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Barney Reeves, Rebecca Evans, Simon P Harding, Andrew Lotery, Usha Chakravarthy; Long-term clinical management of neovascular AMD and visual acuity outcome in IVAN trial participants. Invest. Ophthalmol. Vis. Sci. 2019;60(9):1214. doi: https://doi.org/.
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To describe treatment frequency for neovascular age-related macular degeneration (nAMD), and visual acuity, in IVAN trial participants in the UK’s national health service during the 5 to 7 years since exiting the IVAN trial.
This extension studied participants who completed the IVAN clinical trial. Consent at enrolment allowed for collection of clinical data beyond trial exit but not for further research visits. A new ethics approval allowed surviving participants to be invited to attend a study visit, extraction of usual care visit data if they did not wish to attend and for deceased participants. We examined the medical records from trial exit (04/2010-11/2012) to end of follow-up (04/2016-06/2017) for usual care and research visits, extracting: visit date; distance visual acuity (DVA) for both study and fellow eyes; treatments for nAMD administered to either eye. We derived duration of study eye monitoring and annual injection rate. We fitted multiple regression models to investigate predictors of duration of study eye monitoring, injection rate during monitoring and DVA at end of follow-up (Cox, negative binomial and linear models respectively).
537 patients completed the IVAN trial at sites that participated in the extended follow-up; 5 withdrew when invited and 26 had no usual care or research data after exiting IVAN, leaving 506 in the analysis population. Low BCVA and older age at IVAN exit were associated with earlier cessation of monitoring; the median time to end of monitoring was 5.6 years. In the model for injection rate during follow-up, there was an interaction of BCVA at IVAN exit and year of follow-up (p<0.001); the injection rate increased in participants with the best BCVA at IVAN exit but otherwise decreased with time from IVAN exit. Original trial allocations did not influence DVA (end of extended follow-up). In the model for DVA (see figure), BCVA at IVAN exit (p<0.001), better seeing study eye (p=0.02), deprivation (p<0.001) and injection rate in the preceding year (p=0.002) were independent predictors of final DVA.
Monitoring and treatment were more likely to be discontinued in older participants and in eyes with poorer vision. Injection rate remained constant in participants with good vision for over 5 years. After adjusting for BCVA at trial exit, higher injection rate was associated with better visual acuity at end of follow-up.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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