Retreatment Rate Comparison Between Anti-VEGF Regimens for ROP
Nimesh Patel, MD:
Hi everyone. I’m Nimesh Patel from Boston Children’s Hospital at Massachusetts Eye and Ear Infirmary. I’m here to discuss some updates and new data on intravitreal injections for retinopathy of prematurity, which medication is best, and what’s the right dose. This is the second report of the retinopathy of Prematurity Injection Consortium. I have these financial disclosures. So retinopathy of prematurity is been treated with laser in the past and more recently with anti VEGF injections. There however, is limited real world data available at this time. So this study aims to look at which medication could be best or decrease the amount of re-treatments for retinopathy of prematurity in terms of vitro vitreal injections.
Here’s some pride data that led to this study. We initially did a multi-center consecutive case series of ROP patients treated with intravitreal injections from 2007 to 2020. This included 23 sites, 16 of which were in the USA. We found that there were some significant differences between the national and international groups with the national babies being treated younger, earlier, and more often. This led to a difficulty in trying to determine which medication was best because across the cohort there was a lot of differences. So to study this, we had to eliminate the international sites and really just look at a clean set of data within the US.
Another difficulty is that now it seems there’s a lot of re-treatments being done for prophylactic purposes. So what we did in this study is we included all patients that were retreated with injections and lasers as well as injection only and laser within eight weeks of treatment and injection only re-treatments. We had a really interesting finding here where we found that in all across the board that Ranibizumab was associated with more retreatments than Bevacizumab, which was a little bit surprising to be honest, that it was this high of a rate of difference.
The other thing that was interesting is that in the real world, there are much more retreatments in comparison to clinical trials. So here in two clinical trials, one is the BEAT-ROP, looking at Bevacizumab, and the other one is rainbow, looking at Ranibizumab. Our data here from our real world studies in orange on both sides, comparing the two different medications. It is pretty clear here that there are much more re-treatments in the real world than they were in clinical trials. And I think this potentially reflects the fact that a lot of real world doctors are using laser as prophylactic, but also are generally more cautious when they’re not being monitored in a clinical trial setting.
One of the new points to come out of this study, and very important because there are currently a lot of dose deescalation studies for ROP, is that lower doses did result in worry treatment with Bevacizumab. This is very important because we’re trying to find the lowest dose to prevent systemic intortion and potentially any negative side effects. However, it’s clear here that as you decrease the dose of Bevacizumab, there are more treatments for retinopathy of premature.
So the conclusions of this study say that retreatment rates are much higher in the real world than compared to clinical trials in retinopathy of prematurity. Future trials will need to account for global variances and rates of prophylactic laser. There’s a much different rate of treatment in the US than there are internationally, and when we look at global trials, we’ll have to record this. There is a higher rate of retreatments with Ranibizumab than there is with Bevacizumab. This doesn’t necessarily make a comment on which medication you should use, but just this is something to be aware of. The thought being that Ranibizumab has a shorter half-life than Bevacizumab leading to more retreatments. And finally, that lower doses of Bevacizumab are associated with more retreatments than standard dose Bevacizumab. I’d like to thank all the ROPIC study site groups that were a part of this trial, as well as the writing team, and the paper is recently published in ophthalmology. Thank you.