Purpose To describe changes in intraocular pressure (IOP) in the ‘alternative treatments to Inhibit VEGF in Age-related choroidal Neovascularisation (IVAN)’ trial (registered as ISRCTN92166560).
Design Randomised controlled clinical trial with factorial design.
Participants Patients (n=610) with treatment naïve neovascular age-related macular degeneration were enrolled and randomly assigned to receive either ranibizumab or bevacizumab and to two regimens, namely monthly (continuous) or as needed (discontinuous) treatment.
Methods At monthly visits, IOP was measured preinjection in both eyes, and postinjection in the study eye.
Outcome measures The effects of 10 prespecified covariates on preinjection IOP, change in IOP (postinjection minus preinjection) and the difference in preinjection IOP between the two eyes were examined.
Results For every month in trial, there was a statistically significant rise in both the preinjection IOP and the change in IOP postinjection during the time in the trial (estimate 0.02 mm Hg, 95% CI 0.01 to 0.03, p<0.001 and 0.03 mm Hg, 95% CI 0.01 to 0.04, p=0.002, respectively). There was also a small but significant increase during the time in trial in the difference in IOP between the two eyes (estimate 0.01 mm Hg, 95% CI 0.005 to 0.02, p<0.001). There were no differences between bevacizumab and ranibizumab for any of the three outcomes (p=0.93, p=0.22 and p=0.87, respectively).
Conclusions Anti-vascular endothelial growth factor agents induce increases in IOP of small and uncertain clinical significance.
Trial registration number ISRCTN92166560.
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Contributors All authors have read and approved this manuscript. UC was the lead investigator. FG, JG and AJEF were all trial investigators. BCR, CAR and DMLJS are all members of the trials unit that run the trial. The data analysis for this paper was performed by DMLJS and supervised by CAR and BCR. The manuscript was written by AJEF and approved by all authors.
Funding The IVAN trial was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project number 07/36/01). The views and opinions expressed are those of the authors and do not necessarily reflect those of the Health Technology Assessment programme, National Institute for Health Research, the UK National Health Service, or the Department of Health.
Competing interests CAR, lecture fees from Novartis; BCR, lecture fee from Janssen-Clegg; FG, education grants from Bayer and Novartis and consultancy fees from Alimera, Allergan, Bayer and Novartis and research funds from Allergan, Bayer, Novartis, pSivida, Oraya and Sakura; JG, consultancy fees and research funding from Novartis; UC, consultancy fees from Alimera, Bayer, Genentech-Roche, Ophthotech and Oraya Therapeutics. Travel grants from Novartis and Ophthotech. Institution received funding from Allergan, Alcon, Bayer, Genentech-Roche, Notal Vision and Novartis.
Ethics approval 07/NIR03/37.
Provenance and peer review Not commissioned; externally peer reviewed.
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