Aleksandra Rachitskaya, MD: The Promise of PDS Despite Retinal Fluid Presence

New findings suggest vision outcomes were generally comparable in the phase 3 Archway trial between the Port Delivery System with ranibizumab (PDS) and monthly ranibizumab in neovascular age-related macular generation (nAMD) treatment, regardless of subretinal fluid presence.

Moreover, the data show the incidence of retinal fluid at week 96 was comparable across each treatment arm.

The findings were presented at the American Society of Retina Specialists 40th Annual Scientific Meeting.

In an interview with HCPLive, Aleksandra Rachitskaya, MD, Cleveland Clinic Cole Eye Institute, described the processes of the post-hoc analysis and what the investigators set out to uncover from the pivotal phase 3 trial regarding the presence of fluid.

The team looked at the 96 weeks of study results and compared patients who had any fluid in the macula as well as intraretinal fluid and subretinal fluid in the center 1mm.

“When we looked at fluid anywhere in the macula, any intraretinal or subretinal fluid, we saw that about the same percentage of patients in both arms had the fluid to begin with, it was about 50%,” Rachitskaya said. “And that persisted throughout the study.”

She noted that this could be expected as patients were treated with anti-VEGF prior to randomization, so not every patient had fluid. When investigators looked at the vision if there was any fluid in the macula, no difference was found between each study arm.

Then, investigators wanted to take a deeper look and investigated the center 1 mm. In the presence of subretinal fluid, there was no difference at 96 weeks in visual outcomes when comparing the two arms of the study. However, when they compared the two arms in intraretinal fluid in the center 1mm, they found intraretinal fluid did lead to worse visual outcomes.

Rachitskaya noted that there was a small number of patients included in the analysis, as less than 15% of patients had any intraretinal fluid.

“We did see a trend that in patients in the PDS arm, the visual outcomes were slightly better than in the monthly ranibizumab arm,” she added. “When we looked at the presence of intraretinal fluids, there seemed to be some kind of protective effect.”

She highlighted that PDS may provide good visual outcomes, despite the presence of any fluid and more real world data will help confirm this notion. She noted her excitement of the environment where the better durability of drugs is now a real possibility and now the introduction of surgical techniques for patients who may not be strong candidates for injections.

“I think it really increases our arsenal of opportunities to provide the best care of patients with nAMD and there's also ongoing trials in diabetic macular edema and retinopathy for the PDS and we'll be awaiting those results,” Rachitskaya concluded.