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

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.