Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Jan;8(1):e001192.
doi: 10.1136/bmjophth-2022-001192.

Palmerston North Interventional Rapid Avastin Treat and Extend (PIRATE) study protocol; meeting the medical retina service needs of our ageing population

Louis Antoine Bonnet  1 , Vidit Singh  2 , John Ah-Chan  2
Affiliations

Palmerston North Interventional Rapid Avastin Treat and Extend (PIRATE) study protocol; meeting the medical retina service needs of our ageing population

Louis Antoine Bonnet et al. BMJ Open Ophthalmol. 2023 Jan.

Abstract

Introduction: As the rates of age-related macular denegation exponentially increase, new innovation is required to address the challenges faced by our ageing population. The aim of the Palmerston North Interventional Rapid Avastin Treat and Extend (PIRATE) study is to establish the safety and efficacy of rapid treatment extension of bevacizumab (Avastin) in patients with low-risk neovascular age-related macular degeneration (nAMD).

Methods and analysis: The PIRATE study is a monocentric, non-blinded, open-label randomised control trial. Participants over the age of 50 years with low-risk nAMD characteristics will be recruited in a prospective manner and randomised into treatment and control groups. Rapid treatment extension by 4 weeks will be applied in the treatment group, with the standard 2-week treatment extension occurring among controls. Participants will enter the trial after initial treatment induction consisting of three bevacizumab injections, 1 month apart. The primary outcome of best-corrected visual acuity will be assessed along with predetermined secondary outcomes at a study duration of 12 months (initial) and 24 months (total).

Trial registration number: ACTRN12622001246774p.

Keywords: Clinical Trial; Macula; Retina; Vision.

PubMed Disclaimer

Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Proposed treatment regimen of study groups.
See this image and copyright information in PMC

References

    1. National Health Committee . Age-Related macular degeneration. Wellington, New Zealand: National health Committee, 2015. Available: http://nhc.health.govt.nz [Accessed 8 Oct 2022].
    1. Macular Degeneration New Zealand . Socioeconomic cost of macular degeneration in New Zealand. Deloitte access economics. Available: https://static1.squarespace.com/static/5dcba244e3fb8952b16c79fd/t/6119d7... [Accessed 8 Oct 2022].
    1. RANZCO . NZ national guidelines for management for neovascular. New Zealand: AMD, 2018. https://ranzco.edu/policies_and_guideli/nz-national-guidelines-for-manag...
    1. Jones SR, Carley S, Harrison M. An introduction to power and sample size estimation. Emerg Med J 2003;20:453–8. 10.1136/emj.20.5.453 - DOI - PMC - PubMed
    1. Ohji M, Takahashi K, Okada AA, et al. . Efficacy and Safety of Intravitreal Aflibercept Treat-and-Extend Regimens in Exudative Age-Related Macular Degeneration: 52- and 96-Week Findings from ALTAIR : A Randomized Controlled Trial. Adv Ther 2020;37:1173–87. 10.1007/s12325-020-01236-x - DOI - PMC - PubMed

Publication types