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Randomized Controlled Trial
. 2016 Dec;100(12):1662-1667.
doi: 10.1136/bjophthalmol-2015-307595. Epub 2016 Apr 12.

Changes in intraocular pressure in study and fellow eyes in the IVAN trial

Alexander J E Foss  1 , Lauren J Scott  2 , Chris A Rogers  2 , Barney C Reeves  2 , Faruque Ghanchi  3 , Jonathan Gibson  4 , Usha Chakravarthy  5 ; IVAN study group
Affiliations
Randomized Controlled Trial

Changes in intraocular pressure in study and fellow eyes in the IVAN trial

Alexander J E Foss et al. Br J Ophthalmol. 2016 Dec.

Abstract

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.

Keywords: Glaucoma; Macula; Pharmacology.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Model for spikes in postinjection IOP (postinjection minus preinjection) in the study eye. Plot of the effects of covariates on IOP spikes in injected study eyes. The point estimates and 95% CIs are shown. FE, fellow eye; IOP, intraocular pressure; OU, both eyes; SE, study eye.
Figure 2
Figure 2
Model for preinjection IOP in the study eye. Plot of the effects of covariates on preinjection IOP in the study eye. The point estimates and 95% CIs are shown. FE, fellow eye; IOP, intraocular pressure; OU, both eyes; SE, study eye.
Figure 3
Figure 3
Model for difference in preinjection IOP between the study and fellow eyes (study eye minus fellow eye). Plot of the effects of covariates on difference in IOP between study and fellow eye. The point estimates and 95% CIs are shown. FE, fellow eye; IOP, intraocular pressure; SE, study eye.
See this image and copyright information in PMC

References

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