At the 2023 ASRS annual meeting in Seattle, Washington, Ursula Schmidt-Erfurth, MD, shared the latest information on the GALE extension study.
Ursula Schmidt-Erfurth, MD, spoke with our team to share information on the GALE extension study at the 2023 ASRS annual meeting.
Editor's note - This transcript has been edited for clarity.
My name is Ursula Schmidt-Erfurth. I'm the Chairman of the Department of Ophthalmology at the Medical University of Vienna. I'm also the director of the Vienna Reading Center, and leading the Ophthalmic Image Analysis Group, which is a computer science group.
Here at the ASRS, I will report about the extension of the OAKS and DERBY study, which are Phase 3 studies using pegcetacoplan treatment to limit the progression of GA [geographic atrophy] disease. There is an extension that has now started, called the GALE study, which will continue up to 60 months. At the moment, we have the first 6 months of this extension available. The group of patients that is of highest interest for us are those patients that were in the sham group over the 2 previous years of the Phase 3 study. These are lesions with very active disease. They have advanced quite substantially, and now they are rolled over to active treatment.
This will give us insight about whether in advanced lesions, the complement inhibition will work. How do we measure this? We measure it by using AI based OCT analysis. We can identify the photoreceptor degeneration zone, which is a change at the level of the EZ [ellipsoid zone] line, and we can identify RPE [retinal pigment epithelium] loss. These are the 2 layers that are of relevance for disease activity and for the therapeutic effect. We found when patients crossed over, there was an immediate effect on photoreceptor preservation, which was almost 100%. That is quite a positive signal that even in advanced lesions pegcetacoplan treatment, anti-complement inhibition works very effectively. It also worked at the level of the RPE. There was a reduction by 19% in the progression of the lesion at the level of the RPE.
Overall, this is very consistent [with] what we have found during the [inaudible] study, the Phase 2 and Phase 3 OAKS and DERBY studies, but now in advanced lesions and within only an observation of 6 months. This is a summary of the patients that had finished the Phase 3. 75% of patients did this despite the heavy COVID burden, and 85% of those patients have entered into GALE, so it's a significant number of patients.
With these positive results, a tool was developed that is using OCT based AI analysis. It's called the GA monitor. It can be found on the Heidelberg AppWay, and it will allow clinicians in Europe, where the tool already has regulatory approval, to use this in clinical practice. [Also,] for the US colleagues, in an exploratory manner, to identify patients that do have disease activity, and that will also experience a therapeutic effect based on real data on photoreceptors and RPE.