Ranibizumab Implant Continues to Impress for Neovascular AMD

The ranibizumab port delivery system (PDS; Susvimo) was noninferior to monthly ranibizumab (Lucentis) and provided comparable vision and controlled retinal thickness through 96 weeks in patients with neovascular age-related macular degeneration (AMD), according to research presented at the American Society of Retina Specialists (ASRS) meeting.

In this exclusive video, study author Aleksandra Rachitskaya, MD, of the Cole Eye Institute of the Cleveland Clinic, discusses the end-of-study updated data from the phase III ARCHWAY trial.

The following is a transcript of her remarks:

It’s such a pleasure to talk today about the presentation that we delivered at the ASRS Retina Meeting in New York. This presentation focused on particular analysis of the ARCHWAY study, a pivotal phase III trial that compared monthly ranibizumab to Port Delivery System. Port Delivery System is implanted surgically, and then is refilled every 24 weeks on schedule.

And it’s been shown before and we’ve presented it before that Port Delivery System was shown to be non-inferior and equivalent to monthly ranibizumab at the primary endpoint. And also we’ve presented the end-of-study results, and it was once again shown to be non-inferior to monthly ranibizumab in terms of change in best corrected visual acuity.

So this study, the way it’s different is we were interested in looking at what happens with the fluid in these patients. As we know, we look at macular degeneration patients and we obtain OCT [optical coherence tomography] at every visit. So this study really wanted to focus on the fluid.

So the way the fluid was assessed, patients at each visit obtained OCT. And so initial grading was whether there was any fluid at all. And then if the fluid was present, then it was looked if in the center one millimeter, we had any intraretinal or subretinal fluid.

Now just to remind everybody, in this trial patients, before they were randomized, they were already treated with on average five anti-VEGF injections. So in the beginning of the trial about 40 to 50% of patients had some intraretinal or subretinal fluid, which makes sense because they have been pretreated. And when we look at the end of the trial, in both arms the number stayed very similar — about 55 or so percent of patients had intraretinal or subretinal fluid on the OCT scans.

When we look at visual acuity, the visual acuity was, as we know, very good in these patients and the overall presence of intraretinal subretinal fluid didn’t affect visual acuity. Now we took a more closer look and wanted to look at the center one millimeter, and what happens at the center one millimeter.

So we looked at the number of patients who had any subretinal fluid first in the center one millimeter. And the number of those patients was pretty small — about 30% in each arm. And when we look at each arm, so monthly ranibizumab versus Port Delivery System, we saw that patients who had subretinal fluid — there was really no difference in their visual acuities, and they had good visual acuity.

Now, when we looked at the center one millimeters and we looked at the intraretinal fluid, we saw that patients who had intraretinal fluid — and I have to preface, it’s even smaller numbers. It’s only 15%, which is good, right, that only 15% of patients have fluid. So we are looking at small numbers. But what we saw that patients who had intraretinal fluid in the center one millimeter had worse visual acuity. And we noticed also that when there was intraretinal fluid present in the center one millimeter, there was a trend for better maintenance of vision in the port delivery system compared to ranibizumab group.

So I think when we look at this study big picture, in the ARCHWAY trial we really had good visual acuity. The patients, if they had any subretinal intraretinal fluid, when we compare the two arms they looked very similar in terms of visual acuity. They had good visual acuity. When we looked at one millimeter center subretinal fluid, patients had good visual acuity and there was no difference between the two arms.

And then we saw this signal and once again, the numbers are small, but when it came to intraretinal fluid in the center one millimeter, the PDS arm appeared to maintain vision better than ranibizumab arm.

But in summary, I think we have to pause and think, we really have good visual acuity in both arms and good control of fluid.