can have limitations but better reflect the full pool of patients actually treated and are important to determine whether a particular treatment is performing as expected. Such data also have the potential to improve services by setting up a mechanism to compare sites.
337-343
Talks, James S.
3c9e94ea-9991-424c-936c-3058530435f3
Lotery, Andrew J.
5ecc2d2d-d0b4-468f-ad2c-df7156f8e514
Ghanchi, Faruque
0f38ccc6-1cf4-4550-b7be-0cda92ea5d83
Sivaprasad, Sobha
7cd590d6-18f0-4ae1-8ace-4b35833c2f03
Johnston, Robert L.
1810fbd8-4b0e-486b-847a-38d1fe340c38
Patel, Nishal
7f2753f1-1bba-4865-9221-3403f05a4d96
McKibbin, Martin
227d9f5a-b07a-42bd-b6bc-212937543295
Bailey, Clare
f86729be-c141-4085-8acf-ef90a889e5a4
Mahmood, Sajjad
4d683bfb-b232-4a64-91bc-9b7f6ab89d2e
Talks, James S.
3c9e94ea-9991-424c-936c-3058530435f3
Lotery, Andrew J.
5ecc2d2d-d0b4-468f-ad2c-df7156f8e514
Ghanchi, Faruque
0f38ccc6-1cf4-4550-b7be-0cda92ea5d83
Sivaprasad, Sobha
7cd590d6-18f0-4ae1-8ace-4b35833c2f03
Johnston, Robert L.
1810fbd8-4b0e-486b-847a-38d1fe340c38
Patel, Nishal
7f2753f1-1bba-4865-9221-3403f05a4d96
McKibbin, Martin
227d9f5a-b07a-42bd-b6bc-212937543295
Bailey, Clare
f86729be-c141-4085-8acf-ef90a889e5a4
Mahmood, Sajjad
4d683bfb-b232-4a64-91bc-9b7f6ab89d2e

Talks, James S., Lotery, Andrew J., Ghanchi, Faruque, Sivaprasad, Sobha, Johnston, Robert L., Patel, Nishal, McKibbin, Martin, Bailey, Clare and Mahmood, Sajjad (2016) First-year visual acuity outcomes of providing Aflibercept according to the view study protocol for age-related macular degeneration. Ophthalmology, 123 (2), 337-343. (doi:10.1016/j.ophtha.2015.09.039). (PMID:26578446)

Record type: Article

Abstract

Purpose: Aflibercept has the potential advantage of reducing capacity problems by allowing 2 monthly visits for patients with neovascular macular degeneration (nAMD) compared with monthly pro re nata regimens that are the most commonly used in the United Kingdom. This study aimed to report the visual outcomes achieved in routine clinical practice using the VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD (VIEW) protocol at 1 year and compare with trials data and other real-world reports.

Design: Retrospective data analysis from an electronic medical record.

Participants: Consecutive series of treatment-naïve patients initiated on aflibercept for nAMD at least 1 year before data extraction.

Methods: Data were anonymized and remotely extracted from 16 centers in the United Kingdom that use the same electronic medical record (EMR) system (Medisoft Ophthalmology; Medisoft Limited, Leeds, UK).

Main Outcome Measures: The minimum data set defined before first data entry and mandated by the EMR included age, gender, visual acuity, injection episodes, and complications.

Results: The mean age was 80.0 years (median, 81.0 years) and 63.7% were women. During the first year of treatment with aflibercept, 1840 treatment-naïve eyes of 1682 patients received a median of 8 (mean, 7.0) injections at a median of 8 (mean, 7.3) visits. The mean baseline visual acuity was 53.7 letters, improving to 58.8 letters (+5.1-letter gain) at 1 year. In first-treated eyes, the respective figures were 52.7 letters at baseline and 58.2 letters at 1 year, a gain of +5.5 letters. The proportion achieving 70 letters or more increased from 16.4% at baseline to 33.7% at 1 year, and 92% avoided moderate visual loss at 1 year.

Conclusions: The visual acuity outcomes are comparable to randomized trials and better than many previous real-world data collections, with a mean +5.1-letter gain at 1 year compared with +8.4 letters in the integrated analysis of the VIEW 1 and VIEW 2 studies. Early visual gains were maintained through the year. Collection of outcomes beyond clinical trials can have limitations but better reflect the full pool of patients actually treated and are important to determine whether a particular treatment is performing as expected. Such data also have the potential to improve services by setting up a mechanism to compare sites.

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More information

Accepted/In Press date: 26 September 2015
e-pub ahead of print date: 12 November 2015
Published date: February 2016
Organisations: Clinical & Experimental Sciences

Identifiers

Local EPrints ID: 390077
URI: https://eprints.soton.ac.uk/id/eprint/390077
PURE UUID: 7c431e12-163e-47ae-923d-eafa7cd686a8
ORCID for Andrew J. Lotery: ORCID iD orcid.org/0000-0001-5541-4305

Catalogue record

Date deposited: 17 Mar 2016 16:47
Last modified: 10 Dec 2019 01:46

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Contributors

Author: James S. Talks
Author: Faruque Ghanchi
Author: Sobha Sivaprasad
Author: Robert L. Johnston
Author: Nishal Patel
Author: Martin McKibbin
Author: Clare Bailey
Author: Sajjad Mahmood

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